Baylor Research Institute

Shahbazov, R., B. Naziruddin, K. Yadav, G. Saracino, G. Yoshimatsu, M. A. Kanak, E. Beecherl, P. T. Kim and M. F. Levy (2017). “Risk factors for early readmission after total pancreatectomy and islet auto transplantation.” HPB (Oxford): 1-9.

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BACKGROUND: Little published data exist examining causes of hospital readmission following total pancreatectomy with islet autotransplantation (TPIAT). METHODS: A retrospective analysis was performed of a prospectively collected institutional TPIAT database. Primary outcome was unplanned readmission to the hospital within 30 days from discharge. Reasons and risk factors for readmission as well as islet function were evaluated and compared by univariate and multivariate analysis. RESULTS: 83 patients underwent TPIAT from 2006 to 2014. 21 patients (25.3%) were readmitted within 30 days. Gastrointestinal problems (52.4%) and surgical site infection (42.8%) were the most common reasons for readmission. Initial LOS and reoperation were risk factors for early readmission. Patients with delayed gastric emptying (DGE) were three times more likely to get readmitted. In multivariate analysis, patients undergoing pylorus preservation surgery were nine times more likely to be readmitted than the antrectomy group. CONCLUSION: Early readmission after TPIAT is common (one in four patients), underscoring the complexity of this procedure. Early readmission is not detrimental to islet graft function. Patients undergoing pylorus preservation are more likely to get readmitted, perhaps due to increased incidence of delayed gastric emptying. Decision for antrectomy vs. pylorus preservation needs to be individualized.

Schiattarella, G. G., A. Sannino, E. Toscano, G. Giugliano, G. Gargiulo, A. Franzone, B. Trimarco, G. Esposito and C. Perrino (2017). “Gut microbe-generated metabolite trimethylamine-n-oxide as cardiovascular risk biomarker: A systematic review and dose-response meta-analysis.” Eur Heart J 38(39): 2948-2956.

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Aims: Gut microbiota-derived metabolite trimethylamine-N-oxide (TMAO) is emerging as a new potentially important cause of increased cardiovascular risk. The purpose of this meta-analysis was to systematically estimate and quantify the association between TMAO plasma levels, mortality, and major adverse cardio and cerebrovascular events (MACCE). Methods and results: MEDLINE, ISI Web of Science, and SCOPUS databases were searched for ad hoc studies published up to April 2017. Associations between TMAO plasma levels, all-cause mortality (primary outcome) and MACCE (secondary outcome) were systematically addressed. A total of 17 clinical studies were included in the analytic synthesis, enrolling 26 167 subjects. The mean follow-up in our study population was 4.3 +/- 1.5 years. High TMAO plasma levels were associated with increased incidence of all-cause mortality [14 studies for 16 cohorts enrolling 15 662 subjects, hazard ratio (HR): 1.91; 95% confidence interval (CI): 1.40-2.61, P < 0.0001, I2 = 94%] and MACCE (5 studies for 6 cohorts enrolling 13 944 subjects, HR: 1.67, 95% CI: 1.33-2.11, P < 0.00001, I2 = 46%,). Dose-response meta-analysis revealed that the relative risk (RR) for all-cause mortality increased by 7.6% per each 10 mumol/L increment of TMAO [summary RR: 1.07, 95% CI (1.04-1.11), P < 0.0001; based on seven studies]. Association of TMAO and mortality persisted in all examined subgroups and across all subject populations. Conclusions: This is the first systematic review and meta-analysis demonstrating the positive dose-dependent association between TMAO plasma levels and increased cardiovascular risk and mortality.

Douglas, P. S., M. B. Leon, M. J. Mack, L. G. Svensson, J. G. Webb, R. T. Hahn, P. Pibarot, N. J. Weissman, D. C. Miller, S. Kapadia, H. C. Herrmann, S. K. Kodali, R. R. Makkar, V. H. Thourani, S. Lerakis, A. M. Lowry, J. Rajeswaran, M. T. Finn, M. C. Alu, C. R. Smith and E. H. Blackstone (2017). “Longitudinal hemodynamics of transcatheter and surgical aortic valves in the partner trial.” JAMA Cardiol: 2017 Sep [Epub ahead of print].

