scholarly journals Two-Year Clinical Follow-Up Assessment of the Novel Cingular Surgical Bovine Pericardial Valve

2021 ◽  
Vol 8 ◽  
Author(s):  
Jinmiao Chen ◽  
Minzhi Lv ◽  
Yuntao Lu ◽  
Jiahui Fu ◽  
Yingqiang Guo ◽  
...  

Objectives: To evaluate the 2-year clinical safety and hemodynamic outcomes of the Cingular bovine pericardial bioprosthesis.Methods: A prospective, multicenter, single-arm trial was conducted in patients who required aortic or mitral valve replacement. From March 2016 to October 2017, 197 patients were implanted with the Cingular bovine pericardial valve at five sites in China. The clinical outcomes and hemodynamic performance were assessed through a 2-year follow-up. Clinical safety events were reviewed by an independent clinical events committee, and echocardiographic data were assessed by an independent core laboratory.Results: The mean age was 66.9 ± 4.9 years. The 2-year survival rate was 96.4%. A complete 2-year clinical follow-up was achieved in 189 of 190 survivors. No case of structural valve deterioration, major perivalvular leak, prosthetic valve endocarditis, or valve-related reoperation was seen. For the aortic valve, the mean pressure gradient observed was 12.5 ± 4.0 mm Hg, and the effective orifice area (EOA) was 2.0 ± 0.3 cm2. For the smaller size aortic valves, 19 mm and 21 mm, respective mean EOA values of 1.7 ± 0.2 cm2 and 1.8 ± 0.2 cm2 were found. The values for mean pressure gradient and mean EOA for mitral bioprostheses were 4.0 ± 1.4 mm Hg and 2.2 ± 0.3 cm2, respectively. There was no significant change between 1-year and 2-year hemodynamic performance.Conclusions: The Cingular bovine pericardial valve showed favorable clinical safety and hemodynamic outcomes over a 2-year follow-up. Further follow-up is required to validate the long-term durability.

Author(s):  
José Manuel Martínez-Comendador ◽  
Francisco Estevez-Cid ◽  
Miguel González Barbeito ◽  
Carlos Velasco García De Sierra ◽  
Alberto Bouzas Mosquera ◽  
...  

Abstract OBJECTIVES Durability of sutureless aortic bioprosthetic valves remains a major issue. The aim of this study was to assess structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) of the Perceval bioprosthesis using the new proposed standardized definitions. METHODS All patients who underwent aortic valve replacement with sutureless Perceval S prostheses up to September 2016 were included. Clinical and echocardiographic follow-up was performed. New standardized definitions were used to assess the durability of sutureless bioprosthetic valves. From 2013 to 2016, 214 patients were included. RESULTS The mean age and EuroSCORE II were 79 years and 2.74. Thirty-day mortality was 0.47%. The survival rate was 96.8%, 88.1% and 85.7% at 1, 3 and 4 years, respectively. The median echocardiographic follow-up was 3.28 years. The mean pressure gradient was 11.3 mmHg. No cases showed evidence of severe SVD, 17 patients had moderate SVD with a mean pressure gradient of 24 mmHg and 8 patients had definite late BVF. The incidence of moderate SVD and BVF at 4 years was 8.8% and 2.9%, respectively. CONCLUSIONS Mid-term follow-up to 6.3 years after aortic valve replacement with the Perceval bioprosthesis documents favourable haemodynamic and clinical outcomes and low rates of SVD and BVF.


