Cardiology

Halaby, R., Herrmann, H.C., Gertz, Z.M., Lim, S., Kar, S., Lindenfeld, J., Abraham, W.T., Grayburn, P.A., Naidu, S., Asch, F.M., Weissman, N.J., Zhang, Y., Mack, M.J. and Stone, G.W. (2021). “Effect of Mitral Valve Gradient After MitraClip on Outcomes in Secondary Mitral Regurgitation: Results From the COAPT Trial.” JACC Cardiovasc Interv 14(8): 879-889.

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OBJECTIVES: The authors sought to evaluate the association between mean mitral valve gradient (MVG) and clinical outcomes among patients who underwent MitraClip treatment for secondary mitral regurgitation (SMR) in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial. BACKGROUND: In the COAPT trial, patients with heart failure (HF) and severe SMR who remained symptomatic despite guideline-directed medical therapy had marked 2-year reductions in mortality and HF hospitalizations after treatment with MitraClip. METHODS: MitraClip-treated patients were divided into quartiles (Q) based on discharge echocardiographic MVG (n = 250). Endpoints including all-cause mortality, HF hospitalization, and health status measures at 2 years were compared between quartiles. RESULTS: Mean MVG after MitraClip was 2.1 ± 0.4 mm Hg, 3.0 ± 0.2 mm Hg, 4.2 ± 0.5 mm Hg, and 7.2 ± 2.0 mm Hg in Q1 (n = 63), Q2 (n = 61), Q3 (n = 62), and Q4 (n = 64), respectively. There was no difference across quartiles in the 2-year composite endpoint of all-cause mortality or HF hospitalization (43.2%, 49.2%, 40.6%, and 40.9%, respectively; p = 0.80), nor in improvements in New York Heart Association functional class, Kansas City Cardiomyopathy Questionnaire score, or 6-min walk time. Results were similar after adjustment for baseline clinical and echocardiographic characteristics, post-procedure MR grade, and number of clips (all-cause mortality or HF hospitalization Q4 [44.6%] vs. Q1 to Q3 [40.3%]; adjusted hazard ratio: 1.23, 95% confidence interval: 0.60 to 2.51; p = 0.57). CONCLUSIONS: Among HF patients with severe SMR, higher MVGs on discharge did not adversely affect clinical outcomes following MitraClip. These findings suggest that in select patients with HF and SMR otherwise meeting the COAPT inclusion criteria, the benefits of MR reduction may outweigh the effects of mild-to-moderate mitral stenosis after MitraClip.

Gammie, J.S., Grayburn, P.A., Quinn, R.W., Hung, J. and Holmes, S.D. (2021). “Quantitating Mitral Regurgitation in Clinical Trials: The Need for a Uniform Approach.” Ann Thorac Surg.

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BACKGROUND: There is an established relationship between the degree of mitral regurgitation (MR) and prognosis. Quantitation of MR severity guides therapeutic approaches. Inconsistent definitions and categorization of MR severity in clinical studies limit meaningful comparisons between trials and compromise development of an effective evidence base. The purpose of this study was to quantify heterogeneity in grading systems for MR severity in the contemporary literature. METHODS: We performed a systematic review of randomized (RCT) and propensity score (PS) adjusted clinical studies of MV interventions (surgical or percutaneous). A total of 35 articles from 2015-2020 were included (15 RCT, 20 PS). RESULTS: There were 22 studies that reported MR severity in numerical categories, either values from the historical “plus” system or numerical MR grades, while 9 studies reported MR severity using text-only descriptive categories. Among the studies that used numerical categories, 2+ MR was defined as moderate in 64% of studies, mild in 27%, and mild-moderate in 9% and 3+ MR was defined as moderate in 14%, moderate-severe in 52%, and severe in 14%. CONCLUSIONS: There was substantial variability in MR severity definition and reporting in contemporary clinical studies of MV interventions. We recommend the historical “plus” numerical grading system be abandoned and that inclusion and outcome criteria in MR clinical trials be based on American and European guideline-recommended categories as none/trace, mild, moderate, and severe. Adoption of these simple recommendations will improve the consistency and quality of MR clinical trial design and reporting.

Edgerton, J.R. and Damiano, R.J., Jr. (2021). “Commentary: What is the measure of success for atrial fibrillation ablation? Is a reduction in arrhythmia burden sufficient?” J Thorac Cardiovasc Surg.

