Background— Off-label use of transcatheter aortic and pulmonary valve prostheses for tricuspid valve-in-valve implantation (TVIV) within dysfunctional surgical tricuspid valve (TV) bioprostheses has been described in small reports. Methods and Results— An international, multicenter registry was developed to collect data on TVIV cases. Patient-related factors, procedural details and outcomes, and follow-up data were analyzed. Valve-in-ring or heterotopic TV implantation procedures were not included. Data were collected on 156 patients with bioprosthetic TV dysfunction who underwent catheterization with planned TVIV. The median age was 40 years, and 71% of patients were in New York Heart Association class III or IV. Among 152 patients in whom TVIV was attempted with a Melody (n=94) or Sapien (n=58) valve, implantation was successful in 150, with few serious complications. After TVIV, both the TV inflow gradient and tricuspid regurgitation grade improved significantly. During follow-up (median, 13.3 months), 22 patients died, 5 within 30 days; all 22 patients were in New York Heart Association class III or IV, and 9 were hospitalized before TVIV. There were 10 TV reinterventions, and 3 other patients had significant recurrent TV dysfunction. At follow-up, 77% of patients were in New York Heart Association class I or II ( P <0.001 versus before TVIV). Outcomes did not differ according to surgical valve size or TVIV valve type. Conclusions— TVIV with commercially available transcatheter prostheses is technically and clinically successful in patients of various ages across a wide range of valve size. Although preimplantation clinical status was associated with outcome, many patients in New York Heart Association class III or IV at baseline improved. TVIV should be considered a viable option for treatment of failing TV bioprostheses.
Background Cardiac output (CO) is a useful measure of myocardial performance. CO monitoring is frequently performed in critically ill adults in order to guide physicians’ treatment strategies. However, standard methods of determining CO in children are not without risk and can be problematic secondary to their invasive nature and other technical problems. COstatus® system (Transonic Systems Inc, NY, USA), which is based on ultrasound dilution technology, works off in situ catheters and uses an innocuous indicator to allow for routine measurements of cardiac output and blood volumes in pediatric patients. The purpose of this study was to validate CO measured by COstatus® with those obtained by the clinical standard technique of pulmonary artery (PAC) thermodilution. Methods This was a prospective evaluation performed at a single institution. Any child with a structurally normal heart undergoing hemodynamic evaluation in the cardiac catheterization laboratory was included. A prograde right heart catheterization was performed, and CO was first determined by using the PAC thermodilution technique. Thermodilution results were then compared with CO measurements obtained using the COstatus system. The results were analyzed by standard correlation, Bland-Altman, and Crichtley and Critchley analyses. Results Twenty-eight patients were evaluated with a median age of 8 yrs and a median weight of 31 kg. The mean thermodilution cardiac index = 3.18 L/min (+/− 1.35 L/min), and the mean COstatus® cardiac index = 3.17 L/min (+/− 1.31 L/min). Standard Pearson correlation tests revealed an excellent correlation coefficient of 0.95 (p<0.0001). Bland-Altman analysis revealed good clinical agreement with a mean difference of −0.004 L/min with a precision of 0.8 L/min/ at 2 SD. A percentage error of 25.4% was noticed in this study which is less than the clinically acceptable limit. Conclusion The ultrasound dilution technique of determining CO using the COstatus® system provides a less invasive method than the traditional pulmonary artery thermodilution for accurately determining cardiac output in children. This is the first validation of the COstatus® system in pediatric patients. Further studies are required to establish its accuracy in pediatric patients with cardiac shunts and other hemodynamically unstable conditions.
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