Cardiology

Garan, A.R., Kanwar, M., Thayer, K.L., Whitehead, E., Zweck, E., Hernandez-Montfort, J., Mahr, C., Haywood, J.L., Harwani, N.M., Wencker, D., Sinha, S.S., Vorovich, E., Abraham, J., O’Neill, W., Burkhoff, D. and Kapur, N.K. (2020). “Complete Hemodynamic Profiling With Pulmonary Artery Catheters in Cardiogenic Shock Is Associated With Lower In-Hospital Mortality.” JACC Heart Fail 8(11): 903-913.

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OBJECTIVES: The purpose of this study was to investigate the association between obtaining hemodynamic data from early pulmonary artery catheter (PAC) placement and outcomes in cardiogenic shock (CS). BACKGROUND: Although PACs are used to guide CS management decisions, evidence supporting their optimal use in CS is lacking. METHODS: The Cardiogenic Shock Working Group (CSWG) collected retrospective data in CS patients from 8 tertiary care institutions from 2016 to 2019. Patients were divided by Society for Cardiovascular Angiography and Interventions (SCAI) stages and outcomes analyzed by the PAC-use group (no PAC data, incomplete PAC data, complete PAC data) prior to initiating mechanical circulatory support (MCS). RESULTS: Of 1,414 patients with CS analyzed, 1,025 (72.5%) were male, and 494 (34.9%) presented with myocardial infarction; 758 (53.6%) were in SCAI Stage D shock, and 263 (18.6%) were in Stage C shock. Temporary MCS devices were used in 1,190 (84%) of those in advanced CS stages. PAC data were not obtained in 216 patients (18%) prior to MCS, whereas 598 patients (42%) had complete hemodynamic data. Mortality differed significantly between PAC-use groups within the overall cohort (p < 0.001), and each SCAI Stage subcohort (Stage C: p = 0.03; Stage D: p = 0.05; Stage E: p = 0.02). The complete PAC assessment group had the lowest in-hospital mortality than the other groups across all SCAI stages. Having no PAC assessment was associated with higher in-hospital mortality than complete PAC assessment in the overall cohort (adjusted odds ratio: 1.57; 95% confidence interval: 1.06 to 2.33). CONCLUSIONS: The CSWG is a large multicenter registry representing real-world patients with CS in the contemporary MCS era. Use of complete PAC-derived hemodynamic data prior to MCS initiation is associated with improved survival from CS.

Curcio, N., Bennett, M.M., Hebeler, K.R., Warren, A.M. and Edgerton, J.R. (2020). “Quality of Life Is Improved One Year Following Cardiac Surgery.” Ann Thorac Surg Oct 13;S0003-4975(20)31658-1. [Epub ahead of print].

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BACKGROUND: Quality of life (QoL) is increasingly important in the era of patient-centered outcomes and value-based reimbursement. However, most follow-up is limited to 30 days and long-term data on QoL improvement associated with symptom relief are lacking. Therefore, we sought to analyze QoL following cardiac surgery in a non-emergent, all-comers population. METHODS: A total of 402 patients undergoing routine cardiac surgery at two large urban hospitals in the Dallas, Texas area were enrolled. Follow-up was complete for 364 patients. Data was collected from 08/2013-01/2017. The Kansas City Cardiomyopathy Questionnaire (KCCQ) was administered at baseline, one month, and one year following surgery. Repeated measures analysis was used for each domain of the KCCQ for all procedures and stratified by procedure. If time was found to be a significant factor, pairwise analysis was performed with p-values adjusted using Tukey-Kramer method. RESULTS: There was a significant increase across all domains of KCCQ scores for all procedures and for most domains when stratifying by procedure. This increase in QoL is most marked after one month. All domain scores increased through one year except symptom stability which peaked at one month post-surgery and then regressed at one year, suggesting an overall improvement and stabilization of symptoms. The occurrence of complications did not alter this trajectory. CONCLUSIONS: QoL and other patient-centered outcomes are improved at one month and continue to improve throughout the year. Knowledge of these data is important for patient selection, fully informed consent and shared decision making.

Webb, J.G., Hensey, M., Szerlip, M., Schäfer, U., Cohen, G.N., Kar, S., Makkar, R., Kipperman, R.M., Spargias, K., O’Neill, W.W., Ng, M.K.C., Fam, N.P., Rinaldi, M.J., Smith, R.L., Walters, D.L., Raffel, C.O., Levisay, J., Latib, A., Montorfano, M., Marcoff, L., Shrivastava, M., Boone, R., Gilmore, S., Feldman, T.E. and Lim, D.S. (2020). “1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study.” JACC Cardiovasc Interv 13(20): 2344-2357.

