Baylor Heart and Vascular Institute

Lo, K. B., P. A. McCullough and J. Rangaswami (2020). “Antihypertensive drugs and risk of COVID-19?” Lancet Respir Med(Mar 26. pii: S2213-2600(20)30156-9. [Epub ahead of print]).

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We caution against indiscriminate discontinuation of ACEIs and ARBs in patients who rely on these drugs for treatment of heart failure and who, additionally, might benefit from the postulated positive effects during overwhelming infection with SARS-CoV-2. Discontinuation of ACEIs or ARBs is associated with readmission to hospital and mortality among patients with heart failure.8 A surge of admissions to hospital for heart failure because of indiscriminate cessation of these important agents could overload already burdened health-care systems with vulnerable patients and cause diagnostic problems in view of the range of symptoms shared between acute heart failure and COVID-19, such as cough and shortness of breath. (Excerpt from text, no abstract available.)

Cunningham, J. W., M. Vaduganathan, B. L. Claggett, M. R. Zile, I. S. Anand, M. Packer, F. Zannad, C. S. P. Lam, S. Janssens, P. S. Jhund, L. Kober, J. Rouleau, S. J. Shah, V. K. Chopra, V. C. Shi, M. P. Lefkowitz, M. F. Prescott, M. A. Pfeffer, J. J. V. McMurray and S. D. Solomon (2020). “Effects of Sacubitril/Valsartan on N-Terminal Pro-B-Type Natriuretic Peptide in Heart Failure With Preserved Ejection Fraction.” JACC Heart Fail Mar 26. pii: S2213-1779(20)30146-3. [Epub ahead of print].

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OBJECTIVES: The authors sought to evaluate the prognostic significance of baseline N-terminal pro-B-type natriuretic peptide (NT-proBNP), whether NT-proBNP modified the treatment response to sacubitril/valsartan, and the treatment effect of sacubitril/valsartan on NT-proBNP overall and in key subgroups. BACKGROUND: Sacubitril/valsartan reduces NT-proBNP in heart failure (HF) with both reduced and preserved ejection fraction (EF), but did not significantly reduce total HF hospitalizations and cardiovascular death compared with valsartan in patients with HF with preserved EF (HFpEF). METHODS: In the PARAGON-HF (Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction) trial, 4,796 patients with HFpEF and elevated NT-proBNP were randomized to sacubitril/valsartan or valsartan. NT-proBNP was measured at screening in all patients and at 5 subsequent times in >2,700 patients: before, between, and after sequential valsartan and sacubitril/valsartan run-in periods, and 16 and 48 weeks post-randomization. RESULTS: Median NT-proBNP was 911 pg/ml (interquartile range: 464 to 1,613 pg/ml) at screening. Screening NT-proBNP was strongly associated with the primary endpoint, total HF hospitalizations and cardiovascular death (rate ratio [RR]: 1.68 per log increase in NT-proBNP, 95% confidence interval [CI]: 1.53 to 1.85; p < 0.001). This relationship was stronger in patients with atrial fibrillation (adjusted RR: 2.33 [95% CI: 1.89 to 2.87] vs. 1.58 [95% CI: 1.42 to 1.75] in patients without atrial fibrillation; p interaction <0.001) and weaker in obese patients (adjusted RR: 1.50 [95% CI: 1.31 to 1.71] vs. 1.92 [95% CI: 1.70 to 2.17] in nonobese patients; p interaction <0.001). Screening NT-proBNP did not modify the treatment effect of sacubitril/valsartan compared with valsartan (p interaction = 0.96). Sacubitril/valsartan reduced NT-proBNP by 19% (95% CI: 14% to 23%; p < 0.001) compared with valsartan 16 weeks post-randomization, with similar reductions in men (20%) and women (18%), and in patients with left ventricular EF 57% (18%). Decreases in NT-proBNP predicted lower subsequent risk of the primary endpoint. CONCLUSIONS: Baseline NT-proBNP predicted HF events but did not modify the sacubitril/valsartan treatment effect in patients with HFpEF. Sacubitril/valsartan reduced NT-proBNP consistently in men and women, and in patients with lower or higher EF. (Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction [PARAGON-HF]; NCT01920711).

Bohm, M., K. Kario, D. E. Kandzari, F. Mahfoud, M. A. Weber, R. E. Schmieder, K. Tsioufis, S. Pocock, D. Konstantinidis, J. W. Choi, C. East, D. P. Lee, A. Ma, S. Ewen, D. L. Cohen, R. Wilensky, C. M. Devireddy, J. Lea, A. Schmid, J. Weil, T. Agdirlioglu, D. Reedus, B. K. Jefferson, D. Reyes, R. D’Souza, A. S. P. Sharp, F. Sharif, M. Fahy, V. DeBruin, S. A. Cohen, S. Brar and R. R. Townsend (2020). “Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial.” Lancet Mar 27. pii: S0140-6736(20)30554-7. [Epub ahead of print].

