Cardiology

Wood, D. A., Z. Krajcer, J. Sathananthan, N. Strickman, C. Metzger, W. Fearon, M. Aziz, L. F. Satler, R. Waksman, M. Eng, S. Kapadia, A. Greenbaum, M. Szerlip . . . and J. G. Webb (2019). “Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device.” Circ Cardiovasc Interv 12(7): 1-11 e007258.

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BACKGROUND: Open surgical closure and small-bore suture-based preclosure devices have limitations when used for transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or percutaneous thoracic endovascular aortic aneurysm repair. The MANTA vascular closure device is a novel collagen-based technology designed to close large bore arteriotomies created by devices with an outer diameter ranging from 12F to 25F. In this study, we determined the safety and effectiveness of the MANTA vascular closure device. METHODS AND RESULTS: A prospective, single arm, multicenter investigation in patients undergoing transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or thoracic endovascular aortic aneurysm repair at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were accessed site-related vascular injury or bleeding complications. A total of 341 patients, 78 roll-in, and 263 in the primary analysis cohort, were entered in the study between November 2016 and September 2017. For the primary analysis cohort, transcatheter aortic valve replacement was performed in 210 (79.8%), and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 53 (20.2%). The 14F MANTA was used in 42 cases (16%), and the 18F was used in 221 cases(84%). The mean effective sheath outer diameter was 22F (7.3 mm). The mean time to hemostasis was 65+/-157 seconds with a median time to hemostasis of 24 seconds. Technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) of cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: 4 received a covered stent (1.5%), 3 had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%). CONCLUSIONS: In a selected population, this study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, and thoracic endovascular aortic aneurysm repair devices. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880.

Vasudevan, A., J. W. Choi, G. A. Feghali, S. R. Lander, L. Jialiang, J. M. Schussler, R. C. Stoler, R. C. Vallabhan, C. E. Velasco and P. A. McCullough (2019). “Event dependence in the analysis of cardiovascular readmissions postpercutaneous coronary intervention.” J Investig Med 67(6): 943-949.

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Recurrent hospitalizations are common in longitudinal studies; however, many forms of cumulative event analyses assume recurrent events are independent. We explore the presence of event dependence when readmissions are spaced apart by at least 30 and 60 days. We set up a comparative framework with the assumption that patients with emergency percutaneous coronary intervention (PCI) will be at higher risk for recurrent cardiovascular readmissions than those with elective procedures. A retrospective study of patients who underwent PCI (January 2008-December 2012) with their follow-up information obtained from a regional database for hospitalization was conducted. Conditional gap time (CG), frailty gamma (FG) and conditional frailty models (CFM) were constructed to evaluate the dependence of events. Relative bias (%RB) in point estimates using CFM as the reference was calculated for comparison of the models. Among 4380 patients, emergent cases were at higher risk as compared with elective cases for recurrent events in different statistical models and time-spaced data sets, but the magnitude of HRs varied across the models (adjusted HR [95% CI]: all readmissions [unstructured data]-CG 1.16 [1.09 to 1.22], FG 1.45 [1.33 to 1.57], CFM 1.24 [1.16 to 1.32]; 30-day spaced-CG1.14 [1.08 to 1.21], FG 1.28 [1.17 to 1.39], CFM 1.17 [1.10 to 1.26]; and 60-day spaced-CG 1.14 [1.07 to 1.22], FG 1.23 [1.13 to 1.34] CFM 1.18 [1.09 to 1.26]). For all of the time-spaced readmissions, we found that the values of %RB were closer to the conditional models, suggesting that event dependence dominated the data despite attempts to create independence by increasing the space in time between admissions. Our analysis showed that independent of the intercurrent event duration, prior events have an influence on future events. Hence, event dependence should be accounted for when analyzing recurrent events and challenges contemporary methods for such analysis.

