Research Spotlight

Lamm, B.M., Moore, K.R., Hentges, M., Martin, L.R. and Ernst, J.J. (2021). “Avascular Necrosis of the First Metatarsal: A Case of Second Metatarsal Bone Transport with External Fixation.” J Foot Ankle Surg Feb 8;S1067-2516(19)30119-X. [Epub ahead of print].

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Avascular necrosis (AVN) after bunion surgery is an unfortunate complication which can be devastating and painful. We present a case report of gradual medializing transport of the second metatarsal with external fixation to repair a large bone defect caused by AVN affecting >50% of the first metatarsal. The procedure was performed on a 49-year-old female who suffered AVN after failed bunion surgery. At 12-month follow up, first ray position and length were maintained. With respect to the second ray, there were no clinically significant issues. The second digit was mildly elevated but there was no frank instability of the toe or of the Lisfranc complex. The patient was pain free and had returned to her desired daily activities.

Jain, S.S., Cohen, D.J., Zhang, Z., Uriel, N., Sayer, G., Lindenfeld, J., Abraham, W.T., Mack, M.J., Stone, G.W. and Arnold, S.V. (2021). “Defining a Clinically Important Change in 6-Minute Walk Distance in Patients With Heart Failure and Mitral Valve Disease.” Circ Heart Fail Mar 5;CIRCHEARTFAILURE120007564. [Epub ahead of print].

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Patients with heart failure (HF) and secondary mitral regurgitation (SMR) have substantial impairment in patient-reported health status and functional status, both of which may improve rapidly after edge-to-edge transcatheter mitral valve repair (TMVr). As such, health status (assessed with the Kansas City Cardiomyopathy Questionnaire-Overall Summary score [KCCQ-OS]) and functional status (assessed with 6-minute walk distance [6MWD]) are increasingly incorporated as key end points in ongoing trials of novel HF therapies. It is therefore important to understand the magnitude of clinically relevant changes in these metrics. [No abstract; excerpt from article].

Thourani, V.H., George, I., Rucinskas, K., Kalinauskas, G., Janusauskas, V., Zakarkaite, D., Ailawadi, G., Smith, R. and Mack, M.J. (2021). “First in human experience with an epicardial beating heart device for secondary mitral regurgitation.” J Thorac Cardiovasc Surg 161(3): 949-958.e944.

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OBJECTIVE: We describe a novel, off-pump, epicardial implant that is intended to reshape both the mitral valve annulus and the left ventricle (LV) in those with secondary mitral regurgitation (MR). METHODS: Five patients underwent an epicardial implant with the Mitral Touch device (Mitre Medical Corp, Morgan Hill, Calif), during concomitant off-pump coronary artery bypass for secondary MR. The median age was 71.2 years; 4 patients had severe MR and 1 moderate. Patients were followed for 1 year with transthoracic echocardiography and computed tomography. Safety, cardiac remodeling, and MR were assessed by an independent core laboratory. RESULTS: One patient died within 30 days from nondevice-related organ failure and the remaining 4 survived through 1-year follow-up. Implant technical success was 100% and took an average of 52 minutes. Paired computed tomography showed mean left ventricular end-systolic volume remodeling at 1 and 12 months of -35% and -31%, respectively. They averaged left atrial end-systolic volume remodeling of -12% and -15% at 1 and 12 months. Right ventricular end-systolic volume changes of -19% and -8% and right atrial end-systolic volume remodeling of -5% and 1%, at the 1- and 12-month time points were noted. Regurgitant volume by transthoracic echocardiography decreased by 46% and 44% and the ejection fraction from 34.6% to 32.1% and 39.5%, at 1 and 12 months, respectively. There were no device-related complications reported to 1 year. CONCLUSIONS: The Epicardial Mitral Touch System for Mitral Regurgitation (ENRAPT-MR) study demonstrates a first-in-man, off-pump, epicardial repair of secondary MR. Procedural safety and geometric correction of the mitral valve apparatus and LV was achieved. Further studies in the United States are underway.

Mack, M.J., Lindenfeld, J., Abraham, W.T., Kar, S., Lim, D.S., Mishell, J.M., Whisenant, B.K., Grayburn, P.A., Rinaldi, M.J., Kapadia, S.R., Rajagopal, V., Sarembock, I.J., Brieke, A., Rogers, J.H., Marx, S.O., Cohen, D.J., Weissman, N.J. and Stone, G.W. (2021). “3-Year Outcomes of Transcatheter Mitral Valve Repair in Patients With Heart Failure.” J Am Coll Cardiol 77(8): 1029-1040.

