Cardiology

Vader, J. M., D. H. Cooper and P. Rao (2018). “Re-Thinking Re-Synching in Left Ventricular Assist Device Recipients.” J Am Heart Assoc 7(12): June 15.

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In this issue of the Journal of the American Heart Association (JAHA), Gopinathannair et al provide meaningful clinical data to inform conjecture surrounding cardiac resynchronization therapy (CRT) and LVAD. This multicenter retrospective study is the largest published experience to date on the utility of CRT in patients with LVAD. A total of 488 continuous flow (CF)‐LVAD patients were studied, 265 with CRT‐D versus 223 with ICD alone. During a mean follow‐up of 620±509 days, no difference in mortality was seen between the CRT‐D group compared with the ICD‐only group (29% versus 25%, logrank P=0.28). In multivariate Cox regression, there was no evidence that CRT influenced survival (hazard ratio for mortality in patients with an ICD as opposed to CRT‐D 1.469 [95% confidence interval 0.859–2.514, P=0.16]). The only variable significantly associated with lower survival was amiodarone use (hazard ratio for mortality 1.77, P=0.01). In other unadjusted analyses, there were no significant differences between CRT‐D and ICD groups in terms of VA rates (43% versus 39%, P=0.3) or ICD shocks (35% versus 29%, P=0.2). All‐cause hospitalization rates were nonsignificantly lower in the CRT‐D group as opposed to the ICD group (0.46 per 100 days versus 0.59 per 100 days, P=0.06), while censoring at 1 year of follow‐up, there was a nonsignificant trend toward higher mortality in the CRT‐D group versus the ICD group (23% versus 15%, P=0.054). In the absence of statistical adjustment for baseline differences in covariates, particularly considering the older age of CRT patients, the meaning of these data is uncertain. Perhaps less ambiguous, the rate of generator changes was significantly higher in the CRT group compared with the ICD‐only group (26% versus 15.5%, P=0.003), though it was not reported whether this higher rate of generator changes contributed to more device infections, or anticoagulation‐related issues such as pocket hematomas or pump thrombosis. Retrospective, uncontrolled, observational data such as these have inherent limitations, but this article raises several important management questions. (Excerpt from text of this commentary, p. 2; no abstract available.)

Turagam, M. K., P. Velagapudi, S. Kar, D. Holmes, V. Y. Reddy, M. M. Refaat, L. Di Biase, A. Al-Ahmed, M. K. Chung, T. Lewalter, J. Edgerton, J. Cox Nu, J. Fisher, A. Natale and D. R. Lakkireddy (2018). “Cardiovascular Therapies Targeting Left Atrial Appendage.” J Am Coll Cardiol Jun 25. [Epub ahead of print].

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Left atrial appendage (LAA) closure has evolved as an effective strategy for stroke prevention in patients with atrial fibrillation who are considered suitable for oral anticoagulation. There is strong evidence based on randomized clinical trials with 1 percutaneous device, as well as a large registry experience with several devices, regarding the safety and efficacy of this strategy. In addition, there is encouraging data regarding the effect of epicardial LAA closure on decreasing arrhythmia burden and improvements in systemic homeostasis by neurohormonal modulation. However, there are several unresolved issues regarding optimal patient selection, device selection, management of periprocedural complications including device-related thrombus, residual leaks, and pericarditis. In this review, we summarize the rationale, evidence, optimal patient selection, and common challenges encountered with mechanical LAA exclusion.

Tang, G. H. L., S. Zaid, I. George, O. K. Khalique, Y. Abramowitz, Y. Maeno, R. R. Makkar, H. Jilaihawi, N. Kamioka, V. H. Thourani, V. Babaliaros, J. G. Webb, N. M. Htun, A. Attinger-Toller, H. Ahmad, R. Kaple, K. Sharma, J. A. Kozina, T. Kaneko, P. Shah, S. A. Hirji, N. D. Desai, S. Anwaruddin, D. Jagasia, H. C. Herrmann, S. S. Basra, M. A. Szerlip, M. J. Mack, M. Mathur, C. W. Tan, C. W. Don, R. Sharma, S. Gafoor, M. Zhang, S. R. Kapadia, S. L. Mick, A. Krishnaswamy, N. Amoroso, A. Salemi, S. C. Wong, A. S. Kini, J. Rodes-Cabau, M. B. Leon and S. K. Kodali (2018). “Impact of Aortic Root Anatomy and Geometry on Paravalvular Leak in Transcatheter Aortic Valve Replacement With Extremely Large Annuli Using the Edwards SAPIEN 3 Valve.” JACC Cardiovasc Interv Jun 26. [Epub ahead of print].