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Importance: Use of transcatheter aortic valve replacement (TAVR) for severe aortic stenosis is growing rapidly. However, to our knowledge, the durability of these prostheses is incompletely defined. Objective: To determine the midterm hemodynamic performance of balloon-expandable transcatheter heart valves. Design, Setting, and Participants: In this study, we analyzed core laboratory-generated data from echocardiograms of all patients enrolled in the Placement of Aortic Transcatheter Valves (PARTNER) 1 Trial with successful TAVR or surgical AVR (SAVR) obtained preimplantation and at 7 days, 1 and 6 months, and 1, 2, 3, 4, and 5 years postimplantation. Patients from continued access observational studies were included for comparison. Interventions: Successful implantation after randomization to TAVR vs SAVR (PARTNER 1A; TAVR, n = 321; SAVR, n = 313), TAVR vs medical treatment (PARTNER 1B; TAVR, n = 165), and continued access (TAVR, n = 1996). Five-year echocardiogram data were available for 424 patients after TAVR and 49 after SAVR. Main Outcomes and Measures: Death or reintervention for aortic valve structural indications, measured using aortic valve mean gradient, effective orifice area, Doppler velocity index, and evidence of hemodynamic deterioration by reintervention, adverse hemodynamics, or transvalvular regurgitation. Results: Of 2795 included patients, the mean (SD) age was 84.5 (7.1) years, and 1313 (47.0%) were female. Population hemodynamic trends derived from nonlinear mixed-effects models showed small early favorable changes in the first few months post-TAVR, with a decrease of -2.9 mm Hg in aortic valve mean gradient, an increase of 0.028 in Doppler velocity index, and an increase of 0.09 cm2 in effective orifice area. There was relative stability at a median follow-up of 3.1 (maximum, 5) years. Moderate/severe transvalvular regurgitation was noted in 89 patients (3.7%) after TAVR and increased over time. Patients with SAVR showed no significant changes. In TAVR, death/reintervention was associated with lower ejection fraction, stroke volume index, and aortic valve mean gradient up to 3 years, with no association with Doppler velocity index or valve area. Reintervention occurred in 20 patients (0.8%) after TAVR and in 1 (0.3%) after SAVR and became less frequent over time. Reintervention was caused by structural deterioration of transcatheter heart valves in only 5 patients. Severely abnormal hemodynamics on echocardiograms were also infrequent and not associated with excess death or reintervention for either TAVR or SAVR. Conclusions and Relevance: This large, core laboratory-based study of transcatheter heart valves revealed excellent durability of the transcatheter heart valves and SAVR. Abnormal findings in individual patients, suggestive of valve thrombosis or structural deterioration, were rare in this protocol-driven database and require further investigation.

Pibarot, P., R. T. Hahn, N. J. Weissman, M. Arsenault, J. Beaudoin, M. Bernier, A. Dahou, O. K. Khalique, F. M. Asch, O. Toubal, J. Leipsic, P. Blanke, F. Zhang, R. Parvataneni, M. Alu, H. Herrmann, R. Makkar, M. Mack, R. Smalling, M. Leon, V. H. Thourani and S. Kodali (2017). “Association of paravalvular regurgitation with 1-year outcomes after transcatheter aortic valve replacement with the sapien 3 valve.” JAMA Cardiol: 2017 Sep [Epub ahead of print].