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In this issue of the Journal, Li and colleagues1 follow a small cohort of patients with paroxysmal atrial fibrillation (PAF) and previous cerebrovascular or peripheral thromboembolism, without previous intervention, who underwent stand-alone thoracoscopic pulmonary vein isolation and left atrial appendage excision. They compared these patients with a smaller group who opted for medical management. After controlling for CHA2DS2-VASc score (ie, congestive heart failure; hypertension; age ≥75 years; diabetes mellitus, stroke, or transient ischemic attack; vascular disease; age 65-74 years; sex category), the authors found that pulmonary vein isolation delayed progression of PAF. [No abstract; excerpt from Commentary].

Shih, E., Squiers, J.J. and DiMaio, J.M. (2021). “Systematic Review of Minimally Invasive Surgery for Mitral Valve Infective Endocarditis.” Innovations (Phila): 1556984521997086.

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OBJECTIVE: The scope of application of minimally invasive mitral valve surgery is expanding. However, the safety and efficacy of minimally invasive mitral valve surgery in the setting of infective endocarditis is not well known. We sought to identify the best evidence available to support a minimally invasive surgical approach for mitral valve infective endocarditis. METHODS: A systematic review of minimally invasive mitral valve surgery for infective endocarditis was conducted according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. RESULTS: A total of 6 manuscripts describing 271 patients were identified. Mean age was 60.4 ± 14.9 years old, and 60.1% patients were male. Mean EuroSCORE II was 24.6 ± 23.2. Mitral valve repair was achieved in 32.4% of cases. The average in-hospital mortality was 9.4%, and average length of hospital stay was 21.6 days. Survival was 89.1% at 30 days, and 1-year survival was 79.3%. Rate of conversion to sternotomy was 1.8%. Postoperative complications included: 6.9% postoperative bleeding, 9.3% new postoperative dialysis, 2.3% postoperative stroke, and 3.4% recurrence of endocarditis. Reoperation over the long-term was required in 9.3% of cases. CONCLUSIONS: Minimally invasive mitral valve surgery for infective endocarditis has acceptable perioperative morbidity as well as short- and intermediate-term mortality at experienced centers. Minimally invasive mitral valve surgery may be an acceptable alternative approach to infective endocarditis and warrants further study.

Al-Azizi, K.M., Idris, A., Christensen, J., Hamandi, M., Hale, S., Martits-Chalangari, K., Van Zyl, J.S., Ravindranathan, P., Banwait, J.K., McKracken, J., Smith, A., Apakama, G., Swim, J., Dolton, P., Chionh, K., Dimaio, M., Thomas, S., Szerlip, M., Sayfo, S., Dib, C., Mack, M. and Potluri, S. (2021). “Distal versus proximal radial artery access for cardiac catheterization and intervention: Design and rationale of the DIPRA trial.” Cardiovasc Revasc Med.

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BACKGROUND: Radial artery (RA) catheterization is the access of choice over femoral artery access for most interventional vascular procedures given its safety and faster patient recovery. There has been growing interest in distal radial artery (dRA) access as an alternative to the conventional proximal radial artery (pRA) access. Preserving the RA is important which serves as a potential conduit for future coronary artery bypass surgery, dialysis conduit or preserve the artery for future cardiovascular procedures. The dRA runs in close proximity to the radial nerve, which raises the concern of potential detrimental effects on hand function. STUDY DESIGN: The Distal versus Proximal Radial Artery Access for cardiac catheterization and intervention (DIPRA) trial is a prospective, randomized, parallel-controlled, open-label, single center study evaluating the outcomes of hand function and effectiveness of dRA compared to pRA access in patients undergoing cardiac catheterization. The eligible subjects will be randomized to dRA and pRA access in a (1:1) fashion. The primary end point is an evaluation of hand function at one and twelve months follow-up. Secondary end points include rates of access site hematoma, access site bleeding, other vascular access complications, arterial access success rate, and RA occlusion at one and twelve months follow up. CONCLUSION: Effects of dRA on hand function remains unknown and it’s use questionable in the presence of a widely accepted pRA. DIPRA trial is designed to determine the safety and effectiveness of dRA for diagnostic and interventional cardiovascular procedures compared to the standard of care pRA.