ABSTRACT
INTRODUCTION: A systematic analysis of clinical trials was performed in order to assess the effectiveness and risks of bilateral renal denervation (RDN) in patients with chronic heart failure with reduced ejection fraction (HFrEF). METHODS: A systematic review was conducted of all clinical trials exploring the effectiveness of RDN in patients with HF who had reduced (<50%) EF. Primary outcomes were NYHA class, 6-min walk test, N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, left ventricular ejection fraction (LVEF) and other cardiac parameters including left ventricular end-systolic diameter (LVESD), left ventricular end-diastolic diameter (LVEDD), and left atrium diameter (LAD). Secondary outcomes were systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), glomerular filtration rate (GFR), and creatinine. RESULTS: Seven studies were included in this analysis. From baseline to 6 months after RDN, the pooled mean NYHA class was decreased (mean difference [MD], -0.9; 95% confidence interval [CI], -1.6 to -0.2; P = 0.018), the mean 6-min walk test was increased (MD, 79.5 m; 95% CI, 26.9 to 132.1; P = 0.003), and the average NT-proBNP level was decreased (MD, -520.6 pg/mL; 95% CI, -1128.4 to 87.2; P = 0.093). Bilateral RDN increased the LVEF (MD, 5.7%; 95% CI, 1.6 to 9.6; P = 0.004), decreased the LVESD (MD, -0.4 cm; 95% CI, -0.5 to -0.2; P < 0.001), decreased the LVEDD (MD, -0.5 cm; 95% CI, -0.6 to -0.3; P < 0.001), and decreased the LAD (MD, -0.4 cm; 95% CI, -0.8 to 0; P = 0.045). In addition, RDN significantly decreased systolic BP (MD, -9.4 mmHg; 95% CI, -16.3 to -2.4; P = 0.008) and diastolic BP (MD, -4.9 mmHg; 95% CI, -9.5 to -0.4; P = 0.033), and decreased HR (MD, -4.5 bpm; 95% CI, -8.2to -0.9; P = 0.015). RDN did not significantly change GFR (MD, 7.9; 95% CI, -5.0 to 20.8; P = 0.230), or serum creatinine levels (MD, -7.2; 95% CI, -23.7 to 9.4; P = 0.397). CONCLUSION: Bilateral RDN appears safe and well-tolerated in patients with HF. RDN improved the signs and symptoms of HF and slightly decreased systolic and diastolic BP without affecting renal function in the clinical trials performed to date.
ABSTRACT
OBJECTIVE(S): To evaluate complication rate and abandonment rate after tracheoesophageal puncture and to assess factors associated with these outcome measures. METHODS: Retrospective review of laryngectomy patients seen at a single academic institution between 1/1/2003 and 12/1/2018. Charts reviewed for demographics, medical comorbidities, tumor characteristics, surgical data, adjuvant treatment history, and complications related to laryngectomy or tracheoesophageal puncture. Complications were divided into minor and major. RESULTS: A total of 293 laryngectomees met inclusion criteria. Of these, 69 patients (23.5%) underwent tracheoesophageal puncture. Average follow up was 64.6 months (SD 58.3). Overall laryngectomy complication rate was 43.3%. Overall tracheoesophageal puncture complication rate was 73.9%, with 39.1% of patients having major complications and 34.8% having minor complications only. Total abandonment rate for tracheoesophageal puncture was 34.8%. No associations were seen between tracheoesophageal puncture complication or abandonment rates based on age, gender, race, or insurance status. An increased rate of laryngectomy complications was seen after primary tracheoesophageal puncture (76.5% vs 41.3%, P = .005). CONCLUSION: Tracheoesophageal puncture outcomes were similar in patients with varied demographic, medical, and treatment backgrounds. When considering timing, our findings suggest that patients should be counseled on the possibility of increased complication risk after primary tracheoesophageal puncture. In those in whom the surgeon already has concerns about wound healing, it may be prudent to avoid primary tracheoesophageal puncture. The relatively high abandonment rate emphasizes the value of this measure of tracheoesophageal puncture outcome and highlights the need for appropriate patient counseling and prospective studies assessing the decision to abandon.