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OBJECTIVES: The authors report the CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) expanded experience, 1-year outcomes, and analysis by functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR). BACKGROUND: The 30-day results from the CLASP study of the PASCAL transcatheter valve repair system for clinically significant mitral regurgitation (MR) have been previously reported. METHODS: Eligible patients had symptomatic MR ≥3+, were receiving optimal medical therapy, and were deemed candidates for transcatheter mitral repair by the local heart team. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days. Follow-up was continued to 1 year. RESULTS: One hundred nine patients were treated (67% FMR, 33% DMR); the mean age was 75.5 years, and 57% were in New York Heart Association functional class III or IV. At 30 days, there was 1 cardiovascular death (0.9%), MR ≤1+ was achieved in 80% of patients (77% FMR, 86% DMR) and MR ≤2+ in 96% (96% FMR, 97% DMR), 88% of patients were in New York Heart Association functional class I or II, 6-min walk distance had improved by 28 m, and Kansas City Cardiomyopathy Questionnaire score had improved by 16 points (p < 0.001 for all). At 1 year, Kaplan-Meier survival was 92% (89% FMR 96% DMR) with 88% freedom from heart failure hospitalization (80% FMR, 100% DMR), MR was ≤1+ in 82% of patients (79% FMR, 86% DMR) and ≤2+ in 100% of patients, 88% of patients were in New York Heart Association functional class I or II, and Kansas City Cardiomyopathy Questionnaire score had improved by 14 points (p < 0.001 for all). CONCLUSIONS: The PASCAL transcatheter valve repair system demonstrated a low complication rate and high survival, with robust sustained MR reduction accompanied by significant improvements in functional status and quality of life at 1 year. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study [CLASP]; NCT03170349).

Ather, N. and Roberts, W.C. (2020). “Location of the Cannula of the Left Ventricular Assist Device in Explanted Hearts After Orthotopic Heart Transplantation.” Am J Cardiol 134: 91-98.

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Many patients having orthotopic heart transplantation (OHT) have previously had a left ventricular assist device (LVAD). Such a scenario allows the study of the position of the LVAD cannula in the explanted heart. We studied the explanted hearts in 105 patients who had had a LVAD inserted earlier and later underwent OHT at Baylor University Medical Center from January 2005 to September 2019, and compared the patients in whom the margins of the LVAD cannula contacted the mural endocardium with those in whom it did not. The margins of the orifice of the LVAD cannula contacted the left ventricular (LV) mural endocardium in 38 (36%) patients (considered potentially hazardous insertion) whereas in 67 (64%) patients there was no contact (considered “ideal” insertion). Comparison of the patients with ideal cannular insertion to those with potentially hazardous insertion disclosed insignificant differences in age at LVAD insertion or OHT; gender; interval between the LVAD insertion and OHT; body mass index; underlying cardiac disease; whether or not the heart floated in a container of formaldehyde, and the type of LVAD inserted. The margins of the LVAD cannula contacted the LV mural endocardium significantly more in patients with smaller mean heart weights than those with larger mean heart weights. In conclusion, of the 105 patients studied, the cannula of the LVAD resided in the LV cavity at an angle that allowed the margins of the orifice of the cannula to contact the mural endocardium in 38 (36%), a situation that at least potentially could cause partial obstruction of its orifice. Nevertheless, comparison of the 38 patients with nonideal cannular insertion to the 67 with ideal cannular insertion disclosed only 1 significant difference between the 2 groups.

Yeoh, S.E., Dewan, P., Desai, A.S., Solomon, S.D., Rouleau, J.L., Lefkowitz, M., Rizkala, A., Swedberg, K., Zile, M.R., Jhund, P.S., Packer, M. and McMurray, J.J.V. (2020). “Relationship between duration of heart failure, patient characteristics, outcomes, and effect of therapy in PARADIGM-HF.” ESC Heart Fail Oct 19. [Epub ahead of print].

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AIMS: Little is known about patient characteristics, outcomes, and the effect of treatment in relation to duration of heart failure (HF). We have investigated these questions in PARADIGM-HF. The aim of the study was to compare patient characteristics, outcomes, and the effect of sacubitril/valsartan, compared with enalapril, in relation to time from HF diagnosis in PARADIGM-HF. METHODS AND RESULTS: HF duration was categorized as 0-1, >1-2, >2-5, and >5 years. Outcomes were adjusted for prognostic variables, including N-terminal pro-brain natriuretic peptide (NT-proBNP). The primary endpoint was the composite of HF hospitalization or cardiovascular death. The number of patients in each group was as follows: 0-1 year, 2523 (30%); >1-2 years, 1178 (14%); >2-5 years, 2054 (24.5%); and >5 years, 2644 (31.5%). Patients with longer-duration HF were older, more often male, and had worse New York Heart Association class and quality of life, more co-morbidity, and higher troponin-T but similar NT-proBNP levels. The primary outcome rate (per 100 person-years) increased with HF duration: 0-1 year, 8.4 [95% confidence interval (CI) 7.6-9.2]; >1-2 years, 11.2 (10.0-12.7); >2-5 years, 13.4 (12.4-14.6); and >5 years, 14.2 (13.2-15.2); P < 0.001. The hazard ratio was 1.26 (95% CI 1.07-1.48), 1.52 (1.33-1.74), and 1.53 (1.33-1.75), respectively, for >1-2, >2-5, and >5 years, compared with 0-1 year. The benefit of sacubitril/valsartan was consistent across HF duration for all outcomes, with the primary endpoint hazard ratio 0.80 (95% CI 0.67-0.97) for 0-1 year and 0.73 (0.63-0.84) in the >5 year group. For the primary outcome, the number needed to treat for >5 years was 18, compared with 29 for 0-1 year. CONCLUSIONS: Patients with longer-duration HF had more co-morbidity, worse quality of life, and higher rates of HF hospitalization and death. The benefit of a neprilysin inhibitor was consistent, irrespective of HF duration. Switching to sacubitril/valsartan had substantial benefits, even in patients with long-standing HF.