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BACKGROUND: Catheter-based renal denervation has significantly reduced blood pressure in previous studies. Following a positive pilot trial, the SPYRAL HTN-OFF MED (SPYRAL Pivotal) trial was designed to assess the efficacy of renal denervation in the absence of antihypertensive medications. METHODS: In this international, prospective, single-blinded, sham-controlled trial, done at 44 study sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK, and the USA, hypertensive patients with office systolic blood pressure of 150 mm Hg to less than 180 mm Hg were randomly assigned 1:1 to either a renal denervation or sham procedure. The primary efficacy endpoint was baseline-adjusted change in 24-h systolic blood pressure and the secondary efficacy endpoint was baseline-adjusted change in office systolic blood pressure from baseline to 3 months after the procedure. We used a Bayesian design with an informative prior, so the primary analysis combines evidence from the pilot and Pivotal trials. The primary efficacy and safety analyses were done in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT02439749. FINDINGS: From June 25, 2015, to Oct 15, 2019, 331 patients were randomly assigned to either renal denervation (n=166) or a sham procedure (n=165). The primary and secondary efficacy endpoints were met, with posterior probability of superiority more than 0.999 for both. The treatment difference between the two groups for 24-h systolic blood pressure was -3.9 mm Hg (Bayesian 95% credible interval -6.2 to -1.6) and for office systolic blood pressure the difference was -6.5 mm Hg (-9.6 to -3.5). No major device-related or procedural-related safety events occurred up to 3 months. INTERPRETATION: SPYRAL Pivotal showed the superiority of catheter-based renal denervation compared with a sham procedure to safely lower blood pressure in the absence of antihypertensive medications. FUNDING: Medtronic.

Vidic, A., J. E. Shuster, Z. D. Goff, A. Godishala, S. M. Joseph, J. T. Chibnall and P. J. Hauptman (2019). “Vasopressin antagonism for decompensated right-sided heart failure.” Int J Cardiol 274: 245-247.

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BACKGROUND: Targeted treatment for decompensated right heart failure (RHF) with or without left heart failure is lacking. Vasopressin antagonists (vaptans) may offer an option by increasing urine output and fluid mobilization when used in acute decompensated RHF without impacting blood pressure or renal function, both common complications of loop diuretics. METHODS AND RESULTS: We searched electronic medical records from 2 institutions over 4years for patients with RHF treated with vaptans. Urine output, creatinine, BUN and sodium, 1day pre- versus 1day post-vaptan initiation were compared. Baseline (admission) pre-vaptan values for patients with RHF who met inclusion criteria (n=112) were RAP, median (interquartile range)=19 (13-24) mmHg; cardiac index, mean+/-standard deviation=1.8+/-0.4L/min/m2; BNP, 1078 (523-1690) pg/ml; creatinine clearance of 51 (39-69) ml/min, BUN, 37 (26-54) mg/dl, and serum [Na+] 132 (126-135) mEq/L. Most patients (n=103/112) received intravenous inotrope (prior to vaptan, n=91). Overall length of stay was 27 (16-43) days. Vaptan treatment (90% tolvaptan, 10% conivaptan) was associated with increased 24h urine output, 1517 (906-2394) vs 2337 (1425-3744) mL, p=0.005, and [Na+], 127 (124-130) vs 130 (126-135) mEq/L, p=0.001, without significant change in Cr or BUN. Furosemide IV dose equivalent decreased or remained unchanged in 75% of patients at 24h and 64% at 72h compared to the 24h prior to vaptan use. CONCLUSION: Vaptans were associated with a significant increase in urine output and serum sodium with an apparent reduction or stabilization of furosemide equivalent dosing in the early treatment period in patients with decompensated RHF. Vaptans may offer a management option for patients failing conventional diuretic-based treatment.

Roberts, W. C., P. A. Grayburn and S. A. Hall (2018). “Complications of Radiofrequency Ablation for Supraventricular Tachycardia in the Wolff-Parkinson-White Syndrome Associated With Noncompaction Cardiomyopathy.” Am J Cardiol 121(11): 1442-1444.

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Described herein is a 52-year-old man with Wolff-Parkinson-White syndrome and noncompaction cardiomyopathy who underwent 4 sternotomies to correct complications of 3 ablation procedures (2 open) for recurring supraventricular tachycardia, mitral valve repair for a damaged mitral valve during the third radiofrequency ablation procedure, and finally orthotopic heart transplantation.