Michael J. Mack M.D.

Sorajja, P., M. Mack, S. Vemulapalli, D. R. Holmes, Jr., A. Stebbins, S. Kar, D. S. Lim, V. Thourani, P. McCarthy, S. Kapadia, P. Grayburn, W. A. Pedersen and G. Ailawadi (2016). “Initial Experience With Commercial Transcatheter Mitral Valve Repair in the United States.” J Am Coll Cardiol 67(10): 1129-1140.

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BACKGROUND: Transcatheter mitral valve (MV) repair with the MitraClip received approval in 2013 for the treatment of prohibitive-risk patients with primary mitral regurgitation (MR). OBJECTIVES: The aim of this study was to report the initial U.S. commercial experience with transcatheter MV repair. METHODS: Data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with this percutaneous mitral valve repair device were analyzed. RESULTS: Of 564 patients (56% men, median age 83 years), severe symptoms were present in 473 (86.0%). The median Society of Thoracic Surgeons Predicted Risk of Mortality scores for MV repair and replacement were 7.9% (interquartile range: 4.7% to 12.2%) and 10.0% (interquartile range: 6.3% to 14.5%), respectively. Frailty was noted in 323 patients (57.3%). Transcatheter MV repair was performed for degenerative disease, present in 90.8% of patients. Overall, MR was reduced to grade

Baumgarten, H., J. J. Squiers, M. Arsalan, J. M. Dimaio and M. J. Mack (2016). “Defining the clinical need and indications: who are the right patients for transcatheter mitral valve replacement?” J Cardiovasc Surg (Torino). Mar 30. [Epub ahead of print]

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Mitral regurgitation (MR) can be divided into two major etiologies, primary and secondary MR. Primary MR, also termed degenerative or organic MR, is a disease of the valve itself and is treated routinely by surgical repair in all but prohibitive risk patients. In these patients, transcatheter repair techniques, including edge to edge repair with the MitraClip device have been largely successful and widely adopted. Transcatheter placement of artificial chords has also been performed. The potential role for transcatheter mitral valve replacement (TMVR) in primary MR will likely be quite limited. Secondary or functional MR is due to a disease of the left ventricle and not the valve itself. The MR is a result of dilation of the left ventricle causing distraction of the papillary muscles with tethering of the mitral leaflets and lack of leaflet coaptation. Medical therapy is the mainstay treatment, with resynchronization used in appropriate patients. Surgical repair, usually with an undersized annuloplasty, is used in a limited number of patients. Transcatheter edge to edge repair is used extensively outside the US in secondary MR and is the subject of a pivotal trial in the US. However, it is in this group of patients with secondary MR that there is the largest clinical unmet need and, hence, the greatest potential opportunity for transcatheter mitral valve replacement (TMVR). At least ten TMVR platforms are in early feasibility, first in human, or preclinical trial stages. Four devices have cumulative early human experience in <100 patients. In this article, we discuss those patients most likely to benefit from TMVR and detail lessons learned from the first human studies regarding patient selection.

Mack, M. and H. Baumgarten (2016). “Just because you get on a scale doesn’t mean you lose weight: is Meetbaar Beter really measurably better?” Eur J Cardiothorac Surg. 2016 Mar 16. [Epub ahead of print]

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The article by van Veghel et al.[First results of a national initiative to enable quality improvement of cardiovascular care by transparently reporting on patient-relevant outcomes; Eur J Cardiothorac Surg., first published online March 16, 2016] describes a national initiative in the Netherlands termed ‘Meetbaar Beter’ or in English ‘Measurably Better’. The stated goal of this multicentre effort according to its website ‘aims to improve quality and transparency of care for patients with heart diseases by measuring limited patient-relevant outcome measures’ (http://www.meetbaarbeter.com/). Those outcomes include survival, degree of health/recovery, time to recovery and return to normal activity, disutility of the care of treatment process, sustainability of health/recovery and nature of recurrences and long-term consequences of the therapy. By doing this, they are proposing to implement a ‘Value Based Healthcare Theory’ by ‘measuring patient relevant outcomes and sharing and adopting each others best practices.’ This programme that began in 2012, termed the Netherlands Joint Outcomes and Transparency Initiative is a voluntary cooperative of 14 of the 16 heart centres in the country. The initial results of that effort in 86 000 patients treated at 12 of those hospitals with one of three diseases are reported in the accompanying article. The conclusion of this study is that ‘annual data collection of patient relevant outcomes appears to be feasible’. Furthermore, the authors conclude that transparency drives quality improvement and that using a limited set of outcomes measures enables comparisons and ‘exposes the quality of decision-making’. Lastly, they conclude that transparent communication is feasible, safe, cost-effective and stimulates professional decision-making and disease management . . . While this is an ambitious national multicentre initiative that is based on achieving patient-centred healthcare value, it is not clear from this study exactly how much the ‘needle has moved’. It is also not apparent how much of any change that may have occurred is truly causation and not merely association. Don Berwick, former administrator of the Center for Medicare and Medicaid in the USA, has recently stated as the first of nine steps to improve healthcare that we must stop excessive measurement. Stated another way, just because you step on a scale does not mean you lose weight. While the goals of this programme are laudable and beyond reproach, the evidence that change is actually occurring is not evident from this report. We would encourage the leaders of this national initiative to make efforts to provide greater clarity of results actually achieved and quality improvement in patient-relevant outcomes that they can directly credit to the programme. They are stepping on the scales and weighing a lot but is any weight really being lost? (Excerpts from text; no abstract.)

