Balloon valvuloplasty of pulmonary stenosis in infants and children -- Co-operative study of the German Society of Pediatric Cardiology

Balloon valvuloplasty (BVP) of pulmonary stenosis (PST) wasperformed in 305 infants and children in 20 heart centres ofthe Federal Republic of Germany. 273 patients suffered fromisolated PST. Their age ranged from 3 days to 18 years (mean= 5.85 ±4.82 years), their weight from 2.9 to 60 kg.The pressure gradient was measured invasively in the sedatedor anaesthetized child, partly by CW Doppler. BVP was performedby mono- or trefoil catheters, mostly oversized. As a result,mean pressure gradient fell from 71.7±32mmHg before to31.8±25 mmHg immediately after BVP(P< 0.0001). Thegradient was reduced by <30% in 13% of the patients, by 30–49%in 23%, and by 50% in 64%. Among 33 patients with a gradientreduction of <30%, nine were aged <1 year, nine had dysplasticvalves, and nine had a short-term infundibular reaction andgood late results. Gradient reduction was not improved withoversized balloons and was independent of the initial gradient.Follow-up for a mean 11.2±8 months showed a further slightimprovement, probably due to regression of infundibular hypertrophy.In the whole group we observed infundibular reaction in 12%,serious complications with one late death in 4%. From the start,BVP proved to be a secure and effective tool for eliminationof pulmonary stenosis.     

Percutaneous balloon pulmonary valvuloplasty: A modified over-the-wire Inoue balloon technique for difficult right ventricular anatomy

Percutaneous balloon pulmonary valvuloplasty (BPV) is the mainstay of treatment for significant pulmonary stenosis with doming leaflets. Various techniques have been described in the literature including the use of Inoue Percutaneous Transseptal Mitral Commissurotomy (PTMC) catheter with standard 0.025″ guidewire. But if right ventricular anatomy is not suitable, 0.025″ guidewire doesn''t provide enough support to track the Inoue PTMC catheter. Here, we report a case of successful BPV using a novel technique of slenderizing the Inoue Percutaneous Transseptal Mitral Commissurotomy (PTMC) catheter over an Amplatz superstiff 0.035″ guidewire. This technique may be useful during BPV in difficult right ventricular inflow and outflow tract anatomy in patients with congenital pulmonary valve stenosis.     

采用不同球囊行肺动脉瓣成形术

对２５例肺动脉瓣狭窄患者行经皮球囊扩张术，探讨（Ｍａｎｓｆｉｅｌｄ球囊和Ｉｎｏｕｅ球囊对手术效果的影响及其优缺点。结果表明：Ｉｎｏｕｅ球囊导管进行经皮肺动脉瓣扩张术可取得与Ｍａｎｓｆｉｅｌｄ球囊导管法相似的疗效，但比Ｍａｎｓｆｉｅｌｄ球囊导管法具有更多的优点，如操作简便、可顺序扩张，并发症少等。     

经皮球囊肺动脉瓣成形术治疗婴儿重度肺动脉瓣狭窄及室间隔完整的肺动脉瓣闭锁

目的:总结经皮球囊肺动脉瓣成形术(percutaneous balloon pulmonary valvuloplasty,PBPV)治疗婴儿重度肺动脉瓣狭窄(pulmonary stenosis,PS)及室间隔完整的肺动脉瓣闭锁(pulmonary atresiawith intact ventricular septum,PA/IVS)的经验,评价其疗效及安全性。方法:自2007年1月至2012年10月,采用PBPV治疗婴儿重度PS及PA/IVS患者共33例,男性24例,女性9例,手术年龄3～12(8.9±2.9)个月,体质量5～11.5(9.0±1.6)kg。术前完善心电图、X线片、超声心动图、右心导管检查及右心室造影,采用单球囊扩张完成PBPV。PA/IVS患儿需先行肺动脉瓣射频打孔术。结果:球囊扩张手术技术成功率为96.97%(32/33)。右心室收缩压(right ventricular systolic piessure,RVSP)由术前的95～205(130.8±28.2)mmHg(1 mmHg=0.133kPa)下降至28～135(73.2±27.4)mmHg(t=12.067,P<0.001);肺动脉瓣跨瓣压差由术前的81～180(110.3±26.3)mmHg下降至10～112(47.7±23.8)mmHg(t=12.958,P<0.001)。1例术中出现心脏压塞,转外科急诊手术,术后恢复良好。出院时10例患者复查超声心动图仍显示平均跨肺动脉瓣压差>50 mmHg;随访中值时间26个月,3例残余重度肺动脉瓣狭窄,2例接受二次PBPV后压差降至轻度。本组术后发生轻度以上肺动脉瓣关闭不全(pulmonary insufficiency,PI)22例。结论:随着介入技术的不断提高,经皮肺动脉瓣球囊扩张术,已成为救治婴儿危重先天性肺动脉瓣狭窄及肺动脉瓣闭锁的安全有效的重要方法。     

