Cardiology

McCullough, P. A., C. M. Ballantyne, S. K. Sanganalmath, G. Langslet, S. J. Baum, P. K. Shah, A. Koren, J. Mandel and M. H. Davidson (2018). “Efficacy and Safety of Alirocumab in High-Risk Patients With Clinical Atherosclerotic Cardiovascular Disease and/or Heterozygous Familial Hypercholesterolemia (from 5 Placebo-Controlled ODYSSEY Trials).” Am J Cardiol 121(8): 940-948.

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Patients with previous atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH) are at high risk of future cardiovascular events. Despite maximally tolerated doses of statins, many patients still have elevated low-density lipoprotein cholesterol (LDL-C) levels. We evaluated the efficacy and safety of alirocumab in patients with ASCVD and/or HeFH on a maximally tolerated dose of statin (rosuvastatin 20 or 40 mg, atorvastatin 40 or 80 mg, or simvastatin 80 mg, or lower doses with an investigator-approved reason) +/- other lipid-lowering therapies from 5 placebo-controlled phase 3 trials (52 to 78 weeks). Patients with (n = 2,449) and without (n = 1,050) ASCVD were pooled from the FH I, FH II, HIGH FH, LONG TERM, and COMBO I trials. Patients with HeFH with (n = 575) and without ASCVD (n = 682) were pooled from all trials except COMBO I. High-intensity statins were utilized in 55.7% to 59.0% and in 72.4% to 87.6% of the ASCVD and the HeFH groups, respectively. Efficacy end points included LDL-C percent change from baseline to week 24 stratified by alirocumab dose. Mean baseline demographics and lipid levels were comparable in alirocumab- and placebo-treated patients. LDL-C reductions from baseline at week 24 ranged from 46.6% to 51.3% for alirocumab 75/150 mg and from 54.1% to 61.9% for alirocumab 150 mg in ASCVD and HeFH groups and were sustained for up to 78 weeks. LDL-C reductions with alirocumab were independent of ASCVD and/or HeFH status (interaction p value >0.05). Concordant results were observed for other lipids analyzed. The overall safety in the subgroups analyzed was similar in both treatment arms. Injection-site reactions were observed more frequently with alirocumab versus placebo.

Mack, M. and M. Hamandi (2018). “Is it time for national systems of care for valvular heart disease?” EuroIntervention 13(18): e2109-e2111.

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There are new proposals posited in both Europe and the USA to create “systems of care” for diagnosing, managing and treating valve disease patients. The operating principle of both is to provide the right treatment, to the right patient, at the right time, while taking into account the patient’s wishes. Although this system of care concept is a relatively recent one for the management of patients with valvular heart disease, it is not a new concept in healthcare for the treatment of other diseases. Numerous examples exist in the USA that serve as precedent for a valve disease system of care. Starting in 1960, the National Cancer Institute in the USA created a highly successful nationwide three-tiered system for cancer care2. The American College of Surgeons in 1976 built a universally adopted four-tiered system of trauma centres. Likewise, national systems of care have been built for acute stroke management (Brain Attach Coalition), treatment of acute myocardial infarction (ACC/AHA door-to-balloon time programme) and bariatric surgery centres for patients with obesity. Building on the experience and lessons learned from the national programmes for management of these conditions, national systems of care for patients with valvular heart disease are being proposed in both Europe and the USA. A pilot programme for TAVI exists that gives some insight into how a system of care could work. In the Canadian province of British Columbia, a province-wide programmatic approach has been undertaken. There are four programmes performing TAVI in the province. They are linked together in a network in which three “primary valve centres” perform transfemoral TAVI while more complex patients with extensive comorbidities and/or needing alternative access approaches or valve-in-valve procedures are referred to a single advanced tertiary valve centre in Vancouver. Open lines of communication, readily available consultation and mentoring are maintained within the network. With TAVI, in which there is evidence for a “volume-outcome” relationship, they seem to have struck the right balance between maintaining optimal care while providing broad geographic patient access. So, can this concept of a valve network system of care be scaled to a national level? (Excerpt from text, p. e2110; no abstract available.)

Lima, B., O. Dur, J. Chuang, T. Chamogeorgakis, D. J. Farrar, K. S. Sundareswaran, J. Felius, S. M. Joseph, S. A. Hall and G. V. Gonzalez-Stawinski (2018). “Novel Cardiac Coordinate Modeling System for Three-Dimensional Quantification of Inflow Cannula Malposition of HeartMate II LVADs.” Asaio j 64(2): 154-158.

