scholarly journals A Novel Restorative Pulmonary Valve Conduit: Early Outcomes of Two Clinical Trials

2021 ◽  
Vol 7 ◽  
Author(s):  
David L. Morales ◽  
Cynthia Herrington ◽  
Emile A. Bacha ◽  
Victor O. Morell ◽  
Zsolt Prodán ◽  
...  

Objectives: We report the first use of a biorestorative valved conduit (Xeltis pulmonary valve–XPV) in children. Based on early follow-up data the valve design was modified; we report on the comparative performance of the two designs at 12 months post-implantation.Methods: Twelve children (six male) median age 5 (2 to 12) years and weight 17 (10 to 43) kg, had implantation of the first XPV valve design (XPV-1, group 1; 16 mm (n = 5), and 18 mm (n = 7). All had had previous surgery. Based on XPV performance at 12 months, the leaflet design was modified and an additional six children (five male) with complex malformations, median age 5 (3 to 9) years, and weight 21 (14 to 29) kg underwent implantation of the new XPV (XPV-2, group 2; 18 mm in all). For both subgroups, the 12 month clinical and echocardiographic outcomes were compared.Results: All patients in both groups have completed 12 months of follow-up. All are in NYHA functional class I. Seventeen of the 18 conduits have shown no evidence of progressive stenosis, dilation or aneurysm formation. Residual gradients of >40 mm Hg were observed in three patients in group 1 due to kinking of the conduit (n = 1), and peripheral stenosis of the branch pulmonary arteries (n = 2). In group 2, one patient developed rapidly progressive stenosis of the proximal conduit anastomosis, requiring conduit replacement. Five patients in group 1 developed severe pulmonary valve regurgitation (PI) due to prolapse of valve leaflet. In contrast, only one patient in group 2 developed more than mild PI at 12 months, which was not related to leaflet prolapse.Conclusions: The XPV, a biorestorative valved conduit, demonstrated promising early clinical outcomes in humans with 17 of 18 patients being free of reintervention at 1 year. Early onset PI seen in the XPV-1 version seems to have been corrected in the XPV-2, which has led to the approval of an FDA clinical trial.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02700100 and NCT03022708.

2019 ◽  
Vol 10 (2) ◽  
pp. 197-205 ◽  
Author(s):  
Chi Sum Yuen ◽  
Kwok Fai Lucius Lee ◽  
Inderjeet Bhatia ◽  
Nicholson Yam ◽  
Barnabe Antonio Rocha ◽  
...  

Background: Postcongenital heart surgery pulmonary regurgitation requires subsequent pulmonary valve replacement. We sought to compare the outcomes of pulmonary valve replacement after using bioprosthetic valves, porcine versus pericardial bioprosthesis. Method: Retrospective single-center study of consecutive pulmonary valve replacement in patients with pulmonary regurgitation following initial congenital cardiac surgery. From 2004 to 2016, 82 adult patients (53 males, 29 females) underwent pulmonary valve replacement at a mean age of 28.7 ± 8 years (range 18-52 years) with a mean time to pulmonary valve replacement of 24 ± 7 years (range 13-43 years). Porcine bioprosthetic valves (group 1, n = 32) and pericardial valves (group 2, n = 50) were used. Cardiac magnetic resonance imaging was performed (n = 54) at a mean of 18 ± 13 months before and 24 ± 21 months after pulmonary valve replacement. Results: No significant difference was seen between the groups except that the mean follow-up was longer for group 1 (5.02 ± 2.06 vs 4.08 ± 3.21 years). In-hospital mortality was 1.1%. Follow-up completeness was 100% with no late death. Mean right ventricular end-systolic and end-diastolic volumes reduced significantly in both the groups ( P < .001), whereas right ventricular ejection fraction remained unchanged (group 1, P = .129; group 2, P = .675) . Only the left ventricular end-diastolic volume increased in both the groups, but the increase was significant for group 2 only (group 1, P = .070; group 2, P = .015), whereas the left ventricular end-systolic and ejection fraction remained unchanged in both the groups. There was no reoperation for pulmonary valve replacement. Freedom from intervention was 93.8% (group 1) and 100% (group 2) at eight years after pulmonary valve replacement ( P = .407). Conclusion: Midterm outcomes of pulmonary valve replacement in our adult cohort were satisfactory. Both types of bioprosthetic valves performed comparably for eight years and were a good option in adults.