球囊肺动脉瓣成形术疗效的影响因素和术后心脏形态学的变化

目的　判明影响经皮球囊肺动脉瓣成形术 (PBPV)疗效的因素和术后心脏形态学的变化。方法　用逐步回归法对 138例患者术前和术后的跨瓣压差、球囊 瓣环比值、肺瓣口面积和球囊充盈时间进行分析 ;对术前和术后的右室腔直径、右室壁厚度和ECG的Rv1 行t检验 ;对术前、术后和随访所测量的跨瓣压差行单因素方差分析。结果　术前跨瓣压差 (13 5 5± 0 6 9)kPa ,术后压差 (4 5 1± 0 4 1)kPa ,下降百分比为 6 1 4 1%± 2 6 2 % (P <0 0 0 1) ;设术后残余压差 (A)为因变量 ,术前跨瓣压差 (X)、球囊 /瓣环比值 (Y)、肺瓣口面积 (Z)和球囊充盈时间 (W)为自变量 ,得回归方程为A =13 94 +0 3114X - 6 2 4 5 5Y - 0 775 1Z ,R2 =0 6 74 8;10 7例患者得到随访 ,随访时间为 89± 2 8(38～ 12 6 )个月 ,平均随访压差 (3 38± 0 4 7)kPa ,随访压差较前明显降低 (P <0 0 0 1) ;随访所测量的右室腔直径、右室壁厚度和ECG的Rv1 较治疗前有显著良性转归 (P均 <0 0 5 )。结论　先天性肺动脉瓣狭窄 (PVS)严重程度是影响PBPV疗效的关键因素 ,术后心脏形态学可以发生一定程度的好转 ,但大年龄患者的好转机会小于儿童。提示PVS一经确诊 ,即应行PBPV治疗。     

Predictors of successful pulmonary balloon valvuloplasty: 10-year experience

At our institution, 55 infants and children (ages 0.3–21 yr, median 2.5 yr) underwent pulmonary balloon valvuloplasty between August 1983 and May 1993. Systolic pressure gradients fell acutely following balloon valvuloplasty from 63.5 ± 24.8 mmHg (mean ± standard deviation) to 26.7 ± 12.9 mmHg (P < 0.001) with a decrease in systolic pressure ratio from 0.81 ± 0.25 to 0.42 ± 0.12 (P < 0.0001). Fifty of the 55 patients had long-term echocardiographic evaluation performed >2 yr following balloon valvuloplasty. Thirty-four of the 50 patients (Group A; 68%) were classified as having successful (residual systolic gradients <25 mmHg, ventricular systolic pressure ratios <0.6) long-term outcomes. Their peak systolic gradients fell acutely from 58.8 ± 16.6 mmHg to 22.7 ± 11.2 mmHg (P < 0.001). At 4.6 ± 2.3 yr postvalvuloplasty, peak instantaneous pressure gradients were 17.8 ± 5.7 mmHg (P = ns vs. acute postvalvuloplasty). Fifteen of the 50 patients (Group B; 30%) had unsuccessful (residual systolic gradients ≥25 mmHg and/or ventricular systolic pressure ratios >0.6) long-term outcomes. Their peak instantaneous systolic gradients fell acutely from 76.5 ± 33.1 mmHg to 36.6 ± 11.4 mmHg (P < 0.05). At 3.8 ± 1.7 yr postvalvuloplasty, peak instantaneous pressure gradients were 35.1 ± 9.1 mmHg (P = ns vs. acute postvalvuloplasty). One 3-yr-old patient (Group C, 2%) required repeat balloon valvuloplasty on two separate occasions for recurrent stenosis. There was no significant prevalvuloplasty difference between Groups A and B with regard to age, weight, or Z scores of the pulmonary annull or balloon/annulus ratio; however, patients in Group A had significantly lower prevalvuloplasty gradients and lower systolic pressure ratios than patients in Group B. Total systolic gradient reduction between patients with successful and unsuccessful outcomes was not significantly different (Group A: 36.1 ± 16.6 mmHg; Group B: 41 ± 22.3 mmHg). At long-term follow-up, patients in Group A had fewer symptoms and a significantly lower rate of electrocardiographic right ventricular hypertrophy than Group B patients. Successful outcomes defined by our criteria following balloon valvuloplasty were achieved in 68% of patients with greatest long-term success in patients with prevalvuloplasty systolic gradients <60 mmHg and systolic pressure ratios <0.8. Intervention at lesser systolic gradients (40–60 mmHg) appears indicated to achieve lower long-term gradients and fewer symptoms as total systolic gradient reduction by this technique is limited. © 1996 Wiley-Liss, Inc.     

