Cardiology

Grayburn, P. A., J. K. Oh, M. J. Reardon, J. J. Popma, G. M. Deeb, M. Boulware, J. Huang and R. C. Stoler (2018). “Effect of Baseline Aortic Regurgitation on Mortality in Patients Treated With Transcatheter or Surgical Aortic Valve Replacement (from the CoreValve US Pivotal Trial).” Am J Cardiol 122(9): 1527-1535.

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This study was performed to determine if baseline aortic regurgitation (AR) affects the deleterious effects of postprocedure paravalvular leak following transcatheter aortic valve implantation (TAVI). We evaluated the effect of baseline AR on mortality in a large cohort of patients randomized to transcatheter or surgical aortic valve replacement (SAVR). The analysis cohort comprised 739 patients who underwent attempted TAVI (n=386) or SAVR (n=353) in the CoreValve US Pivotal High Risk Trial and had baseline AR measurements. Patients were stratified by the severity of baseline AR into those with none and/or trace and those with >/=mild AR. Echocardiographic measurements were assessed by an independent core laboratory. Of the 386 TAVI patients, 204 (52.9%) had none and/or trace at baseline AR; 182 (47.2%) had >/=mild AR. Of the 353 SAVR patients, 169 (47.9%) had none and/or trace and 184 (52.1%) >/=mild AR. The presence of >/=mild baseline AR was associated with lower all-cause mortality at 1 year following TAVI (9.4% vs 18.6%, p=0.008) or SAVR (13.3% vs 24.4%, p=0.009). Mortality remained lower in the >/=mild baseline AR patients at 3 years after SAVR (p=0.011), but not TAVI. In conclusion, baseline AR appears to provide a protective effect on survival and quality of life in both TAVI and SAVR patients at 1 year; this effect persists out to 3 years in SAVR patients.

Giri, J. S., M. Szerlip, C. Devireddy, D. A. Cox, C. Kavinsky, P. Genereux, S. S. Naidu, C. Bruner, J. Struck, J. Kurz and J. Dunham (2018). “SCAI 2018 Think Tank Proceedings: “What should the role of the surgeon be in TAVR, both as a co-operator and in-patient evaluation for TAVR?” Catheter Cardiovasc Interv Oct 24. [Epub ahead of print].

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The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is held annually bringing together expert opinion from interventional cardiologists, administrative partners, and select members of the cardiovascular industry community in a collaborative venue . . . Over the past decade, transcatheter aortic valve replacement (TAVR) has been promulgated in the United States under unique circumstances; as a paradigm‐shifting procedure in which two operators from different specialties (interventional cardiology and cardiac surgery) are mandated to perform each case as “co‐surgeons” in order to receive Centers of Medicare and Medicaid Services (CMS) reimbursement for services. This is accomplished by a “mandated 62‐modifier”, which represents the CMS designation for a procedure performed by two operators entitling both to a total of 125% (ie, 62.5% each) of the professional fees assigned to the procedure by the CMS fee schedule. While use of 62‐modifiers is relatively common in a variety of complex procedures, TAVR is unique as the only procedure in which use of the 62‐modifer is mandated in all cases by CMS . . . While this has been the structure of TAVR evaluation and performance since its introduction to the US market, there have been tremendous advances in TAVR over the last decade, both related to technology and processes of care. Examples include: fully percutaneous access, moderate sedation, fast track protocols, dramatically reduced device profiles resulting in an overwhelming majority of cases being performed via transfemoral arterial access, and improvements in pacemaker and paravalvular leak rates. Nearly, all of these advances have served to make the procedure simpler, more consistent, and more efficient. Ongoing improvements in technology aim to further simplify the procedure allowing for rapid, accurate and consistent valve delivery by a single operator. These developments compelled us to re‐evaluate the appropriateness of the current system of care. [Four points of consensus from the SCAI discussions are described.] (Excerpt from text, p. 1-2.)

Feldman, T., R. Smith, 2nd and J. J. Popma (2018). “Primary MR remains undertreated.” Cardiovasc Revasc Med 2018 Oct 15. [Epub ahead of print].