1995 ◽  
Vol 5 (3) ◽  
pp. 238-242 ◽  
Author(s):  
Narayanswami Sreeram ◽  
Venkateswararao Dikkala ◽  
Robert Arnold

SummaryStenoses of the systemic venous pathways are a potentially dangerous complication after the Mustard operation. The acute and intermediate-term efficacy of balloon dilation of these stenoses has not previously been studied in a large group of patients. A retrospective analysis of clinical and angiographic data, with prospective clinical and echocardiographic follow-up, was performed in a consecutive group of 25 patients (17 male, 8 female) who underwent balloon dilation of the superior or inferior caval venous pathways. For 17 dilations of stenoses in the superior pathway, the mean pressure gradient decreased from 9.1±5.7 to 3.4±2.3 mm Hg (p<0.01), while the diameter of the stenosis increased from 5.9±2.9 to 11.2±3.0 mm (p<0.01). For 25 dilations of the inferior pathway, the mean gradient decreased from 4.3±1.8 to 1.4±1.1 mm Hg (p<0.01), while the diameter of the stenosis increased from 7.3±1.5 to 10.6±2.3 mm (p<0.01). Over a median follow-up of 3.5 years, 16 patients have been without symptoms or signs suggestive of recurrence of stenoses. In the remaining nine patients, 11 further procedures were performed at a median of 3.1 years after initial dilation. In five patients who had previously undergone dilation of the superior (3), inferior (1) or both (1) pathways, further dilations of the same pathway(s) and/or stent implantations were performed. Three patients, including one in whom superior caval venous stenosis had recurred, had developed a new stenosis of a previously undilated pathway, while in two patients no further dilations were required. Balloon dilation offers an alternative to reoperation for stenoses of the systemic venous pathways after the Mustard operation, and appears to provide satisfactory intermediate-term palliation. Recurrences of stenoses in previously dilated pathways, and new stenoses in previously unobstructed pathways, are commonly seen at follow-up. Alternative measures, such as placement of stents, need to be considered in the long-term management of these patients.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Messas ◽  
A Ijsselmuiden ◽  
G Goudot ◽  
S Vlieger ◽  
P Den Heijer ◽  
...  

Abstract Objectives We recently developed a unique transthoracic non-invasive ultrasound therapy device called Valvosoft to treat aortic stenosis. The therapy consists in delivering trans-thoracically precisely focused and controlled short ultrasound pulses (&lt;20μsec) at a high acoustic intensity to produce non-thermal mechanical tissue softening of the calcified aortic valve with the ultimate aim of improving the valve opening. Ultrasound imaging enables to follow valve movements in real-time and thus targets the ultrasound waves on the valve with great precision. After having validated this concept in pre-clinical studies, we aimed at applying this technique in human. The primary objectives were to assess the safety and feasibility of this novel technique along with its performance by evaluation of the valve leaflets mobility and valve opening area. Methods This is a multi-center, prospective, controlled first-in-man study. Ten patients with severe symptomatic calcific aortic stenosis and not eligible for SAVR/TAVR underwent a Valvosoft ultrasound therapy. The therapy consists of 6 sessions of ultrasound therapy. The Valvosoft transducer is applied on the patient's chest and coupled at its center with an echocardiography phased array probe to allow real-time control of the therapy (cavitation bubble detection). Preselection of the region of interest is performed by echo still frame before each session. Ultrasonic evaluation was performed by an independent core lab at baseline, discharge, 30-day and 3 month follow-up along with clinical follow up. Results Enrolled patients were advanced in age (84.1±6.5 yrs) with severe comorbidities (8 with heart failure, 5 with coronary heart disease and 5 with kidney failure). All had extensive aortic valve calcification (mean calcification volume of 687.28 mm3) with mean AVA of 0.61±0.17 cm2 and mean pressure gradient of 37.5±10.5 mmHg (6 patients had SV&lt;35ml/m2). No adverse events were recorded during the procedures other than some benign ventricular extrasystoles. The mean treatment time was 52 minutes. At 3 months follow-up, one patient had died due to end stage heart failure not linked to the procedure (9 weeks post procedure) and another got finally TAVI (45 days post procedure). Of the other 8 patients, 6 experienced an improvement of their NYHA status. No device or procedure related major adverse events nor deterioration of neurological status were observed at 3 months follow-up. Of the 7 patients that had echo follow-up at 3 months (one patient refused to get echo evaluation), 5 increased the AVA (between 14% and 46%) and 4 patients decreased the mean pressure gradient (from 6% to 44%). No AI or EF deterioration occurred during follow up. Conclusion Non-invasive ultrasound therapy is feasible and safe in patients with severe aortic valve stenosis and is able to improve AVA and pressure gradient in some patient. Larger studies with longer follow up will need to be conducted. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Cardiawave SA, Paris, France


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
P Werner ◽  
M Russo ◽  
M Seewald ◽  
I Coti ◽  
T Haberl ◽  
...  