Determinants of immediate and follow-up results of pulmonary balloon valvuloplasty

The data of 93 patients (age 11.4 ± 9.4 years, range 8 months - 56 years) who underwent pulmonary balloon valvuloplasty (PBV) for valvular pulmonic stenosis (PS) in our institution are reviewed. The patients were classified into three groups: Group I (34 patients) had a right ventricular (RV) to aortic systolic pressure ratio of < 1, Group II (39 patients) had suprasystemic RV systolic pressures, and Group III (20 patients) included patients with elevated mean right atrial (RA) pressures irrespective of the RV systolic pressures. The percentage drop in immediate postdilatation peak systolic gradients (PSG) and the follow-up PSG were similar in the three groups and were not influenced by any predilatation patient characteristics. A balloon-annulus ratio < 1 predicted a poorer follow-up outcome. Nine patients, eight of Group III and one of Group II, experienced difficult procedures requiring sequential use of progressively larger balloon catheters. Eleven patients, six of Group II and five of Group III, experienced procedure-related events (hypotension, bradycardia/asystole, hypoxia, apnea, tachyarrhythmias, and seizures) and one patient (Group II) died. Although changes in immediate and follow-up gradients after PBV are not influenced by the severity of PS, difficult procedures and procedure-related events are particularly common in patients with severe PS and elevated RA pressures. A cautious and planned approach is therefore indicated in these patients.     

Long‐term outcomes up to 25 years following balloon pulmonary valvuloplasty: A multicenter study

Objective: Evaluate long‐term outcomes following balloon pulmonary valvuloplasty (BPV) for pulmonary stenosis (PS).
Background: Long‐term data following BPV is limited to small, single center studies.
Methods: BPV from April 12, 1985 to January 7, 2015 from three centers were included. Outcomes studied were ≥ moderate PI by echocardiogram and residual PS ≥ 40 mm Hg. Risk factors for ≥ moderate PI, residual PS, and repeat intervention were assessed by univariate and multivariate analysis.
Results: Among 254 patients, mean age at BPV was 3.8 years (range 1 day‐67 years), initial PS catheter gradient was 56 mm Hg (IQR 40‐70), 19% had critical PS, and 9% had genetic syndromes. Mean follow‐up duration was 7.5 years (maxi‐ mum 25 years). Sixty‐nine (29%) had ≥ moderate PI, 41 patients (17%) had residual PS > 40 mm Hg, and 31 (13%) had re‐intervention. In univariate analysis, younger age, lower weight, greater initial PS gradient, greater initial RV/systemic pressure ratio, critical PS, and longer follow‐up duration were associated with ≥ moderate PI. Greater initial PS gradient was associated with long‐term residual PS or repeat intervention. In multivariate analysis, greater initial gradient and lower weight were independently associated with > moderate PI and greater initial PS gradient and genetic abnormality were independently associated with residual PS and repeat intervention.
Conclusion: Smaller patients with greater initial PS were more likely to develop sig‐ nificant long‐term PI. Patients with greater initial PS and genetic abnormalities were more likely to have residual PS or require repeat intervention following BPV.     

老年人经皮球囊二尖瓣成形术

目的:探讨经皮球囊二尖瓣成形术(PBMV)治疗老年人二尖瓣狭窄(MS)的临床疗效。方法:采用Inoue法对13例年龄≥60岁的MS患者施行PBMV,其中10人接受5-12年中长期随访,收集术前、术后及随访结束时有关心脏参数,进行分析比较。结果:术前、术后及随访5-12年测得参数:(1)二尖瓣瓣口面积(MVA)分别为:0.96±0.15 cm2、1.73±0.27 cm2、1.51±0.32 cm2(P<0.01),后两者与术前比较P<0.01;(2)二尖瓣跨瓣压分别为2.82±1.51 kPa、0.87±0.34 kPa、1.52±0.41 kPa,后两者与术前比较P<0.01;(3)左房平均压分别为3.82±1.73kPa、1.81±0.95 kPa、2.16±0.52 kPa,后两者与术前比较P<0.01。术后心功能改善1级以上者100％,术后5-12年随访心功能仍维持在Ⅱ级以上者占80％,5-12年后再狭窄发生率20％。结论:PBMV治疗老年人MS的近期及中远期疗效均满意,未见严重并发症,是一种安全有效的治疗方法。     