2020 ◽  
Author(s):  
Huan Liu ◽  
Jun Jin ◽  
Qiao Chen ◽  
Zhongmin Li

Abstract BackgroundThe incidence of thyroid nodules increased significantly, but the mortality rate of thyroid cancer remained stable or even decreased. However, surgical treatment of thyroid nodules is more aggressive, including the number and scope of surgery. the purpose of our study was to evaluate whether unilateral thyroid nodules affect the malignancy risk of contralateral thyroid nodules. Methods We conducted a retrospective study on all patients with thyroid nodules in a tertiary hospital within one year. Unilateral and bilateral thyroid nodules were the control group and the experimental group, respectively. Based on the TI-RADS grades, the experimental group and the control group were divided into two subgroups. We used chi-square test or Fisher's exact test to evaluate whether there were statistical differences in the incidence and pathological types of thyroid cancer between the experimental group and the control group. Results Our study showed that there was no significant difference in malignant risk between the experimental group 1 and the control group 1, and the experimental group 2 and the control group 2 (20%vs35%, p=0.724, 63.16%vs76.32%, p=0.297, respectively). Both the a-side thyroid of the experimental group and the control group were papillary thyroid carcinoma, including micropapillary thyroid carcinoma, and there was no difference in the proportion of micropapillary thyroid carcinoma (p = 0.200, 0.620, respectively). Conclusions There is no evidence that bilateral thyroid nodules affect each other in terms of malignant risk, that is, in bilateral thyroid nodules, unilateral thyroid cancer does not change the malignant risk of contralateral thyroid nodules.This study has been registered with the Chinese Clinical Trial Registry, clinical trial registration number: ChiCTR2000038611, registration time: 2020-09-26.


2017 ◽  
Vol 7 (2) ◽  
pp. 361-371 ◽  
Author(s):  
Jeremy A. Mazurek ◽  
Anjali Vaidya ◽  
Stephen C. Mathai ◽  
Justin D. Roberts ◽  
Paul R. Forfia

Few studies have examined the utility of serial echocardiography in the evaluation, management, and prognosis of patients with pulmonary arterial hypertension (PAH). Therefore, we sought to evaluate the prognostic significance of follow-up tricuspid annular plane systolic excursion (TAPSE) in PAH. We prospectively studied 70 consecutive patients with PAH who underwent baseline right heart catheterization (RHC) and transthoracic echocardiogram, who survived to follow-up echocardiogram after initiation of PAH therapy. Baseline TAPSE was 1.6 ± 0.5 cm which increased to 2.0 ± 0.4 cm on follow-up ( P < 0.0001). The cohort was dichotomized by TAPSE at one-year follow-up: Group 1 (n = 37): follow-up TAPSE ≥ 2 cm; Group 2 (n = 33): follow-up TAPSE < 2 cm. Group 1 participants were significantly more likely to reach WHO functional class I–II status and achieve a higher six-minute walk distance on follow-up. Of the 68 patients who survived more than one year, 18 died (26.5%) over a median follow-up of 941 days (range, 3–2311 days), with significantly higher mortality in Group 2 versus Group 1 (41.9% vs. 13.5%; P = 0.003). While baseline TAPSE stratified at 2 cm did not predict survival in this cohort, TAPSE ≥ 2 cm at follow-up strongly predicted survival in bivariable models (hazard ratio, 0.21; 95% confidence interval, 0.08–0.60). In conclusion, follow-up TAPSE ≥ 2 cm is a prognostic marker and potential treatment target in a PAH population.


