Michael J. Mack M.D.

Arnold, S. V., Y. Zhang, S. J. Baron, T. C. McAndrew, M. C. Alu, S. K. Kodali, S. Kapadia, V. H. Thourani, D. C. Miller, M. J. Mack, M. B. Leon and D. J. Cohen (2019). “Impact of Short-Term Complications on Mortality and Quality of Life After Transcatheter Aortic Valve Replacement.” JACC Cardiovasc Interv 12(4): 362-369.

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OBJECTIVES: The aim of this study was to examine the independent association of short-term complications of transcatheter aortic valve replacement (TAVR) with survival and quality of life at 1 year. BACKGROUND: Prior studies have examined the mortality and cost implications of various complications of TAVR. However, many of these complications may primarily affect patients’ quality of life after TAVR, which has not been previously studied. METHODS: Among patients at intermediate or high surgical risk who underwent TAVR as part of the PARTNER (Placement of Aortic Transcatheter Valve) 2 studies and survived 30 days, the association between complications within the 30 days after TAVR and mortality and quality of life at 1 year was examined. Quality of life was assessed using the Kansas City Cardiomyopathy Questionnaire and the Short-Form 12. Complications assessed included major and minor stroke, life-threatening and major bleeding, vascular injury, stage 3 acute kidney injury, new pacemaker implantation, and mild and moderate or severe paravalvular leak (PVL). Multivariable models that included all complications as well as baseline clinical factors were used to examine the independent association of each complication with outcomes. RESULTS: Among 3,763 TAVR patients, major stroke and stage 3 acute kidney injury were associated with markedly increased risk for 1-year mortality, with adjusted hazard ratios of 5.4 (95% confidence interval [CI]: 3.1 to 9.5) and 4.9 (95% CI: 2.7 to 8.8), respectively, as well as poorer quality of life among survivors (reductions in 1-year Kansas City Cardiomyopathy Questionnaire overall summary score of 15.1 points [95% CI: 24.8 to 5.3 points] and 14.7 points [95% CI: 25.6 to 3.8 points], respectively). Moderate or severe PVL, life-threatening bleeding, and major bleeding were each associated with a more modest increase in mortality and decrement in quality of life, whereas mild PVL was associated with a small decrease in quality of life. After adjusting for baseline characteristics and other complications, need for a new pacemaker, minor stroke, and vascular injury were not independently associated with poor outcomes. CONCLUSIONS: Among patients undergoing TAVR, similar events are associated with increased mortality and impaired quality of life at 1 year. These results suggest that despite considerable progress, efforts to further reduce stroke, acute kidney injury, bleeding, and moderate or severe PVL are likely to yield important clinical benefits and remain key targets for device iteration and procedural improvement.

Shahian, D. M., T. G. Gleason, R. J. Shemin, J. D. Carroll and M. J. Mack (2019). “TAVR 2.0: Professional Societies Collaborating to Measure, Assure, and Improve Quality.” Ann Thorac Surg 107(2): 329-330.

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The 2018 TAVR [transcatheter aortic valve replacement] Multisociety Expert Consensus Systems of Care Document is a remarkable paradigm of professional society cooperation to advance patient quality and safety. Written by representatives of the four relevant specialty organizations—the American Association for Thoracic Surgery, the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions, and The Society of Thoracic Surgeons (STS)—this document provides important recommendations that will sustain the steadily improving quality trajectory that has characterized this evolving field since the first Multisociety document was published in 2012 . . . Compared with the 2012 recommendations, this new document has stronger and more comprehensive requirements for quality and experience. TAVR quality measures include risk-adjusted in-hospital and 30-day mortality, and unadjusted 30-day neurologic events, vascular complications, bleeding, and aortic regurgitation (risk models are under development). In addition, there are plans to measure 1-year survival and patient-reported health status (Kansas City Cardiomyopathy Questionnaire [KCCQ]) and to develop 30-day and 1-year composite measures of mortality and morbidity. A STS/ACC Transcatheter Valve Therapy (TVT) Registry public reporting initiative is also planned. For surgical AVR (SAVR), perioperative outcomes and long-term durability have been extensively studied for almost 60 years. STS has implemented sophisticated composite performance measures for a variety of procedures, including AVR, and these are voluntarily publicly reported by 65% of adult cardiac programs. STS is planning to add 1-year KCCQ and survival status so that outcomes are fully comparable with those of TAVR. (Excerpt from text of this editorial, p. 329. Refers to article: Joseph E. Bavaria, et al. 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement, The Annals of Thoracic Surgery, Volume 107, Issue 2, February 2019, Pages 650-684.)

Sannino, A., S. Potluri, B. Pollock, G. Filardo, A. Gopal, R. C. Stoler, M. Szerlip, A. Chowdhury, M. J. Mack and P. A. Grayburn (2019). “Impact of Mitral Stenosis on Survival in Patients Undergoing Isolated Transcatheter Aortic Valve Implantation.” Am J Cardiol Jan 25. [Epub ahead of print].