Kodali, S., M. R. Williams, D. Doshi, R. T. Hahn, K. H. Humphries, V. T. Nkomo, D. J. Cohen, P. S. Douglas, M. Mack, K. Xu, L. Svensson, V. H. Thourani, E. M. Tuzcu, N. J. Weissman, M. Leon and A. J. Kirtane (2016). “Sex-Specific Differences at Presentation and Outcomes Among Patients Undergoing Transcatheter Aortic Valve Replacement: A Cohort Study.” Ann Intern Med 164(6): 377-384.

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BACKGROUND: Female sex is associated with poorer outcomes after surgical aortic valve replacement (SAVR). Data on sex-specific differences after transcatheter aortic valve replacement (TAVR) are conflicting. OBJECTIVE: To examine sex-specific differences in patients undergoing TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) trial. DESIGN: Secondary analysis of the randomized and nonrandomized portions of the PARTNER trial. (ClinicalTrials.gov: NCT00530894). SETTING: 25 hospitals in the United States, Canada, and Germany. PATIENTS: High-risk and inoperable patients (1220 women and 1339 men). INTERVENTION: TAVR. MEASUREMENTS: Demographic characteristics, cardiac and noncardiac comorbidities, mortality, stroke, rehospitalization, vascular complications, bleeding complications, and echocardiographic valve parameters. RESULTS: At baseline, women had lower rates of hyperlipidemia, diabetes, smoking, and renal disease but higher Society of Thoracic Surgeons Predicted Risk of Mortality scores (11.9% vs. 11.1%; P < 0.001). After TAVR, women had more vascular complications (17.3% vs. 10.0%; difference, 7.29 percentage points [95% CI, 4.63 to 9.95 percentage points]; P < 0.001) and major bleeding (10.5% vs. 7.7%; difference, 2.8 percentage points [CI, 0.57 to 5.04 percentage points]; P = 0.012) but less frequent moderate and severe paravalvular regurgitation (6.0% vs. 14.3%; difference, -8.3 percentage points [CI, -11.7 to -5.0 percentage points]; P < 0.001). At 30 days, the unadjusted all-cause mortality rate (6.5% vs. 5.9%; difference, 0.6 percentage point [CI, -1.29 to 2.45 percentage points]; P = 0.52) and stroke incidence (3.8% vs. 3.0%; difference, 0.8 percentage point [CI, -0.62 to 2.19 percentage points]; P = 0.28) were similar. At 1 year, all-cause mortality was significantly lower in women than in men (19.0% vs. 25.9%; hazard ratio, 0.72 [CI, 0.61 to 0.85]; P < 0.001). LIMITATION: Secondary analysis that included nonrandomized trial data. CONCLUSION: Despite a higher incidence of vascular and bleeding complications, women having TAVR had lower mortality than men at 1 year. Thus, sex-specific risk in TAVR is the opposite of that in SAVR, for which female sex has been shown to be independently associated with an adverse prognosis. PRIMARY FUNDING SOURCE: Edwards Lifesciences.

Biviano, A. B., T. Nazif, J. Dizon, H. Garan, J. Fleitman, D. Hassan, S. Kapadia, V. Babaliaros, K. Xu, R. Parvataneni, J. Rodes-Cabau, W. Y. Szeto, W. F. Fearon, D. Dvir, T. Dewey, M. Williams, M. J. Mack, J. G. Webb, D. C. Miller, C. R. Smith, M. B. Leon and S. Kodali (2016). “Atrial Fibrillation Is Associated With Increased Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement: Insights From the Placement of Aortic Transcatheter Valve (PARTNER) Trial.” Circ Cardiovasc Interv 9(1): e002766.

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BACKGROUND: This study sought to evaluate the impact of atrial fibrillation (AF) on clinical outcomes in patients undergoing transcatheter aortic valve replacement. METHODS AND RESULTS: Data were evaluated in 1879 patients with baseline and discharge ECGs who underwent transcatheter aortic valve replacement in the Placement of AoRTic TraNscathetER Valve (PARTNER) trial. A total of 1262 patients manifested sinus rhythm (SR) at baseline/SR at discharge, 113 SR baseline/AF discharge, and 470 AF baseline/AF discharge. Patients who converted from SR to AF by discharge had the highest rates of all-cause mortality at 30 days (P<0.0001 across all groups; 14.2% SR/AF versus 2.6% SR/SR; adjusted hazard ratio [HR]=3.41; P=0.0002) and over 2-fold difference at 1 year (P<0.0001 across all groups; 35.7% SR/AF versus 15.8% SR/SR; adjusted HR=2.14; P<0.0001). The presence of AF on baseline or discharge ECG was a predictor of 1-year mortality (adjusted HR=2.14 for SR/AF group and HR=1.88 for AF/AF groups; P<0.0001 for both groups versus SR/SR). For patients discharged in AF, those with lower ventricular response (ie, <90 bpm) experienced less 1-year all-cause mortality (HR=0.74; P=0.04). CONCLUSIONS: After transcatheter aortic valve replacement, the presence of AF at discharge, and particularly, the conversion to AF by discharge and higher ventricular response are associated with increased mortality. These data underscore the deleterious impact of AF, as well as the need for targeted interventions to improve clinical outcomes, in patients undergoing transcatheter aortic valve replacement. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.