Abstract Background Structural valve deterioration (SVD) with associated bioprosthetic valve dysfunction remains an unsolved problem, exposing patients to the risk of aortic valve re-intervention after surgical aortic valve replacement (SAVR). Several strategies have been proposed to improve prosthesis design for optimal performance. The leaflets of the Trifecta valve are mounted on the outside of the prosthetic stent to achieve a larger orifice area. Although favourable early clinical outcomes have been reported, long-term durability still needs to be assessed. Purpose The aim of the current study was to assess the mid-term overall mortality and re-intervention rate in patients who received a Trifecta valve with a follow-up >5 years. Methods Patients who underwent SAVR at our centre between 2011 and 2012 were identified in the internal, prospective database. All patients with implantation of a Trifecta valve in aortic position were included. Primary endpoints were freedom from overall mortality and from re-operation at latest follow-up (FU). Additionally, assessment of echocardiographic parameters at baseline and follow-up was performed. Results Seventy-six patients (age 77.3±9.5 years, BMI 28.6±5.8, 68% male) were included in the study. EuroScore II was 7.2% (± 7.7) while mean STS-Mortality score was 2.4±1.1%. Of all procedures, 53% were isolated aortic valve replacements, whereas concomitant procedures were performed in 47% of cases (37% CABG, 12% mitral surgery, 8% tricuspid surgery). Baseline echocardiographic assessment showed a mean pressure gradient (MPG) of 51±21 mmHG, a peak pressure gradient (PPG) of 78±36 mmHG and a peak velocity (Vmax) of 4.2±1.1 m/s. Thirty-day mortality was 7%. Freedom from overall mortality at 1 year and 5 years was 84% and 73%, respectively. Freedom from death and freedom from re-operation at latest FU (6.7±0.5 years) was 68% and 90%, respectively. In a composite endpoint analysis, freedom from death or re-intervention at latest follow up was 60%. A total of 7 patients underwent aortic valve re-interventions (re-replacements n=5, valve-in-valve n=2). Indications for re-interventions were SVD (n=5), NSVD (n=1, pannus ingrowth) and endocarditis (n=1). One case of re-stenosis occurred in a patient who was deemed not feasible for aortic valve re-intervention and died. Kaplan Meier analysis Conclusion(s) To our knowledge, this patient cohort presents with the lowest rate of freedom from re-operation (90%, 6.7±0.5 years) after SAVR with the Trifecta valve. A relatively high number of SVD and NSVD has been observed, which might be attributable to the specific leaflet mounting or the deformable valve frame of the first generation. Current results call for further investigation with prospective echocardiographic follow-up in this patient group. Acknowledgement/Funding None