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Optimal function of left ventricular assist devices (LVADs) depends on proper alignment of the inflow cannula (IC). Quantitative guidelines for IC angulation are lacking because of variation in cardiac geometry and difficulty in analyzing three-dimensional (3D) cannula orientation relative to the left ventricle (LV). Based on contrast-enhanced computed tomography images from five normal and five clinically malpositioned IC cases in patients with HeartMate II LVADs, we developed a method for 3D quantification of IC malpositioning. Using Mimics image software (Materialise, Leuven, Belgium), the native heart, major arteries, and LVAD were segmented to create patient-specific 3D models, allowing LV cavity volume and long-axis length to be measured directly. The deviation of the IC was quantified in a cylindrical coordinate system at the IC insertion point relative to the mitral valve and septum, and IC occlusion was assessed by the distance between cannula inlet and the proximal endocardium. Compared with normal cases, patients with malpositioned pumps had shorter LV length (p = 0.03) and reduced pump pocket depth (p = 0.009). Malpositioned pumps may experience greater obstruction by the nearby myocardium. This quantitative 3D modeling tool may help identify different modes of pump malalignment and migration and may facilitate preoperative planning and minimally invasive approaches via virtual LVAD implantation.E

Khoynezhad, A., J. DelaRosa, M. R. Moon, W. T. Brinkman, R. B. Thompson, N. D. Desai, S. C. Malaisrie, L. N. Girardi, J. E. Bavaria and T. B. Reece (2018). “Facilitating Hemostasis After Proximal Aortic Surgery: Results of The PROTECT Trial.” Ann Thorac Surg 105(5): 1357-1364.

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BACKGROUND: This study intended to evaluate the safety and hemostatic efficacy of a novel vascular sealant (Tridyne; Neomend, Inc, Irvine, CA) compared with an accepted adjunctive hemostatic agent applied to aortotomy and sutures lines in cardiovascular operations. METHODS: Patients undergoing aortic valve replacement, ascending aortic replacement, or aortic root replacement were randomly assigned 2:1 to Tridyne (n = 107) or Gelfoam Plus (Baxter Healthcare Corp, Hayward, CA) (n = 51). These groups were similar with regard to age, sex, race, medical history, duration of bypass and cross-clamping, and number of suture lines treated. Suture lines were treated after confirmation of some leakage but before formal removal of the clamp. RESULTS: The median bleeding time was significantly lower for Tridyne versus Gelfoam Plus (0 versus 10.0 minutes, p < 0.0001). Immediate hemostasis was achieved in 59.4% of the Tridyne group versus 16.0% of Gelfoam Plus group (p < 0.0001). A significantly greater proportion of patients in the Tridyne group achieved successful hemostasis at the aortic suture line than patients in the Gelfoam Plus group (85.7% versus 40.0%, p < 0.0001). The Clinical Events Committee adjudicated 7 patients with possible device-related serious adverse events: 3 patients (2.9%) in the Tridyne group and 4 patients (8.2%) in the Gelfoam Plus group (p = 0.2097). CONCLUSIONS: Tridyne was safe and effective when used as an adjunct to conventional hemostasis to treat high-pressure vessels in patients who receive anticoagulation agents, in reducing time to hemostasis, and in promoting both immediate and persistent hemostasis.

Jabbour, R. J., A. Tanaka, A. Finkelstein, M. Mack, C. Tamburino, N. Van Mieghem, O. de Backer, L. Testa, P. Gatto, P. Purita, Z. Rahhab, V. Veulemans, A. Stundl, M. Barbanti, R. Nerla, J. M. Sinning, D. Dvir, G. Tarantini, M. Szerlip, W. Scholtz, S. Scholtz, D. Tchetche, F. Castriota, C. Butter, L. Sondergaard, M. Abdel-Wahab, H. Sievert, O. Alfieri, J. Webb, J. Rodes-Cabau, A. Colombo and A. Latib (2018). “Delayed Coronary Obstruction After Transcatheter Aortic Valve Replacement.” J Am Coll Cardiol 71(14): 1513-1524.

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BACKGROUND: Delayed coronary obstruction (DCO) is an uncommon and barely reported complication following transcatheter aortic valve replacement (TAVR). OBJECTIVES: The aim of this study was to describe the incidence and pathophysiological features of DCO after TAVR, obtained from a large international multicenter registry. METHODS: Data were retrospectively collected from an international multicenter registry consisting of 18 centers between November 2005 and December 2016. RESULTS: During the study period, 38 DCO (incidence 0.22%) cases were identified from a total of 17,092 TAVR procedures. DCO occurred more commonly after valve-in-valve procedures (0.89% vs. 0.18%; p < 0.001) and if self-expandable valves were used during the index procedure (0.36% vs. 0.11% balloon expandable; p < 0.01). DCO was most likely to occur /=60 days. The most frequent presentation was cardiac arrest (31.6%; n = 12), followed by ST-segment elevation myocardial infarction (23.7%; n = 9). The left coronary artery was obstructed in most cases (92.1%; n = 35). Percutaneous coronary intervention was attempted in the majority of cases (74.3% left main; 60% right coronary), and stent implantation was successful in 68.8%. The overall in-hospital death rate was 50% (n = 19), and was higher if DCO occurred