Aorta ◽  
2017 ◽  
Vol 05 (05) ◽  
pp. 139-147 ◽  
Author(s):  
Andrea De Martino ◽  
Federico Re ◽  
Stefania Blasi ◽  
Michele Celiento ◽  
Giacomo Ravenni ◽  
...  

Background: Patients with annuloaortic ectasia may be surgically treated with modified Bentall or David I valve-sparing procedures. Here, we compared the long-term results of these procedures. Methods: A total of 181 patients with annuloaortic ectasia underwent modified Bentall (102 patients, Group 1) or David I (79 patients, Group 2) procedures from 1994 to 2015. Mean age was 62 ± 11 years in Group 1 and 64 ± 16 years in Group 2. Group 1 patients were in poorer health, with a lower ejection fraction and higher functional class. Results: Early mortality was 3% in Group 1 and 2.5% in Group 2. Patients undergoing a modified Bentall procedure had a higher incidence of thromboembolism and hemorrhage, whereas those undergoing a David I procedure had a higher incidence of endocarditis. Actuarial survival was 70 ± 6% at 15 years in Group 1 and 84 ± 7% at 10 years in Group 2. Actuarial freedom from reoperation was 97 ± 2% at 15 years in Group 1 and 84 ± 7% at 10 years in Group 2. In Group 2, freedom from procedure-related reoperations was 98 ± 2% at 10 years. At last follow-up, no cases of moderate or severe aortic regurgitation were observed. Conclusions: The modified Bentall and David I procedures showed excellent early and late results. The modified Bentall procedure with a mechanical conduit was associated with thromboembolic and hemorrhagic complications, whereas the David I procedure was associated with unexplained occurrences of endocarditis. Thus, the David I procedure appears to be safe, reproducible, and capable of achieving stable aortic valve repair and is therefore our currently preferred solution for patients with annuloaortic ectasia. However, the much shorter follow-up for David I patients limits the strength of our comparison between the two techniques.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Alegria ◽  
M J Loureiro ◽  
F Ferreira ◽  
R Cale ◽  
M Cabral ◽  
...  

Abstract Background To date, the first-line treatment for chronic thromboembolic pulmonary hypertension (CTEPH) is pulmonary endarterectomy (PEA), although a significant number of patients will have inoperable disease or residual pulmonary hypertension (PH). Balloon pulmonary angioplasty (BPA) has provided a new therapeutic option for these patients. In addition, medical therapy (MT) also plays an important role. Purpose Characterization of a population of patients with CTEPH or chronic thromboembolic disease (CTED) and comparison of the different treatment strategies according to the updated treatment algorithm. Methods Retrospective analysis of patients with CTEPH/CTED followed in a referral centre for the treatment of PH submitted to different treatment strategies: PEA plus MT and BPA in patients with residual PH (group 1), MT plus BPA (group 2), and MT only (group 3). Cox regression was used to identify predictors of all-cause mortality. Results 58 patients were included (median age 63.5 years, 74% female); 17% had CTED, and the remaining had CTEPH 50% (n=29) were submitted to PEA (group 1), of which 58% had residual PH (21% underwent BPA, n=3). Among the remaining patients, 31% (n=9) underwent MT plus BPA (group 2), and 69% (n=20) were treated with MT only (group 3). Overall, 55% were under pulmonary vasodilator therapy, including 38% with riociguat. Most of the patients (67%) were in functional class III or IV, the distance in the 6MWT was 328±147 meters, the median NT-proBNP was 538pg/ml, 40% had RV systolic dysfunction, the mean mPAP was 42±13 mmHg, and the mean PVR was 11±6 WU. Comparing the different treatment strategies, during follow-up (median 945 days) the following differences were found (comparison between group 1 vs group 2 vs group 3): improvement in functional class (class III-IV: 0% vs 0% vs 58%); distance in 6MWT (438±83 vs 390±79 vs 281±105 meters); evolution of NT-proBNP (−984±1736 vs −198±205 vs +1177±2342); normalization of RV dimensions (89% vs 50% vs 20%); resolution of pericardial effusion (100% vs 100% vs 0%); normalization of mPAP (73% vs 71% vs 0%); PVR (median 3.4 vs 2.7 vs 10.6 WU); all-cause mortality (7% vs 0% vs 35%) (p<0.02 in all). In the overall population, the most relevant predictors of all-cause mortality were the absence of functional class improvement, baseline and follow-up NT-proBNP, baseline and follow-up SPAP by echocardiogram, and maintenance of treatment with prostanoids (p<0.05 in all). Conclusion Our results confirm that, in patients with CTEPH/CTED, PEA is associated with functional, and hemodynamic improvement and increased survival, although BPA is an alternative in patients with inoperable disease or residual PH, with similar results on short-term follow-up. Patients who are not submitted to surgical or percutaneous intervention have a poor prognosis, both in terms of morbidity and mortality.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Proff ◽  
B Merkely ◽  
R Papp ◽  
C Lenz ◽  
P.J Nordbeck ◽  
...  