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In their review, Wu et al. she light on contemporary practice for the management of severe primary mitral regurgitation (DMR) and validates other studies that show a large number of patients with this valve lesion do not undergo either repair surgery or catheter intervention. This observation is consistent with prior reports and suggests that undertreatment in recent experience remains problematic. Many patients do not meet criteria for surgery, or their MR may improve with medical therapy. In this report, the group categorized as “medical therapy” is not well described. Were they candidates for surgery, did they meet ACC guidelines criteria for surgery, or were they just not offered surgery? This heterogenous subset plus patients lost to followup appear to be the biggest underserved groups. Structured follow up is the essential. Potentially treating a reading of severe MR on an echo reading as a “critical lab value” that requires an action or specific dismissal would also be helpful. The multidisciplinary “heart team” is a class I indication for the evaluation of patients for TAVR and should be considered for patients with severe MR. Why do so many patients with a highly treatable valve lesion not find their way to therapy? The authors note that many were not referred for surgical consultation. The findings were based upon retrospective chart review so the basis for referral or non-referral could not be ascertained. There are clear reservations for referral of elderly patients for cardiac surgery, both among patients and many physicians, despite the potential for surgical repair, and in more recent practice for a variety of percutaneous repair and replacement options. This report spanned 2011–2016 and thus included only the early time frame after MitraClip approval for high risk patients with DMR in 2013. The use of MitraClip has increased rapidly since then and it would be useful to repeat this kind of analysis in more recent practice. Experience in some other institutions has been different. Goel et al. reported that only 16% of a large DMR cohort went without surgery, which may reflect referral bias or patient selection. The broader experience in US practice is also improving. Isolated primary mitral valve operations reported in the Society of Thoracic Surgeons Adult Cardiac Surgery Database have increased by 24% between 2011 and 2016. (From text of this commentary on S. Wu, et al. Incidence and treatment of severe primary mitral regurgitation in contemporary clinical practice Cardiovasc Revasc Med (2018) [in press].)

Lee, A. Y., K. M. Tecson, B. Lima, A. F. Shaikh, J. Collier, S. Still, R. Baxter, J. M. DiMaio, J. Felius, S. A. Carey, G. V. Gonzalez-Stawinski, R. Nauret, M. Wong, S. A. Hall and S. M. Joseph (2018). “Durable Left Ventricular Assist Device Implantation in Extremely Obese Heart Failure Patients.” Artif Organs Oct 25. [Epub ahead of print].

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BACKGROUND: Left ventricular assist devices (LVADs) have improved clinical outcomes and quality of life for those with end-stage heart failure. However, the costs and risks associated with these devices necessitate appropriate patient selection. LVAD candidates are becoming increasingly more obese and there are conflicting reports regarding obesity’s effect on outcomes. Hence, we sought to evaluate the impact of extreme obesity on clinical outcomes after LVAD placement. METHODS: Consecutive LVAD implantation patients at our center from June 2008- May 2016 were studied retrospectively. We compared patients with a body mass index (BMI) >/=40 kg/m(2) (extremely obese) to those with BMI <40 kg/m(2) with respect to patient characteristics and surgical outcomes, including survival. RESULTS: 252 patients were included in this analysis, 30 (11.9%) of whom met the definition of extreme obesity. We found that patients with extreme obesity were significantly younger (47[33, 57] v. 60[52, 67] years, p<0.001) with fewer prior sternotomies (16.7% v. 36.0%, p=0.04). They had higher rates of pump thrombosis (30% vs 9.0%, p=0.003) and stage 2/3 acute kidney injury (46.7% vs 27.0%, p=0.003), but there were no differences in 30-day or 1-year survival, even after adjusting for age and clinical factors. CONCLUSION: Extreme obesity does not appear to place LVAD implantation patients at a higher risk for mortality compared to those who are not extremely obese; however, extreme obesity was associated with an increased risk of pump thrombosis, suggesting that these patients may require additional care to reduce the need for urgent device exchange. This article is protected by copyright. All rights reserved.

Al-Azizi, K. M., V. Grewal, K. Gobeil, K. Maqsood, A. Haider, A. Mohani, G. Giugliano and A. S. Lotfi (2018). “The left distal trans-radial artery access for coronary angiography and intervention: A US experience.” Cardiovasc Revasc Med Oct 25. [Epub ahead of print].

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BACKGROUND: The radial artery is the access of choice in many catheterization labs around the world due to its proven benefits over the femoral artery access. There has been growing interest in the left radial artery. We sought to evaluate the feasibility, safety and complication rates of the left distal radial artery (ldTRA) access for cardiac catheterization. METHODS: This is a single arm retrospective study evaluating the feasibility and safety of performing cardiac catheterization through ldTRA. The procedure was completed using standard diagnostic and guiding catheters. Hemostasis was achieved with a radial band. Feasibility was the ability to cannulate the distal left radial artery as well as completing the procedure without requiring an additional arterial access. The safety point included hematoma, bleeding or neuropathy. RESULTS: ldTRA was attempted in 61 patients. 59 patients had successful completion of the procedure through ldTRA. Conversion occurred in 1 patient (1.7%), requiring an additional arterial access to complete the procedure. 34 patients (55.7%) required percutaneous coronary intervention (PCI). There was no access site bleeds post procedure, no hematomas, with 100% successful hemostasis with a radial hemostatic band. There were 2 cases requiring reaccess of the distal left radial artery access for repeat revascularization, with procedure success and good left radial artery patency. CONCLUSION: ldTRA is a safe and feasible arterial access in a radial experienced catheterization lab. ldTRA provides improved operator ergonomics and patient’s comfort, in addition to the advantage of being able to cannulate the bypass grafts and with a very low risk of vascular complications.