2020 ◽  
Vol 20 (01) ◽  
pp. 1950074
Author(s):  
AMINA HALAIMI ◽  
BOUALEM CHETTI ◽  
BOUALEM LARIBI ◽  
OMAR LABBADLIA

This work presents a developed zero-dimensional cardiovascular (CV) system model, based on an electrical analogy, with a detailed compartmental description of the heart and the main vascular circulation which is able to simulate normal and diseased conditions of CV system, especially the stenosis valvular aortic. To know the effect of each parameter on hemodynamics, the number of parameters is increased by adding more segments. The developed model consists of 14 compartments. The results show that the severity of aortic stenosis (AS) effect varies with the effective orifice area and the mean pressure gradient for the case of no AS; the effective orifice area is 4[Formula: see text]cm2 and the mean pressure gradient is 0[Formula: see text]mmHg, while for the case of mild AS, the effective orifice area is 1.5[Formula: see text]cm2 and the mean pressure gradient is 27.24[Formula: see text]mmHg. For the case of moderate AS, the effective orifice area is 1.0[Formula: see text]cm2 and the mean pressure gradient is 44.68[Formula: see text]mmHg. For the case of the severe AS, the effective orifice area is 0.61[Formula: see text]cm2 and the mean pressure gradient is 77.51[Formula: see text]mmHg. It is found that the developed model can estimate an accurate value of the effective orifice area for any value of mean pressure gradient in AS. The results obtained for the CV system under normal and diseased conditions show a good agreement compared to published results.


2018 ◽  
Vol 67 (04) ◽  
pp. 266-273
Author(s):  
Arnaud Van Linden ◽  
Mani Arsalan ◽  
Thore Körschgen ◽  
Johannes Blumenstein ◽  
Jörg Kempfert ◽  
...  

Background Modern supraannular aortic xenografts offer a special design, thus providing maximized opening area for improved hemodynamics. The aim of this study was a prospectively randomized comparison of the Trifecta and the Perimount Magna Ease valves based on metric annulus sizing. Methods A total of 100 patients with aortic stenosis undergoing aortic valve replacement (AVR) with or without concomitant procedures were prospectively included. After decalcification of the annulus, stratified intraoperative randomization was performed. The diameter of the aortic annulus was measured using metric Hegar dilators and randomization was based on this metric annulus diameter. Exercise echocardiography was performed at 10-month follow-up. Results Mean age was 69 years, with 36% female. Predominant implanted valve sizes were 23 mm (39%) and 25 mm (32%). Unadjusted mean pressure gradient was significantly lower and effective orifice area larger for the Trifecta group (10.8 ± 5 vs. 13.2 ± 4 mm Hg, p = 0.02 and 1.93 ± 0.39 vs. 1.70 ± 0.30 cm2, p = 0.002) at discharge. In patients with small annuli, based on the metric annulus size there were no significant differences in gradients or the orifice area. At exercise echocardiography follow-up, there were no significant hemodynamic differences between both prostheses. Conclusions The Trifecta and the Perimount Magna Ease prostheses both show excellent hemodynamic performance after AVR. In patients with larger annuli, the Trifecta valve seems to be even superior to the Magna Ease, which may be advantageous in obese patients.


Author(s):  
Naoki Tadokoro ◽  
Satsuki Fukushima ◽  
Yusuke Shimahara ◽  
Tetsuya Saito ◽  
Naonori Kawamoto ◽  
...  

Abstract Objectives A new stented bovine pericardial valve (Avalus™) has been proven safe and effective with good hemodynamic performance in Western populations. However, its use in Japanese patients is poorly understood. We retrospectively compared the feasibility, safety, and valve haemodynamics between the Avalus™ and Magna™ valves in patients who underwent surgical aortic valve replacement (SAVR). Methods This study included 87 patients receiving an Avalus™ valve and 387 receiving a Magna™ valve. We evaluated adverse events, outcomes, and valve haemodynamics within 1 year postoperatively. There were no significant differences in any surgical risk scores. Results No in-hospital mortality occurred in the Avalus™ group, but two mortality events occurred in the Magna™ group. No pacemaker implantation for complete atrioventricular block was required in the Avalus™ group. There was no significant difference in in-hospital or clinical outcomes between the two groups until 1 year postoperatively. Left ventricular mass index reduction appeared to predominate in the Avalus™ over Magna™ group. There was no significant difference in the mean pressure gradient or effective orifice area of each valve size at 1 week or 1 year between the two groups, apart from the mean pressure gradient of the 23-mm valve at 1 week. Three patients (3.4%) in the Avalus™ group and 39 (10.8%) in the Magna™ group (p = 0.12) had severe patient–prosthesis mismatch at 1 week postoperatively. Conclusions The new Avalus™ stented aortic valve bioprosthesis was associated with good in-hospital outcomes and good valve functionality post-SAVR in Japanese patients.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Piayda ◽  
A Wimmer ◽  
H Sievert ◽  
K Hellhammer ◽  
S Afzal ◽  
...  