Abstract Background The prevalence of chronotropic incompetence (CI) in heart failure (HF) population is high and negatively impacts prognosis. In HF patients with an implanted cardiac resynchronisation therapy (CRT) device and severe CI, the effect of rate adaptive pacing on patient outcomes is unclear. Closed loop stimulation (CLS) based on cardiac impedance measurement may be an optimal method of heart rate adaptation according to metabolic need in HF patients with severe CI. Purpose This is the first study evaluating the effect of CLS on the established prognostic parameters assessed by the cardio-pulmonary exercise (CPX) testing and on quality of life (QoL) of the patients. Methods A randomised, controlled, double-blind and crossover pilot study has been performed in CRT patients with severe CI defined as the inability to achieve 70% of the age-predicted maximum heart rate (APMHR). After baseline assessment, patients were randomised to either DDD-CLS pacing (group 1) or DDD pacing at 40 bpm (group 2) for a 1-month period, followed by crossover for another month. At baseline and at 1- and 2-month follow-ups, a CPX was performed and QoL was assessed using the EQ-5D-5L questionnaire. The main endpoints were the effect of CLS on ventilatory efficiency (VE) slope (evaluated by an independent CPX expert), the responder rate defined as an improvement (decrease) of the VE slope by at least 5%, percentage of maximal predicted heart rate reserve (HRR) achieved, and QoL. Results Of the 36 patients enrolled in the study, 20 fulfilled the criterion for severe CI and entered the study follow-up (mean age 68.9±7.4 years, 70% men, LVEF=41.8±9.3%, 40%/60% NYHA class II/III). Full baseline and follow-up datasets were obtained in 17 patients. The mean VE slope and HRR at baseline were 34.4±4.4 and 49.6±23.8%, respectively, in group 1 (n=7) and 34.5±12.2 and 54.2±16.1% in group 2 (n=10). After completing the 2-month CPX, the mean difference between DDD-CLS and DDD-40 modes was −2.4±8.3 (group 1) and −1.2±3.5 (group 2) for VE slope, and 17.1±15.5% (group 1) and 8.7±18.8% (group 2) for HRR. Altogether, VE slope improved by −1.8±2.95 (p=0.31) in DDD-CLS versus DDD-40, and HRR improved by 12.9±8.8% (p=0.01). The VE slope decreased by ≥5% in 47% of patients (“responders to CLS”). The mean difference in the QoL between DDD-CLS and DDD-40 was 0.16±0.25 in group 1 and −0.01±0.05 in group 2, resulting in an overall increase by 0.08±0.08 in the DDD-CLS mode (p=0.13). Conclusion First results of the evaluation of the effectiveness of CLS in CRT patients with severe CI revealed that CLS generated an overall positive effect on well-established surrogate parameters for prognosis. About one half of the patients showed CLS response in terms of improved VE slope. In addition, CLS improved quality of life. Further clinical research is needed to identify predictors that can increase the responder rate and to confirm improvement in clinical outcomes. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Biotronik SE & Co. KG


Arthroplasty ◽  
2021 ◽  
Vol 3 (1) ◽  
Author(s):  
Zhijie Chen ◽  
Kaizhe Chen ◽  
Yufei Yan ◽  
Jianmin Feng ◽  
Yi Wang ◽  
...  