Success determining factors in percutaneous transluminal balloon valvuloplasty of pulmonary valve stenosis

Twenty-two percutaneous transluminal balloon valvuloplasty procedures were performed on 21 patients with congenital pulmonary valve stenosis. The peak systolic pressure gradient was immediately reduced from 79.1 +/- 7.4 to 22.2 +/- 1.8 mmHg, (P less than 0.0001) and follow-up cardiac catheterization at 5.3 +/- 0.4 months in 19 patients revealed no further significant change in gradient (23.5 +/- 3.2 mmHg). The best results were obtained when balloons larger than the pulmonary annulus were used, i.e. an immediate residual transvalvular gradient of 22.0 +/- 2.2 mmHg with a balloon/annulus ratio greater than 1, as opposed to 44.2 +/- 5.4 with a balloon/annulus ratio = 1 (P less than 0.001). The angiographically determined cusp thickness of the stenotic pulmonary valves was significantly greater than that of the control group of 24 patients without pulmonary valve stenosis (1.21 +/- 0.09 vs 0.59 +/- 0.02 mmHg, P less than 0.00001). The relationship between this parameter and the residual transvalvular gradient at follow-up was found to be significant (r = 0.77, P less than 0.001). It is concluded that balloon size is a determinant factor in achieving good results with percutaneous balloon valvuloplasty although cusp thickness, a factor to which scant regard has hitherto been paid, also plays a significant role in the residual transvalvular gradient measured at follow-up.     

经皮球囊二尖瓣成形术治疗二尖瓣狭窄合并房颤的疗效

目的　对二尖瓣狭窄 (MS)合并房颤 (Af)患者经皮球囊二尖瓣成形成术 (PBMV)后 3～ 11年的随防资料作回顾性分析 ,以探讨该方法在MS合并房颤 (Af)患者中的中远期疗效及其影响因素。方法　对 1992年 10月～ 2 0 0 0年 12月在我院行PBMV治疗的 60 0例MS患者的资料作回顾性研究 ,合并Af者 2 75例 (Ⅰ组 ) ,其余 3 2 5例为窦性心律者 (Ⅱ组 ) ,随防时间 3年～ 11年 ,平均 ( 5 .3± 3 .9)年。结果　Ⅰ组与Ⅱ组比较 ,中远期再狭窄率分别为 3 2 .3 %和 10 % ,需要药物治疗的心功能不全分别为 2 7%和 3 .6% ,死亡率分别为 1.8%和 0 .9% ,改行开胸换瓣或再次PBMV分别为 8.8%和 1.3 5 % ,脑栓塞分别为 2 .6%和 0 .45 %。结论　PBMV对MS合并Af患者的治疗中远期疗较窦性心律者差 ;总的并发症不高 ,疗效较好 ,预防并发症的发生及取得远期良好疗效的关键是病例选择     

经皮球囊二尖瓣成形术治疗二尖瓣狭窄合并房颤的近期与远期疗效

目的　探讨经皮球囊二尖瓣成形术 (PBMV)在二尖瓣狭窄 (MS)合并心房颤动 (Af)患者中的疗效与安全性。方法　观察 12 5例MS合并Af患者 (Ⅰ组 )与 2 2 5例MS伴窦性心律患者 (Ⅱ组 )的PBMV成功率、PBMV后血流动力学与超声心动图指标改变、远期随访结果及并发症情况。结果　(1)两组成功率分别为 96 %(12 0 12 5 )和 99 6 %(2 2 4 2 2 5 ) (P <0 0 5 )。 (2 )PBMV后即刻两组左心房压力与肺动脉压力均明显下降 (P均 <0 0 0 1) ,Ⅰ组前者降值 <Ⅱ组 (P <0 0 5 )。 (3)PBMV后近期两组二尖瓣口面积 (MVA)明显增大 (P均 <0 0 0 1) ,组间无差异 ;两组左心房内径 (LAD)明显下降 (P均 <0 0 0 1) ,Ⅰ组下降值 <Ⅱ组。 (4)远期随访两组再狭窄率分别为 17 0 %(8 4 7)和 6 9%(4 5 8) (P <0 0 5 ) ;两组死亡率分别为 4 1%(2 4 9)和 1 7%(1 5 9) (P <0 0 5 ) ;两组MVA与LAD均仍较术前明显改善 ,但Ⅰ组较Ⅱ组差 ,且Ⅰ组MVA较术后近期结果缩小 (P <0 0 5 )。 (5 )两组并发症发生率分别为16 8%及 10 7%,组间差异无显著性 ,但 5例体循环栓塞者均发生于Ⅰ组。结论　PBMV在MS合并Af者中成功率高 ,再狭窄率低 ,疗效确切 ,但较窦性心律组差 ,需注意防止体循环栓塞 ,故对合并Af者更应严格病例选     

Catheter balloon valvuloplasty of stenotic aortic valves--Part II: Balloon valvuloplasty during life subsequent tissue examination.

