Cardiology

Thourani, V. H., J. Forcillo, N. Beohar, D. Doshi, R. Parvataneni, G. M. Ayele, A. J. Kirtane, V. Babaliaros, S. Kodali, C. Devireddy, W. Szeto, H. C. Herrmann, R. Makkar, G. Ailawadi, S. Lim, H. S. Maniar, A. Zajarias, R. Suri, E. M. Tuzcu, S. Kapadia, L. Svensson, J. Condado, H. A. Jensen, M. J. Mack and M. B. Leon (2016). “Impact of preoperative chronic kidney disease in 2,531 high-risk and inoperable patients undergoing transcatheter aortic valve replacement in the partner trial.” Ann Thorac Surg 102(4): 1172-1180.

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BACKGROUND: Although preoperative renal dysfunction (RD) is associated with increased mortality and morbidity after surgical aortic valve replacement, its impact on clinical outcomes after transcatheter aortic valve replacement (TAVR) is less defined. METHODS: TAVR patients in the PARTNER (Placement of Aortic Transcatheter Valves) trial with a calculable glomerular filtration rate (GFR) using the Modification of Diet in Renal Disease equation were included. Patients were divided into three groups: GFR >60 mL/min (none/mild RD), GFR 31 to 60 mL/min (moderate RD), and GFR

Suri, R. M., S. Minha, O. Alli, R. Waksman, C. S. Rihal, L. P. Satler, K. L. Greason, R. Torguson, A. D. Pichard, M. Mack, L. G. Svensson, J. Rajeswaran, A. M. Lowry, J. Ehrlinger, S. L. Mick, E. M. Tuzcu, V. H. Thourani, R. Makkar, D. Holmes, M. B. Leon and E. H. Blackstone (2016). “Learning curves for transapical transcatheter aortic valve replacement in the partner-i trial: Technical performance, success, and safety.” J Thorac Cardiovasc Surg 152(3): 773-780.

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OBJECTIVES: Introduction of hybrid techniques, such as transapical transcatheter aortic valve replacement (TA-TAVR), requires skills that a heart team must master to achieve technical efficiency: the technical performance learning curve. To date, the learning curve for TA-TAVR remains unknown. We therefore evaluated the rate at which technical performance improved, assessed change in occurrence of adverse events in relation to technical performance, and determined whether adverse events after TA-TAVR were linked to acquiring technical performance efficiency (the learning curve). METHODS: From April 2007 to February 2012, 1100 patients, average age 85.0 +/- 6.4 years, underwent TA-TAVR in the PARTNER-I trial. Learning curves were defined by institution-specific patient sequence number using nonlinear mixed modeling. RESULTS: Mean procedure time decreased from 131 to 116 minutes within 30 cases (P = .06) and device success increased to 90% by case 45 (P = .0007). Within 30 days, 354 patients experienced a major adverse event (stroke in 29, death in 96), with possibly decreased complications over time (P approximately .08). Although longer procedure time was associated with more adverse events (P < .0001), these events were associated with change in patient risk profile, not the technical performance learning curve (P = .8). CONCLUSIONS: The learning curve for TA-TAVR was 30 to 45 procedures performed, and technical efficiency was achieved without compromising patient safety. Although fewer patients are now undergoing TAVR via nontransfemoral access, understanding TA-TAVR learning curves and their relationship with outcomes is important as the field moves toward next-generation devices, such as those to replace the mitral valve, delivered via the left ventricular apex.

Schussler, J. M., A. Vasudevan, L. J. von Bose, J. I. Won and P. A. McCullough (2016). “Comparative efficacy of transradial versus transfemoral approach for coronary angiography and percutaneous coronary intervention.” Am J Cardiol 118(4): 482-488.

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Transradial artery (TRA) approach is associated with fewer vascular complications and reduced mortality in patients at high risk compared with transfemoral approach (TFA). The objective of our study was to compare the characteristics and outcomes of patients who had coronary angiography by TRA and TFA over the course of hospital implementation of this approach. We included 12,928 patients from Baylor University Medical Center and Baylor Heart and Vascular Hospital, Dallas, Texas, who underwent a coronary angiography from January 2008 to March 2015. To control for selection bias and the learning curve, a nested matched study design was used for patients with percutaneous coronary intervention (PCI) with TRA patients matched with TFA by age (+/-2 years) and calendar year of the procedure in a ratio of 1:3. TRA for PCI increased from nearly 0% in 2008 to 9% in 2014. Including patients from 2011 to 2015 for the analysis, patients with TFA were older (65 +/- 12 vs 64 +/- 11) and had lower mean body mass index (30 +/- 7 vs 33 +/- 9 kg/m(2)) than patients with TRA. Patients with TRA had less bleeding, dialysis, pseudoaneurysm, and access site hematomas than the patients with TRA (0.7% vs 0%; p = 0.02). By a conditional logistic regression, we observed fewer complications, readmissions, and in-hospital deaths among TRA patients than the matched TFA patients. In conclusion, patients undergoing angiography with/without PCI through TRA had fewer complications, readmissions, and a shorter length of hospital stay after procedure versus TFA at our hospital.

Packer, M. (2016). “The room where it happens: A skeptic’s analysis of the new heart failure guidelines.” J Card Fail 22(9): 726-730.

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New heart failure guidelines have been issued during the past several months, both in the United States and in Europe, in response to recent advances in and the approval of new drugs for the treatment of heart failure. Although guidelines documents are often viewed as authoritative and purely evidence-based, there are replete with meaningful (and inexplicable) inconsistencies, which derive from a review of the same body of scientific data by different groups. This satirical review highlights several examples of the entertaining foolishness of recent guideline documents in the good-natured hope that physicians will understand what the guidelines are, and more importantly, what they are not. Specifically, this paper describes the emergence of a new nonexistent disease; the strange battle between 2 bradycardic drugs (digoxin and ivabradine); the confusion that reigns over the positioning and dosing of inhibitors of the renin-angiotensin system; and the special recommendations that have been issued for certain special populations. As Otto von Bismarck remarked, guideline deliberations are like sausages; it is better not to see them being made. Yet, even after they are ready for public view, we should be cautious. Practitioners who rely on them for clinical decision-making engage in an unnecessary form of self-deception; those who read them literally and adhere to them strictly do not practice evidence-based medicine; and those who delve into them in a search for the truth are destined to be disappointed.

Messe, S. R. and M. J. Mack (2016). “Improving outcomes from transcatheter aortic valve implantation: Protecting the brain from the heart.” Jama 316(6): 587-588.

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In this issue of JAMA, Haussig and colleagues6 report the results of the CLEAN-TAVI study. This randomized clinical trial assessed the utility of an embolic protection device (the CLARET Montage Dual Filter System) designed for use in transcatheter aortic valve implantation (TAVI). Once deployed through the right brachial artery, this device uses 2 filters to cover 3 of the 4 cervicocephalic vessels, including both carotid arteries and the right vertebral artery, while the left vertebral artery remains unprotected. A total of 100 patients with severe aortic stenosis were randomized to undergo TAVI with (n = 50) or without (n = 50) the cerebral embolic protection device; the device was successfully placed in 92% of patients in the intervention group, with no device-related complications reported. The primary end point was the numerical difference in new postprocedure lesions in potentially protected brain territories detected on MRI at 2 days following TAVI.