Abstract Objective To evaluate the effect of medial posterior tibial slope (PTS) on mid-term postoperative range of motion (ROM) and functional improvement of the knee after medial unicompartmental knee arthroplasty (UKA). Methods Medical records of 113 patients who had undergone 124 medial UKAs between April 2009 through April 2014 were reviewed retrospectively. The mean follow-up lasted 7.6 years (range, 6.2–11.2 years). Collected were demographic data, including gender, age, height, weight of the patients. Anteroposterior (AP) and lateral knee radiographs of the operated knees were available in all patients. The knee function was evaluated during office follow-up or hospital stay. Meanwhile, postoperative PTS, ROM, maximal knee flexion and Hospital for Special Surgery (HSS) knee score (pre−/postoperative) of the operated side were measured and assessed. According to the size of the PTS, patients were divided into 3 groups: group 1 (<4°), group 2 (4° ~ 7°) and group 3 (>7°). The association between PTS and the knee function was investigated. Results In our cohort, the average PTS was 2.7° ± 0.6° in group 1, 5.6° ± 0.9° in group 2 and 8.7° ± 1.2° in group 3. Pairwise comparisons showed significant differences among them (p < 0.01). The average maximal flexion range of postoperative knees in each group was 112.4° ± 5.6°, 116.4° ± 7.2°, and 117.5° ± 6.1°, respectively, with significant difference found between group 1 and group 2 (p < 0.05), and between group 1 and group 3 (p < 0.05). However, the gender, age, and body mass index (BMI) did not differ between three groups and there was no significant difference between groups in terms of pre−/postoperative HSS scores or postoperative knee ROM. Conclusion A mid-term follow-up showed that an appropriate PTS (4° ~ 7°) can help improve the postoperative flexion of knee. On the other hand, too small a PTS could lead to limited postoperative knee flexion. Therefore, the PTS less than 4° should be avoided during medial UKA.


2021 ◽  
Vol 29 (1) ◽  
pp. 230949902199799
Author(s):  
Tianming Yu ◽  
Jichong Ying ◽  
Jianlei Liu ◽  
Dichao Huang ◽  
Hailin Yan ◽  
...  

Purpose: The study described a novel surgical treatment of Haraguchi type 1 posterior malleolar fracture in tri-malleolar fracture and patient outcomes at intermediate period follow-up. Methods: All patients from January 2015 to December 2017 with tri-malleolar fracture of which posterior malleolar fractures were Haraguchi type 1, were surgically treated in this prospective study. Lateral and medial malleolar fractures were managed by open reduction and internal fixation through dual incision approaches. 36 cases of Haraguchi type 1 posterior malleolar fractures were randomly performed by percutaneous posteroanterior screw fixation with the aid of medial exposure (group 1). And 40 cases were performed by percutaneous anteroposterior screw fixation (group 2). Clinical outcomes, radiographic outcomes and patient-reported outcomes were recorded. Results: Seventy-six patients with mean follow-up of 30 months were included. There were no significant differences in the mean operation time (81.0 ± 11.3 vs. 77.2 ± 12.4), ankle function at different periods of follow-up, range of motions and visual analog scale (VAS) at 24 months between the two groups ( p > 0.05). However, the rate of severe post-traumatic arthritis (Grade 2 and 3) and the rate of step-off rather than gap in radiological evaluation were lower in group 1 than that in group 2 ( p < 0.05). Conclusion: Using our surgical technique, more patients had good outcome with a lower rate of severe post-traumatic arthritis, compared with the group of percutaneous anteroposterior screw fixation. Percutaneous posteroanterior screw fixation can be a convenient and reliable alternative in treating Haraguchi type 1 posterior malleolar fracture.