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This study was performed to investigate the prevalence and impact on survival of baseline mitral stenosis (MS) in patients who underwent transcatheter aortic valve implantation (TAVI) due to the presence of severe symptomatic aortic stenosis. This retrospective study included 928 consecutive patients with severe, symptomatic aortic stenosis who underwent TAVI in 2 institutions, from January 2012 to August 2016. Mean follow-up was 40.8 +/- 13.9 months. Based on the mean mitral gradient (MMG) at baseline, 3 groups were identified: MMG <5 mm Hg (n=737, 81.7%); MMG >/=5 and <10 mm Hg (n=147, 16.3%); MMG >/=10 mm Hg (n=17, 1.9%). These latter were more frequently women, with a smaller body surface area, a higher prevalence of atrial fibrillation, chronic obstructive pulmonary disease, and previous history of coronary-artery bypass graft/percutaneous coronary intervention. At baseline, patients with MMG >/=10 mm Hg compared with >/=5 and <10 mm Hg and <5 mm Hg patients had a lower mitral valve area (2.4 +/- 0.94 vs 2.1 +/- 0.86 vs 1.5 +/- 0.44 cm(2)), a lower prevalence of MR >/=2+ (5.9% vs 28.6% and 15.6%, p <0.0001), a higher prevalence of severe mitral annular calcium (70.6% vs 45.6% and 13.0%, p <0.0001) and a higher systolic pulmonary arterial pressure (50.6 +/- 12.1 vs 47.2 +/- 14.5 and 41.6 +/- 14.4, p <0.0001). Despite the low prevalence of MMG >/=10 mm Hg, these patients had higher 5-year mortality compared with the other groups (adjusted hazard ratio 2.91, 95% confidence interval 1.17 to 7.20, p=0.02). In conclusion, severe calcific MS is uncommon in patients who underwent TAVI. Its presence is associated with higher long-term mortality whereas moderate MS is not.

Friedman, D. J., J. G. Gaca, T. Wang, S. C. Malaisrie, D. R. Holmes, J. P. Piccini, R. M. Suri, M. J. Mack, V. Badhwar, J. P. Jacobs, E. D. Peterson, S. C. Chow and J. Matthew Brennan (2019). “Use of left atrial appendage occlusion among older cardiac surgery patients with preoperative atrial fibrillation: a national cohort study.” J Interv Card Electrophysiol Feb 2. [Epub ahead of print].

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PURPOSE: Patients with atrial fibrillation (AF) undergoing cardiac surgery are at substantially increased risk for stroke. Increasing evidence has suggested that surgical left atrial appendage occlusion (S-LAAO) may have the potential to substantially mitigate this stroke risk; however, S-LAAO is performed in a minority of patients with AF undergoing cardiac surgery. We sought to identify factors associated with usage of S-LAAO. METHODS: In a nationally-representative, contemporary cohort (07/2011-06/2012) of older patients undergoing cardiac surgery with preoperative AF (n = 11,404) from the Medicare-linked Society of Thoracic Surgeons Adult Cardiac Surgery Database, we evaluated patient and hospital characteristics associated with S-LAAO use by employing logistic and linear regression models. RESULTS: In this cohort (average age, 76 years; 39% female), 4177 (37%) underwent S-LAAO. Neither S-LAAO nor discharge anticoagulation was used in 25% (“unprotected” patients). The overall propensity for S-LAAO decreased significantly with increasing CHA2DS2-VASc (congestive heart failure; hypertension; age 75 years or older; diabetes mellitus; stroke, transient ischemic attack, or thromboembolism; vascular disease; age 65 to 74 years; sex category (female)) score (ptrend < 0.001). There was substantial variability in S-LAAO use across geographic regions, and S-LAAO was more commonly performed at academic and higher-volume valve surgery centers. CONCLUSIONS: Substantial variability in use of S-LAAO exists. In many instances, the procedure is being deferred in the patients that may be poised to benefit the most (i.e., those with increased CHA2DS2-VASc score-defined stroke risk).

Dehmer, G. J., R. G. Brindis, D. M. Shahian and M. J. Mack (2019). “Challenges of Measuring and Assuring Quality for Transcatheter Aortic Valve Replacement.” J Am Coll Cardiol 73(3): 336-339.

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On July 25, 2018, the U.S. Centers for Medicare and Medicaid Services (CMS) convened a meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to examine whether there is sufficient scientific evidence to support specific procedure volume requirements for hospitals and heart team members to begin or maintain transcatheter aortic valve replacement (TAVR) programs. The meeting was organized for experts to make recommendations to CMS in anticipation of a new National Coverage Determination for TAVR to replace the original determination published in May 2012. MEDCAC panels do not make coverage determinations because that authority rests solely with CMS, but CMS considers their advice and the total body of information collected at the meeting. Three topics were common in many of the presentations, public comments, and deliberations of the committee: 1) the benefits, challenges and unintended consequences resulting from procedural volume requirements; 2) understanding the relationship between procedure volume and outcome; and 3) the challenge of measuring outcome when procedural volumes (sample sizes) are small. Assessing the overall ability of a center to treat aortic valve disease optimally involves not only TAVR but also surgical aortic valve replacement (SAVR) and, to a lesser extent, percutaneous coronary intervention (PCI). SAVR is the surgical alternative to TAVR and is occasionally required to deal with life-threatening TAVR complications. PCI is sometimes performed before TAVR or may be required on an emergency basis to correct a serious complication developing during TAVR. The relationship between TAVR and SAVR procedure volume, outcome, and quality is a specific example of the broader issue facing the U.S. health care system. As our health care system moves from one based on quantity and fee-for-service to one based more on quality and accountability for patients’ outcomes, determining what constitutes quality medical care and how to measure it will continue to increase in importance. (Excerpt from text, p. 337; abstract not available.)