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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, transcatheter mitral valve repair (TMVr) resulted in fewer heart failure hospitalizations (HFHs) and lower mortality at 24 months in patients with heart failure (HF) with mitral regurgitation (MR) secondary to left ventricular dysfunction compared with guideline-directed medical therapy (GDMT) alone. OBJECTIVES: This study determined if these benefits persisted to 36 months and if control subjects who were allowed to cross over at 24 months derived similar benefit. METHODS: This study randomized 614 patients with HF with moderate-to-severe or severe secondary MR, who remained symptomatic despite maximally tolerated GDMT, to TMVr plus GDMT versus GDMT alone. The primary effectiveness endpoint was all HFHs through 24-month follow-up. Patients have now been followed for 36 months. RESULTS: The annualized rates of HFHs per patient-year were 35.5% with TMVr and 68.8% with GDMT alone (hazard ratio [HR]: 0.49; 95% confidence interval [CI]: 0.37 to 0.63; p < 0.001; number needed to treat (NNT) = 3.0; 95% CI: 2.4 to 4.0). Mortality occurred in 42.8% of the device group versus 55.5% of control group (HR: 0.67; 95% CI: 0.52 to 0.85; p = 0.001; NNT = 7.9; 95% CI: 4.6 to 26.1). Patients who underwent TMVr also had sustained 3-year improvements in MR severity, quality-of-life measures, and functional capacity. Among 58 patients assigned to GDMT alone who crossed over and were treated with TMVr, the subsequent composite rate of mortality or HFH was reduced compared with those who continued on GDMT alone (adjusted HR: 0.43; 95% CI: 0.24 to 0.78; p = 0.006). CONCLUSIONS: Among patients with HF and moderate-to-severe or severe secondary MR who remained symptomatic despite GDMT, TMVr was safe, provided a durable reduction in MR, reduced the rate of HFH, and improved survival, quality of life, and functional capacity compared with GDMT alone through 36 months. Surviving patients who crossed over to device treatment had a prognosis comparable to those originally assigned to transcatheter therapy. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation [COAPT]; NCT01626079).

Kawashima, H., Takahashi, K., Ono, M., Hara, H., Wang, R., Gao, C., Sharif, F., Mack, M.J., Holmes, D.R., Morice, M.C., Head, S.J., Kappetein, A.P., Thuijs, D., Milojevic, M., Noack, T., Mohr, F.W., Davierwala, P.M., Serruys, P.W. and Onuma, Y. (2021). “Mortality 10 Years After Percutaneous or Surgical Revascularization in Patients With Total Coronary Artery Occlusions.” J Am Coll Cardiol 77(5): 529-540.

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BACKGROUND: The long-term clinical benefit after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in patients with total occlusions (TOs) and complex coronary artery disease has not yet been clarified. OBJECTIVES: The objective of this analysis was to assess 10-year all-cause mortality in patients with TOs undergoing PCI or CABG. METHODS: This is a subanalysis of patients with at least 1 TO in the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) study, which investigated 10-year all-cause mortality in the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trial, beyond its original 5-year follow-up. Patients with TOs were further stratified according to the status of TO recanalization or revascularization. RESULTS: Of 1,800 randomized patients to the PCI or CABG arm, 460 patients had at least 1 lesion of TO. In patients with TOs, the status of TO recanalization or revascularization was not associated with 10-year all-cause mortality, irrespective of the assigned treatment (PCI arm: 29.9% vs. 29.4%; adjusted hazard ratio [HR]: 0.992; 95% confidence interval [CI]: 0.474 to 2.075; p = 0.982; and CABG arm: 28.0% vs. 21.4%; adjusted HR: 0.656; 95% CI: 0.281 to 1.533; p = 0.330). When TOs existed in left main and/or left anterior descending artery, the status of TO recanalization or revascularization did not have an impact on the mortality (34.5% vs. 26.9%; adjusted HR: 0.896; 95% CI: 0.314 to 2.555; p = 0.837). CONCLUSIONS: At 10-year follow-up, the status of TO recanalization or revascularization did not affect mortality, irrespective of the assigned treatment and location of TOs. The present study might support contemporary practice among high-volume chronic TO-PCI centers where recanalization is primarily offered to patients for the management of angina refractory to medical therapy when myocardial viability is confirmed. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972).