Abstract Background In the era of transcatheter aortic valve replacement (TAVR), there is renewed interest in percutaneous balloon aortic valvuloplasty (BAV), which may qualify as the primary treatment option of choice in special clinical situations. Success of BAV is commonly defined as a significant mean pressure gradient reduction after the procedure. Purpose To evaluate the correlation of the mean pressure gradient reduction and increase in the aortic valve area (AVA) in different flow and gradient patterns of severe aortic stenosis (AS). Methods Consecutive patients from 01/2010 to 03/2018 undergoing BAV were divided into normal-flow high-gradient (NFHG), low-flow low-gradient (LFLG) and paradoxical low-flow low-gradient (pLFLG) AS. Baseline characteristics, hemodynamic and clinical information were collected and compared. Additionally, the clinical pathway of patients (BAV as a stand-alone procedure or BAV as a bridge to aortic valve replacement) was followed-up. Results One-hundred-fifty-six patients were grouped into NFHG (n=68, 43.5%), LFLG (n=68, 43.5%) and pLFLG (n=20, 12.8%) AS. Underlying reasons for BAV and not TAVR/SAVR as the primary treatment option are displayed in Figure 1. Spearman correlation revealed that the mean pressure gradient reduction had a moderate correlation with the increase in the AVA in patients with NFHG AS (r: 0.529, p&lt;0.001) but showed no association in patients with LFLG (r: 0.145, p=0.239) and pLFLG (r: 0.030, p=0.889) AS. Underlying reasons for patients to undergo BAV and not TAVR/SAVR varied between groups, however cardiogenic shock or refractory heart failure (overall 46.8%) were the most common ones. After the procedure, independent of the hemodynamic AS entity, patients showed a functional improvement, represented by substantially lower NYHA class levels (p&lt;0.001), lower NT-pro BNP levels (p=0.003) and a numerical but non-significant improvement in other echocardiographic parameters like the left ventricular ejection fraction (p=0.163) and tricuspid annular plane systolic excursion (TAPSE, p=0.066). An unplanned cardiac re-admission due to heart failure was necessary in 23.7% patients. Less than half of the patients (44.2%) received BAV as a bridge to TAVR/SAVR (median time to bridge 64 days). Survival was significantly increased in patients having BAV as a staged procedure (log-rank p&lt;0.001). Conclusion In daily clinical practice, the mean pressure gradient reduction might be an adequate surrogate of BAV success in patients with NFHG AS but is not suitable for patients with other hemodynamic entities of AS. In those patients, TTE should be directly performed in the catheter laboratory to correctly assess the increase of the AVA. BAV as a staged procedure in selected clinical scenarios increases survival and is a considerable option in all flow states of severe AS. (NCT04053192) Figure 1 Funding Acknowledgement Type of funding source: None


2009 ◽  
Vol 7 (3-4) ◽  
pp. 0-0
Author(s):  
Sigitas Čibiras ◽  
Eugenijus Kosinskas