Vasudevan, A., J. W. Choi, G. A. Feghali, A. Y. Kluger, S. R. Lander, K. M. Tecson, M. Sathyamoorthy, J. M. Schussler, R. C. Stoler, R. C. Vallabhan, C. E. Velasco, A. Yoon and P. A. McCullough (2019). “First and recurrent events after percutaneous coronary intervention: implications for survival analyses.” Scand Cardiovasc J Jul 25: 1-6. [Epub ahead of print].

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Objectives. Using composite endpoints and/or only first events in clinical research result in information loss and alternative statistical methods which incorporate recurrent event data exist. We compared information-loss under traditional analyses to alternative models. Design. We conducted a retrospective analysis of patients who underwent percutaneous coronary intervention (Jan2010-Dec2014) and constructed Cox models for a composite endpoint (readmission/death), a shared frailty model for recurrent events, and a joint frailty (JF) model to simultaneously account for recurrent and terminal events and evaluated the impact of heart failure (HF) on the outcome. Results. Among 4901 patients, 2047(41.8%) experienced a readmission or death within 1 year. Of those with recurrent events, 60% had >/=1 readmission and 6% had >4; a total of 121(2.5%) patients died during follow-up. The presence of HF conferred an adjusted Hazard ratio (HR) of 1.32 (95% CI: 1.18-1.47, p < .001) for the risk of composite endpoint (Cox model), 1.44 (95% CI: 1.36-1.52, p < .001) in the frailty model, and 1.34 (95% CI:1.22-1.46, p < .001) in the JF model. However, HF was not associated with death (HR 0.87, 95% CI: 0.52-1.48, p = .61) in the JF model. Conclusions. Using a composite endpoint and/or only the first event yields substantial loss of information, as many individuals endure >1 event. JF models reduce bias by simultaneously providing event-specific HRs for recurrent and terminal events.

Scheeren, T. W. L. and M. A. E. Ramsay (2019). “New Developments in Hemodynamic Monitoring.” J Cardiothorac Vasc Anesth 33 Suppl 1: S67-s72.

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Hemodynamic monitoring is an essential part of the perioperative management of the cardiovascular patient. It helps to detect hemodynamic alterations, diagnose their underlying causes, and optimize oxygen delivery to the tissues. Furthermore, hemodynamic monitoring is necessary to evaluate the adequacy of therapeutic interventions such as volume expansion or vasoactive medications. Recent developments include the move from static to dynamic variables to assess conditions such as cardiac preload and fluid responsiveness and the transition to less-invasive or even noninvasive monitoring techniques, at least in the perioperative setting. This review describes the available techniques that currently are being used in the care of the cardiovascular patient and discusses their strengths and limitations. Even though the thermodilution method remains the gold standard for measuring cardiac output (CO), the use of the pulmonary artery catheter has declined over the last decades, even in the setting of cardiovascular anesthesia. The transpulmonary thermodilution method, in addition to accurately measuring CO, provides the user with some additional helpful variables, of which extravascular lung water is probably the most interesting. Less-invasive monitoring techniques use, for example, pulse contour analysis to originate flow-derived variables such as stroke volume and CO from the arterial pressure signal, or they may measure the velocity-time integral in the descending aorta to estimate the stroke volume, using, for example, the esophageal Doppler. Completely noninvasive methods such as the volume clamp method use finger cuffs to reconstruct the arterial pressure waveform, from which stroke volume and CO are calculated. All of these less-invasive CO monitoring devices have percentage errors around 40% compared with reference methods (thermodilution), meaning that the values are not interchangeable.

Roberts, W. C., A. Y. Lee, S. R. Lander, C. S. Roberts and B. L. Hamman (2019). “Libman-Sacks Endocarditis Involving a Bioprosthesis in the Aortic Valve Position in Systemic Lupus Erythematosus.” Am J Cardiol 124(2): 316-318.

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Described herein is a 39-year-old man with systemic lupus erythematosus not receiving corticosteroid therapy who developed Libman-Sacks endocarditis causing stenosis of a bioprosthesis in the aortic valve position.