Prophylactic levosimendan did not result in a rate of the short-term composite end point of death, renal-replacement therapy, perioperative myocardial infarction, or use of a mechanical cardiac assist device that was lower than the rate with placebo among patients with a reduced left ventricular ejection fraction who were undergoing cardiac surgery with the use of cardiopulmonary bypass. (Funded by Tenax Therapeutics; LEVO-CTS ClinicalTrials.gov number, NCT02025621 .).
We conducted a prospective study in which 554 patients with chronic bifascicular and trifascicular conduction abnormalities were followed for an average of 42.4 +/- 8.5 months. Heart block occurred in 19 patients, and 17 were successfully treated. The actuarial five-year mortality from an event that could conceivably have been a bradyarrhythmia was 6 per cent (35 per cent from all causes). Of the 160 deaths 67 (42 per cent) were sudden; most of these were not ascribable to bradyarrhythmia but to tachyarrhythmia and myocardial infarction. Mortality was higher in patients with coronary-artery disease (P less than 0.01) and congestive heart failure (P less than 0.05). Patients in whom syncope developed before or after entry into the study had a 17 per cent incidence of heart block (2 per cent in those without syncope)(P less than 0.05); however, no single variable was predictive of which patients were at high risk of death from a bradyarrhythmia. The predictors of death were increasing age, congestive heart failure, and coronary-artery disease; the predictors of sudden death were coronary-artery disease and increasing age. The risks of heart block and of death from a bradyarrhythmia are low; in most patients, heart block can be recognized and successfully treated with a pacemaker.
Aortic valve replacement with or without concomitant procedures was performed using an allograft aortic valve in 534 patients. From December 1969 to May 1975 (group I), a 4°C stored valve was used (124 patients) and from June 1975 to July 1990 (group II), a cryopreserved valve (410 patients) was used. The 30‐day mortality was 8.9% (confidence limits [CL] 6.2%–12.3%) for group I and 2.7% (CL 1.9%‐3.8%) for group II. Actuarial patient survival including early hospital mortality at 14 years was 57% for group I and 71% for group II (p = 0.014). Actuarial freedom from thromboembolism for all patients (n = 534) was 94% at 14 years, and for patients who underwent isolated aortic valve replacement with or without coronary artery bypass graft (n = 457) was 97% at 14 years (p = 0.017). Actuarial freedom from allograft valve endocarditls at 14 years was 92% in group I and 94% in group II (p = 0.36). The actuarial freedom from moderate or severe allograft valve incompetence at 14 years was 50% (group I) and 78% (group II) (p = 0.27). Reoperation was undertaken for endocarditis, leaflet structural deterioration (SD), or technical reasons. The actuarial freedom from reoperation (all causes) at 14 years was 63% (group I) and 86% (group II) (p = 0.39). Reoperation for SD occurred in 34 patients in group I and three patients in group II. The actuarial freedom from reoperation for SD at 14 years was 67% (group I) and 95% (group II) (p = 0.001). To reflect a more accurate depiction of the prevalence of SD, patients were analyzed according to the development of “assumed structural deterioration” (at reoperation, at death with moderate or severe allograft valve incompetence and macroscopic valve deterioration on autopsy, and in the presence of moderate or severe allograft valve incompetence in patients not undergoing reoperation). The actuarial freedom from “assumed structural deterioration” at 14 years was 51% (group I) and 85% (group II) (p = 0.000003). The long‐term results confirm the low incidence of thromboembolism and endocarditis regardless of the method of preservation and demonstrate the overall acceptable performance of the viable cryopreserved allograft valve and its superiority over the 4°C stored valve.
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