2021 ◽  
pp. 1-7
Author(s):  
Emre Erdem ◽  
Ahmet Karatas ◽  
Tevfik Ecder

<b><i>Introduction:</i></b> The effect of high serum ferritin levels on long-term mortality in hemodialysis patients is unknown. The relationship between serum ferritin levels and 5-year all-cause mortality in hemodialysis patients was investigated in this study. <b><i>Methods:</i></b> A total of 173 prevalent hemodialysis patients were included in this study. The patients were followed for up to 5 years and divided into 3 groups according to time-averaged serum ferritin levels (group 1: serum ferritin &#x3c;800 ng/mL, group 2: serum ferritin 800–1,500 ng/mL, and group 3: serum ferritin &#x3e;1,500 ng/mL). Along with the serum ferritin levels, other clinical and laboratory variables that may affect mortality were also included in the Cox proportional-hazards regression analysis. <b><i>Results:</i></b> Eighty-one (47%) patients died during the 5-year follow-up period. The median follow-up time was 38 (17.5–60) months. The 5-year survival rates of groups 1, 2, and 3 were 44, 64, and 27%, respectively. In group 3, the survival was lower than in groups 1 and 2 (log-rank test, <i>p</i> = 0.002). In group 1, the mortality was significantly lower than in group 3 (HR [95% CI]: 0.16 [0.05–0.49]; <i>p</i> = 0.001). In group 2, the mortality was also lower than in group 3 (HR [95% CI]: 0.32 [0.12–0.88]; <i>p</i> = 0.026). No significant difference in mortality between groups 1 and 2 was found (HR [95% CI]: 0.49 [0.23–1.04]; <i>p</i> = 0.063). <b><i>Conclusion:</i></b> Time-averaged serum ferritin levels &#x3e;1,500 ng/mL in hemodialysis patients are associated with an increased 5-year all-cause mortality risk.


2021 ◽  
pp. 1-7
Author(s):  
Constantin Roder ◽  
Uwe Klose ◽  
Helene Hurth ◽  
Cornelia Brendle ◽  
Marcos Tatagiba ◽  
...  

<b><i>Background and Purpose:</i></b> Hemodynamic evaluation of moyamoya patients is crucial to decide the treatment strategy. Recently, CO<sub>2</sub>-triggered BOLD MRI has been shown to be a promising tool for the hemodynamic evaluation of moyamoya patients. However, the longitudinal reliability of this technique in follow-up examinations is unknown. This study aims to analyze longitudinal follow-up data of CO<sub>2</sub>-triggered BOLD MRI to prove the reliability of this technique for long-term control examinations in moyamoya patients. <b><i>Methods:</i></b> Longitudinal CO<sub>2</sub> BOLD MRI follow-up examinations of moyamoya patients with and without surgical revascularization have been analyzed for all 6 vascular territories retrospectively. If revascularization was performed, any directly (by the disease or the bypass) or indirectly (due to change of collateral flow after revascularization) affected territory was excluded based on angiography findings (group 1). In patients without surgical revascularization between the MRI examinations, all territories were analyzed (group 2). <b><i>Results:</i></b> Eighteen moyamoya patients with 39 CO<sub>2</sub> BOLD MRI examinations fulfilled the inclusion criteria. The median follow-up between the 2 examinations was 12 months (range 4–29 months). For 106 vascular territories analyzed in group 1, the intraclass correlation coefficient was 0.784, <i>p</i> &#x3c; 0.001, and for group 2 (84 territories), it was 0.899, <i>p</i> &#x3c; 0.001. Within the total follow-up duration of 140 patient months, none of the patients experienced a new stroke. <b><i>Conclusions:</i></b> CO<sub>2</sub> BOLD MRI is a promising tool for mid- and long-term follow-up examinations of cerebral hemodynamics in moyamoya patients. Systematic prospective evaluation is required prior to making it a routine examination.


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