This review describes 23 patients with aortic valve stenosis who underwent balloon valvuloplasty during life and had subsequent valve tissue examined at the time of aortic valve replacement or at necropsy. Of 23 stenotic aortic valves, 17 were examined within 30 days (early) after balloon dilation. Of these 94% had nonrheumatic (nonfused commissures) etiologies for the aortic stenosis. Of the 6 valves examined after 30 days (late) (restenosis), mechanisms of restenosis involve refusion of split commissures and probable elastic recoil. Clinical prediction of the aortic stenosis etiology prior to balloon valvuloplasty may help predict short- and long-term success of the dilation procedure.     

Single-stage balloon valvuloplasty for critical pulmonary valve stenosis in the neonate

Balloon valvuloplasty (BV) in neonates with critical pulmonary valve stenosis (CPVS) is limited by technical considerations, mainly the difficulty of traversing the stenotic valve. To simplify the procedure we used a 4F Cobra Type I catheter to cross the pulmonary valve (PV) without the aid of a guidewire, and performed single-stage BV, using low-profile balloons, in 12 neonates with CPVS. Procedure and total fluoroscopy times were 69 ± 33 min (42–125 min) and 34 ± 19 min (20–58 min), respectively. Following BV, right ventricular systolic pressure (RVSP) decreased from 102 ± 17 mm Hg to 56 ± 15 mm Hg (p < 0.001); and the ratio of RVSP to aortic systolic pressure decreased from 1.39 ± 0.22 to 0.73 ± 0.21 (p < 0.001). No significant complications were observed. BV failed in two patients, who subsequently had surgery. At follow-up (a mean of 19 months), Doppler gradient was 19 ± 12 mm Hg (0–50 mm Hg). BV was repeated in one patient. We conclude that in neonates with CPVS, the use of the 4F Cobra type I catheter facilitates crossing of the PV and allows performance of BV in a single stage; this enhances safety and time-efficiency, and shortens exposure to radiation. Cathet. Cardiovasc. Diagn. 40:322–325, 1997. © 1997 Wiley-Liss, Inc.     

Balloon dilation of critical valvar pulmonary stenosis in the first month of life

Between 1985 and 1992, 36 consecutive neonates, aged 1–29 days, weight 2.4–5.0 kg, with critical valvar pulmonary stenosis underwent attempted balloon dilation (BD). At catheterization, 30 were on prostaglandin (PGE₁) therapy and 20 were intubated. The valve was successfully crossed and dilated in 34/36 (94%), including three with an echocardiographic diagnosis of valvar pulmonary atresia and a right ventricle of adequate size. The valve was first dilated with a 2- to 5-mm balloon and then with serially larger ones (up to 12 mm) to a final balloon/annulus value of 126%. The RV/systemic pressure value fell from 150 ± 32 to 83 ± 30%, O₂ saturation rose from 91 ± 6% to 96 ± 4%, and PGE₁ was discontinued at the end of the procedure. There were 11 complications (31%) including one early death from sepsis and necrotizing enterocolitis, endocarditis in another, two myocardial perforations, one femoral-iliac vein tear, and one transient pulse loss. A repeat BD was carried out in five patients, two of whom subsequently had surgery. At follow-up (33 ± 23 months), the 31 patients managed by BD alone were well and had echocardiographic gradients of < 30 mm Hg in 90% and pulmonary regurgitation, considered mild in most, in 52%. In neonates with critical valvar pulmonary stenosis, we believe BD mortality is less than with surgery and is the treatment of choice.     

Ebstein's anomaly associated with severe valvar pulmonary stenosis: Successful palliation with balloon pulmonary valvuloplasty in an adult

We report a 52-year-old adult with Ebstein's anomaly associated with severe valvar pulmonary stenosis, secundum atrial septal defect, polycythemia, hypoxemia, and severe exertional limitations. Balloon pulmonary valvuloplasty relieved the valvar obstruction, reduced the degree of tricuspid regurgitation and polycythemia, and improved systemic oxygenation and exercise abilities. Use of this technique in patients with this combination of lesions can postpone the need for surgical intervention. Cathet. Cardiovasc. Intervent. 46:441–444, 1999. © 1999 Wiley-Liss, Inc.