Sigitas Čibiras, Eugenijus KosinskasVilniaus universiteto Širdies ir kraujagyslių ligų klinika, Vilniaus universiteto ligoninės Santariškių klinikos, Santariškių g. 2, LT-08661 VilniusE-mail: [email protected] Įvadas Darbo tikslas – apibendrinti 20 metų patirtį ir įvertinti įgimtos plaučių arterijos (PA) stenozės balioninės valvuloplastikos (BPV) tiesioginius, tarpinius ir vėlyvuosius rezultatus. Ligoniai ir metodai 1987–2007 metais Vilniaus širdies ligų klinikoje buvo atlikta 101 BPV, ligonių amžius nuo 1 paros iki – 39 metų. BPV atlikta esant spaudimo per PA vožtuvą skirtumui > 30 mm Hg. Ligoniai prieš BPV suskirstyti į dvi grupes pagal tai, ar pradinis spaudimo per PA vožtuvą skirtumas <50 mm Hg (1 gruoė), ar > 50 mm Hg (2 grupė). Analizuotas duomenų kitimas tiesiogiai po BPV, tarpiniu laikotarpiu (iki dvejų metų po BVP), vėlyvuoju laikotarpiu (praėjus daugiau kaip dvejiems metams). Ligoniai po BPV buvo suskirstyti į dvi grupes: turintys liekamąjį spaudimo skirtumą iki 36 mm Hg ir daugiau kaip 36 mm Hg. Rezultatai BPV atlikta 18 pacientų, kurių spaudimo per PA vožtuvą skirtumas < 50 mm Hg. Iškart po BVP spaudimo skirtumas per PA vožtuvą sumažėjo nuo 39,5 ± 5 iki 15,83 ± 8,37 mm Hg, tarpiniu laikotarpiu – iki 20 ± 6 mm Hg, vėlyvuoju – iki 21,5 ± 5 mm Hg. BPV atliktos 83 pacientams, kurių spaudimo per PA vožtuvą skirtumas > 50 mm Hg. Tiesiogiai po BVP vidutinis spaudimo skirtumas sumažėjo nuo 81,31 ± 21,28 iki 31,32 ± 13,82 mm Hg, tarpiniu laikotarpiu – iki 27,56 ± 12,71 mm Hg, vėlyvuoju – iki 19,89 ± 10,12 mm Hg. Esant liekamajam spaudimo skirtumui po BPV < 36 mm Hg (58 ligoniai), tarpiniu lakotarpiu vidutinis spaudimo skirtumas 23,66 ± 9,29 mm Hg, vėlyvuoju – 16,85 ± 7,98 mm Hg. Esant liekamajam spaudimo skirtumui po BPV > 36 mm Hg (21 ligonis), tarpiniu laikotarpiu vidutinis spaudimo skirtumas 51,99 ± 20,61 mm Hg, vėlyvuoju – 35,7 ± 16 mm Hg. Vėlyvuoju laikotarpiu spaudimo skirtumas mažėja, bet didėja PA nesandarumas. Tuoj po BPV nesandarumas nustatytas 7 %, tarpiniu laikotarpiu – 53 %, vėlyvuoju – 81,7 % ligonių. Išvados BPV yra gerai toleruojamas ir veiksmingas nechirurginis gydymo būdas. Daugumai ligonių išryškėja vėlyvasis nedidelis plaučių arterijos nesandarumas, kurį retai prireikia gydyti chirurginiu būdu. Mūsų studija rodo, kad tinkama ligonių atranka leidžia pasiekti gerų tiesioginių, tarpinius ir vėlyvųjų rezultatų. Reikšminiai žodžiai: įgimtos širdies ydos, įgimta plaučių arterijos vožtuvo stenozė, balioninė valvuloplastika. Balloon pulmonary artery valvuloplasty – immediate, mid-term and long-term follow-up results: 20-year experience Sigitas Čibiras, Eugenijus KosinskasVilnius University Clinic of Heart and Vascular Medicine, Vilnius University Hospital Santariškių Klinikos, Santariškių str. 2, LT-08661 Vilnius, LithuaniaE-mail: [email protected] Background To analyze immediate, mid-term and long-term follow-up results after percutaneous balloon pulmonary valvuloplasty (BPV) of congenital pulmonary artery (PA) stenosis for a 20-year period. Patients and methods During 1987–2007, in the Vilnius Clinic of Heart Diseases 101 BPV were performed, the patients’ age range being 1 day – 39 years. BPV was performed with the primary PA valvular pressure gradient > 30 mm Hg. Patients before BPV had been divided into two groups: (1) with primary PA pressure gradient < 50 mm Hg; (2) with primary PA pressure gradient > 50 mm Hg. Data were analyzed immediately after BPV, in a mid-term (2 years) and a long-term (more than 2 years) follow-up. The same patients after BPV were divided into two groups: with residual pressure gradient < 36 mmHg and > 36 mmHg. Results Eighteen BPV were performed with the primary PA pressure gradient < 50 mm Hg: the immediate mean pressure gradient decreased from 39.5  ±   5 to 15.83 ± 8.37 mm Hg, in the mid-term period to 20 ± 6 mm Hg, and in the long-term to 21.5 ± 5 mm Hg. Eighty-three BPV were performed with the primary PA pressure gradient > 50 mm Hg; the immediate mean pressure gradient decreased from 81.31 ± 21.28 mm Hg to 31.32 ± 13.82 mm Hg, in the mid-term period to 20 ± 6 mm Hg and in the long-term period to mm Hg. With the residual pressure gradient after BPV < 36 mm Hg (58 patients), in the mid-term period the pressure gradient decreased to 23.66 ± 9.29 mm Hg and in the long-term period to 16.85 ± 7.98 mm Hg. With the residual pressure gradient after BPV > 36 mm Hg (21 patients), in the mid-term period the pressure gradient decreased to 51.99 ± 20.61 mm Hg and in the long-term period to 35.7 ± 16 mm Hg. In the long-term follow-up, the pressure gradient decreased, but PA regurgitation (PAR) was progressive. Immediately after BPV, PAR was seen in 7%, in mid-term follow-up in 53 %, and in long-term follow-up in 81.7 % patients. Conclusions BPV is a well tolerated and effective non-surgical treatment method. Late trivial PAR develops in the majority of cases, but rarely requires surgical treatment. Our study has demonstrated that the appropriate patient selection enables achieving good immediate, mid-term and long-term follow-up results. Keywords: congenital heart defects, congenital pulmonary artery stenosis, balloon valvuloplasty.


