Fast versus ultra-slow thrombolytic infusion regimens in patients with obstructive mechanical prosthetic valve thrombosis: a pilot randomized clinical trial

Background Thrombolysis is an alternative to surgery for mechanical prosthetic valve thrombosis (MPVT). Randomized clinical trials have yet to test safety and efficacy of a proposed ultraslow thrombolytic infusion regimen. Methods and Results This single-center, open-label, pilot randomized clinical trial randomized adult patients with acute obstructive MPVT to an ultraslow thrombolytic regimen (25 mg of recombinant tissue-type plasminogen activator [rtPA] infused in 25h) and a fast thrombolytic regimen (50 mg of rtPA infused in 6h). If thrombolysis failed, a repeated dose of 25 mg of rtPA for 6h was administered in both groups up to a cumulative dose of 150 mg or the occurrence of a complication. Primary outcome was a complete MPVT resolution (>75% fall in the obstructive gradient by transthoracic echocardiography, <10° limitation in opening and closing valve motion angles by fluoroscopy, and symptom improvement). Key safety outcome was a BARC type III or V major bleeding. Overall, 120 patients, including 63 (52.5%) women, at a mean age of 36.3±15.3 years, were randomized. Complete thrombolysis success was achieved in 51 patients (85.0%) in the ultraslow-regimen group and 47 patients (78.3%) in the fast-regimen group (OR, 1.58; 95% CI, 0.25 to 1.63; P = 0.34). One case of transient ischemic attack and 3 cases of intracranial hemorrhage (absolute risk difference, −12.5%; 95% CI, −23.1% to −1.0%; P = 0.04). were observed only in the fast-regimen group. Conclusions The ultraslow thrombolytic regimen conferred a high thrombosis resolution rate without major complications. Such findings should be replicated in more adequately powered trials (IRCT20181022041406N2).

Prosthetic valves in the pulmonary position

In this thesis the prosthetic heart valve in the pulmonary position has been analyzed. The results in this thesis demonstrate that there is a need for a suitable valve for the pulmonary position, tailored to the physiological circumstances of the right ventricle and the young age of this population. Currently available valve types each have its own limitation that tend to be more prone in the pulmonary position. We have demonstrated that a mechanical prosthetic valve can be a suitable option for pulmonary valve replacement. furthermore, we have demonstrated that the hemodynamic conditions in which the valve is placed influence the functionality of valve. Our results showed that the quality of life of congenital heart disease patients with a prosthetic valve is comparable to the general population. Overall, we can conclude that the use of prosthetic valves in the pulmonary valve is suboptimal, while life expectancy increases and in particular the Quality of Life of patients with a pulmonary prosthetic valve does not seem to be affected.

Mechanical Prosthetic Valve Sparing for Aortic Root Abscess Complicated by Infective Endocarditis

Aortic root abscess complicated by infective endocarditis of a mechanical prosthetic valve is associated with morbidity and death. We retrospectively report our experience with a valve-sparing technique for managing this condition. From October 2014 through November 2017, 41 patients at our center underwent surgery for aortic root abscess complicated by infective endocarditis of a mechanical prosthetic valve. Twenty (48.7%) met prespecified criteria for use of our valve-sparing technique after careful assessment of the mechanical valve and surrounding tissues. Our technique involved draining the abscess, aggressively débriding all infected and necrotic tissues, and then repairing the resulting defect by suturing a Gelweave patch to the healthy aortic wall and to the cuff of the valve. We successfully preserved the mechanical aortic valve in all 20 patients. Two (10%) died early (≤30 d postoperatively) of low cardiac output syndrome with progressive heart failure, superadded septicemia, and multisystem organ failure. At 1-year follow-up, the 18 surviving patients (90%) were symptom free and had a well-functioning mechanical aortic valve with no paravalvular leak. We conclude that, in certain patients, our technique for managing aortic root abscess and sparing the mechanical aortic valve is a safe and less time-consuming approach with relatively low mortality and encouraging midterm follow-up outcomes.