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OBJECTIVES: The aim of this study was to determine factors affecting paravalvular leak (PVL) in transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. BACKGROUND: The largest recommended annular area for the 29-mm S3 is 683 mm(2). However, experience with S3 TAVR in annuli >683 mm(2) has not been widely reported. METHODS: From December 2013 to July 2017, 74 patients across 16 centers with mean area 721 +/- 38 mm(2) (range: 684 to 852 mm(2)) underwent S3 TAVR. The transfemoral approach was used in 95%, and 39% were under conscious sedation. Patient, anatomic, and procedural characteristics were retrospectively analyzed. Valve Academic Research Consortium-2 outcomes were reported. RESULTS: Procedural success was 100%, with 2 deaths, 1 stroke, and 2 major vascular complications at 30 days. Post-dilatation occurred in 32%, with final balloon overfilling (1 to 5 ml extra) in 70% of patients. Implantation depth averaged 22.3 +/- 12.4% at the noncoronary cusp and 20.7 +/- 9.9% at the left coronary cusp. New left bundle branch block occurred in 17%, and 6.3% required new permanent pacemakers. Thirty-day echocardiography showed mild PVL in 22.3%, 6.9% moderate, and none severe. There was no annular rupture or coronary obstruction. Mild or greater PVL was associated with larger maximum annular and left ventricular outflow tract (LVOT) diameters, larger LVOT area and perimeter, LVOT area greater than annular area, and higher annular eccentricity. CONCLUSIONS: TAVR with the 29-mm S3 valve beyond the recommended range by overexpansion is safe, with acceptable PVL and pacemaker rates. Larger LVOTs and more eccentric annuli were associated with more PVL. Longer term follow-up will be needed to determine durability of S3 TAVR in this population.

Sathananthan, J., D. J. Murdoch, B. R. Lindman, A. Zajarias, W. A. Jaber, P. Cremer, D. Wood, R. Moss, A. Cheung, J. Ye, R. T. Hahn, A. Crowley, M. B. Leon, M. J. Mack and J. G. Webb (2018). “Implications of Concomitant Tricuspid Regurgitation in Patients Undergoing Transcatheter Aortic Valve Replacement for Degenerated Surgical Aortic Bioprosthesis: Insights From the PARTNER 2 Aortic Valve-in-Valve Registry.” JACC Cardiovasc Interv 11(12): 1154-1160.

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OBJECTIVES: The aim of this study was to assess the implications of concomitant tricuspid regurgitation (TR) in patients undergoing valve-in-valve (VIV) transcatheter aortic valve replacement. BACKGROUND: Patients undergoing VIV transcatheter aortic valve replacement with concomitant TR may have worse outcomes, and optimal management remains undetermined. METHODS: The multicenter PARTNER 2 (Placement of Aortic Transcatheter Valves) VIV trial enrolled patients with symptomatic degenerated surgical aortic bioprostheses who were at high risk for reoperation. Outcomes were assessed between patients with mild or no TR versus moderate or severe TR. RESULTS: A total of 237 patients underwent VIV procedures (mean age 78.7 +/- 10.8 years, mean Society of Thoracic Surgeons score 9.1 +/- 4.8%). In this cohort, 162 patients (68.4%) had mild or no TR, and 75 patients (31.6%) had moderate or severe TR. Although there was no difference in New York Heart Association functional class III or IV symptomatic status (89.3% vs. 91.4%; p = 0.62) or moderate or severe right ventricular dysfunction (9.4% vs. 16.9%; p = 0.11), patients with moderate or severe TR were more likely to be at high surgical risk, with a Society of Thoracic Surgeons score of >8 (62.7% vs 46.9%; p = 0.02). There was no difference in a composite endpoint of death and rehospitalization between moderate or severe TR and mild or no TR, either at 30 days (10.7% vs. 9.9%; p = 0.85) or at 1-year follow-up (24.1% vs. 23.2%; p = 0.80). There was a significant reduction in overall moderate or severe TR from baseline at 30 days (31.1% vs. 21.1%; p = 0.002), which was sustained at 1-year follow-up (38.0% vs. 22.8%; p = 0.004). CONCLUSIONS: Despite higher predicted surgical risk, the presence of TR was not a predictor of long-term outcomes. Importantly, there was significant reduction in TR severity at both short- and long-term follow-up. In selected patients undergoing VIV transcatheter aortic valve replacement, it may be appropriate to conservatively manage concomitant TR.

Packer, M. (2018). “Risk of heart failure in diabetic patients receiving sulfonylureas: reply.” Eur J Heart Fail 2018 Jun 11. [Epub ahead of print].

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Editors: I sincerely appreciate the comments of Vaccaro et al. regarding their experience in the TOSCA.IT trial. It seems clear that the TOSCA.IT investigators took specific steps to enroll a population of patients with type 2 diabetes, who were at low risk of developing heart failure during follow‐up. As a result, very few heart failure events were recorded in the trial, and consequently, the trial did not have adequate statistical power to determine if the risks of heart failure were truly similar in patients taking sulfonylureas and pioglitazone. In order to validly conclude that the two classes of drugs were associated with similar risks of heart failure, the TOSCA.IT trial would have had to record 10 times as many heart failure events. Given the low risk of the population that was studied, achievement of this target number of events would have required the enrolment of substantially more patients and a far longer period of follow‐up. Since this was not practical, the results of TOSCA.IT cannot provide reliable information concerning comparative risks of heart failure related to the use of sulfonylureas and pioglitazone. Even if additional data were to show that the increased risks of heart failure with sulfonylureas and pioglitazone were similar, it is important to worry about whether any increase in risk is acceptable, especially since certain antidiabetic medications (i.e. metformin and sodium–glucose co‐transporter 2 inhibitors) appear to reduce the risk of heart failure.1 Preventing heart failure and other macrovascular complications of diabetes is a critical goal of treatment. For most middle‐aged to elderly patients with type 2 diabetes, the heightened risk of macrovascular events is much greater and occurs much earlier than the risk of microvascular events. Furthermore, since risk reduction of macrovascular events is not clearly related to glycemic control, the appropriate choice of an antidiabetic medication must be determined not only by its effects to lower glycated hemoglobin but by its independent actions to reduce the risk of cardiovascular death, myocardial infarction and heart failure. (Full text of this letter; no abstract available.)