2021 ◽  
Author(s):  
Sonia B. Albanese Albanese

Background: Surgical treatment of isolated pulmonary valve stenosis in infants and children has evolved over the years, shifting from the original exclusive aim at lowering right ventricle pressure to the current concomitant focus on preserving pulmonary valve function. In our study, we sought to analyze the effect of such evolving philosophy on long-term results. Methods: All consecutive patients treated in our center between July 1983 and March 2019 were included. Patients were categorized into 2 groups based on the introduction into treatment practice of sparing valve techniques (1995). Actuarial survival, freedom from reintervention on the right outflow tract, transvalvular mean pressure gradient decrease, and pulmonary valve function at follow-up were analyzed. Results: One hundred twenty-three patients operated before (Group I, n=81) or since (Group II, n=42) 1995 were enrolled in the study. Mean age and weight were 3.0 ± 0.36 years and 16.6 ± 1.7kg, respectively. Early mortality occurred exclusively in 3 patients of Group 1. Transvalvular mean pressure gradient decreased in the entire patient population (from 63.28 ± 12.9mmHg to 16.46 ± 7.9mmHg). At a mean follow-up interval of 4.9 ± 33 years, freedom from death was comparable, but freedom from right ventricular outflow tract reintervention was significantly greater in Group II. Although the transvalvular gradient remained stable over time in non-reoperated survivors (mean value of 16.46 ± 7.9mmHg), pulmonary valve function on 2D-Echo showed severe incompetence in 2 patients of Group I and just mild to moderate incompetence in 20 patients of Group II, with a significantly negative effect of unsuccessful preoperative pulmonary balloon valvuloplasty (14/20 vs 6/20, p=0.025) in the latter. Conclusion: Current pulmonary valve sparing techniques are associated with better results, particularly in terms of freedom from re-interventions and pulmonary valve function at follow-up. Balloon valvuloplasty prior to surgery may worsen operative results, promoting pulmonary insufficiency and therefore should probably be avoided in all patients in whom anatomical characteristics predict failure of percutaneous therapy.


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