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Importance: Moderate/severe and even mild paravalvular regurgitation (PVR) are associated with increased mortality following transcatheter aortic valve replacement (TAVR) with first and second generations of transcatheter valves. Objective: To examine the incidence, evolution, and effect on 1-year outcomes of PVR following TAVR with a third-generation balloon-expandable transcatheter heart valve. Design, Setting, and Participants: Prespecified analysis of PVR in the Placement of Aortic Transcatheter Valves (PARTNER) II SAPIEN 3 trial, conducted between October 1, 2013, and September 3, 2014. Multicenter, nonrandomized registry of 1661 patients at intermediate or high surgical risk undergoing TAVR with the SAPIEN 3. Patients with severe, symptomatic aortic stenosis and high/intermediate surgical risk were enrolled in the registry at 51 sites in the United States and Canada. Interventions: Transcatheter aortic valve replacement with the SAPIEN 3 valve. Main Outcomes and Measures: Paravalvular regurgitation was assessed in a core laboratory at 30 days and 1 year according to a 5-class scheme: 0, none or trace; 1, mild; 2, mild to moderate; 3, moderate; 4, moderate to severe; and 5, severe. We assessed the effect of PVR on 1-year mortality and heart failure rehospitalization. Results: Among the 1661 included in the registry, 1592 received a SAPIEN 3 valve and had assessment of PVR. Of these patients, 55.7% had none-trace PVR, 32.6% had mild, 8.2% had mild to moderate, and 3.5% had at least moderate PVR at 30 days. At 1 year, 9.3% of patients had died and 14.2% had been rehospitalized. Only patients with at least moderate PVR had higher 1-year mortality (hazard ratio [HR], 2.40; 95% CI, 1.30-4.43; P = .005) and composite of mortality/rehospitalization (HR, 2.35; 95% CI, 1.52-3.62; P < .001). In a paired comparison including 1213 patients, 73% of the patients with at least moderate PVR at 30 days showed a reduction in PVR severity of at least 1 PVR class at 1 year. Conclusions and Relevance: In this series of patients undergoing TAVR with the SAPIEN 3 valve, at least moderate PVR was rare but associated with increased risk of death and heart failure rehospitalization at 1 year. Even the upper range of the mild class in the 3-class grading scheme (ie, mild to moderate in the 5-class scheme) had no significant effect on short-term mortality or rehospitalization. Most patients with at least moderate PVR at 30 days showed a decrease of PVR severity grade at 1 year.

Palazzuoli, A., G. Ruocco, O. De Vivo, R. Nuti and P. A. McCullough (2017). “Prevalence of hyperuricemia in patients with acute heart failure with either reduced or preserved ejection fraction.” Am J Cardiol 120(7): 1146-1150.

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The relation between uric acid (UA) and heart failure has been described; however, there is little detail concerning acute heart failure (AHF) in patients with reduced versus preserved ejection fraction heart failure (HFrEF, HFpEF). We studied 324 consecutive AHF patients screened from interventional Diur-HF Trial (NCT01441245) from January 2011 to February 2016, and divided into HFrEF (EF <50%) and HFpEF (EF >/=50%). We defined hyperuricemia as serum UA >/=7.0 mg/dL in men and >/=6 mg/dL in women. Patients were followed up for 6 months after discharge. The primary outcome was heart failure hospitalization or death. Among 173 HFrEF and 151 HFpEF cases, hyperuricemia was found in 43% and 57%, respectively (p = 0.01). Hyperuricemia was also more frequent in women (74% vs 60%; p = 0.008), those with diabetes (39% vs 19%; p <0.001), hypertension (62% vs 43%; p = 0.001), and atrial fibrillation (48% vs 34%; p = 0.01). In patients with HFrEF, univariate analysis found that hyperuricemia (hazard ratio [HR] 1.48, 95% confidence interval [CI] 1.02 to 2.15; p = 0.04) and congestion score >/=3 (HR 2.83, 95% CI 1.52 to 5.28; p <0.001) were associated with the primary end point; after adjustment, only congestion score >/=3 (HR 2.08, 95% CI 1.06 to 4.10; p = 0.03) confirmed this trend. Conversely, in patients with HFpEF, hyperuricemia was the only significant predictor of the primary end point both in univariate (HR 2.25, 95% CI 1.44 to 3.50; p <0.001) and multivariate analyses (HR 2.38, 95% CI 1.32 to 4.28; p = 0.004). In conclusion, in AHF hyperuricemia is common in both in HFrEF and in HFpEF. In the HFpEF subgroup, hyperuricemia was the only independent predictor of heart failure hospitalization or death.