Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged ≥65 and <65 years.

AIMS: To evaluate the efficacy and safety of dulaglutide 1.5 and 0.75 mg in elderly patients (aged ≥65 years) with type 2 diabetes (T2D) in six phase III clinical trials. METHODS: Patients were grouped into two age groups: ≥65 and <65 years. Pooled analysis for glycated haemoglobin (HbA1c) change from baseline, percentage of patients achieving HbA1c targets, and gastrointestinal tolerability were evaluated at 26 weeks for each dulaglutide dose. Change in weight from baseline and rates of hypoglycaemia were evaluated for each individual study. RESULTS: A total of 958 of 5171 (18.5%) patients were aged ≥65 years. The reductions in HbA1c were similar between age groups for dulaglutide 1.5 mg-treated patients {least squares [LS] mean for patients aged ≥65 years: -1.24 [95% confidence interval (CI) -1.36, -1.12] and for patients aged <65 years: -1.29 [95% CI -1.38, -1.20]} and for dulaglutide 0.75 mg-treated patients [LS mean for patients aged ≥65 years: -1.16 (95% CI -1.29, -1.03) and for patients aged <65 years: -1.10 (95% CI -1.19, -1.01)] at 26 weeks. The percentages of patients who achieved HbA1c targets of <7, <8 or <9% were also similar in the two groups with both dulaglutide doses. Patients aged ≥65 years had similar weight change to patients aged <65 years. Severe hypoglycaemic events were infrequent. A similar incidence of gastrointestinal adverse events was observed in each age group with both dulaglutide doses. CONCLUSION: Both dulaglutide doses were well tolerated, with similar efficacy in patients with T2D aged ≥65 years to those aged <65 years. Dulaglutide can be considered a safe and effective treatment option for use in older adults.

Comparative evaluation of antimicrobial efficacy of Syzygium aromaticum, Ocimum sanctum and Cinnamomum zeylanicum plant extracts against Enterococcus faecalis: a preliminary study.

AIM: To evaluate the antimicrobial efficacy of Ocimum sanctum, Cinnamomum zeylanicum, Syzygium aromaticum and 3% sodium hypochlorite (NaOCl) against Enterococcus faecalis in planktonic suspension and biofilm phenotypes. METHODOLOGY: The antibacterial efficacy of different concentrations of aqueous ethanolic extracts of O. sanctum, C. zeylanicum and S. aromaticum against E. faecalis at various time intervals was assessed using the agar well diffusion test, microdilution test and biofilm susceptibility assay (BSA) on cellulose nitrate membrane as well as in a tooth model. NaOCl was used as the positive control. Distilled water was used as negative control for agar diffusion and microdilution tests and phosphate-buffered saline for the BSA. The results of the agar diffusion test were analysed statistically using anova and Tukey's tests. RESULTS: Cinnamomum zeylanicum, S. aromaticum and O. sanctum exhibited minimum bactericidal concentration at 10%, 10% and 40%, respectively. Cinnamomum zeylanicum, S. aromaticum, O. sanctum and NaOCl showed complete bacterial inhibition in planktonic form after exposure of 30, 15, 35 and 1 min, respectively. In BSA on cellulose nitrate membrane, NaOCl was associated with complete bacterial inhibition after contact of 2 min, whilst 10% C. zeylanicum, 10% S. aromaticum and 40% O. sanctum showed cessation of growth after 12, 12 and 24 h, respectively. The results of BSA on tooth model were similar except for O. sanctum, which was not included in the model. CONCLUSION: Cinnamomum zeylanicum, S. aromaticum and O. sanctum demonstrated antimicrobial activity against planktonic and biofilm forms of E. faecalis with C. zeylanicum and S. aromaticum having better antimicrobial efficacy than O. sanctum. NaOCl had superior antimicrobial efficacy amongst all the groups.

Endoscopic assisted powered adenoidectomy versus conventional adenoidectomy - a randomised controlled trial.

OBJECTIVE: To compare endoscopic assisted powered adenoidectomy with conventional curettage adenoidectomy. METHODS: A randomised controlled trial was conducted at a tertiary care teaching hospital. Fifty patients with a symptom complex pertaining to adenoid hypertrophy and requiring adenoidectomy were chosen and divided into 2 groups of 25 each. Patients in group A underwent conventional curettage adenoidectomy and those in group B underwent endoscopic assisted powered adenoidectomy. Comparison was based on the parameters of surgical time, intra-operative bleeding, post-operative pain and completeness of adenoid removal. RESULTS: The surgical time was significantly longer with the powered instrument. Mean blood loss was greater in the powered group, but was statistically insignificant. The powered procedure fared significantly better, with lower pain scores and more instances of complete tissue resection. CONCLUSION: A curved microdebrider blade can be used safely and precisely for adenoidectomy under endoscopic vision. It enables complete resection of adenoid tissue. This method also proves to be an excellent teaching aid.

Thai adaptation and reliability of three versions of the Barratt Impulsiveness Scale (BIS 11, BIS-15, and BIS-Brief).

Long, short, and brief versions of the Barratt Impulsiveness scale (BIS-11, BIS-15, and BIS-Brief) were tested in an adult Thai population. The BIS-11T and BIS-15T were translated, back-translated, and administered to a non-clinical population (n = 305) of native Thai speakers who returned 2 weeks later for re-test. BIS-Brief-T psychometrics were calculated post-hoc. Impulsivity scores were normally distributed for the BIS-11T and BIS-15T, but not BIS-Brief-T. Excellent internal consistency was observed, with Cronbach's alpha coefficients above 0.80 for all translated instruments: BIS-11T (α = 0.86), BIS-15T (α = 0.81), BIS-Brief-T (α = 0.81). A total of 260 participants completed both instruments (85%), with test-retest reliability exceeding r = 0.81. All three instruments were highly correlated (r = 0.83-0.89). Confirmatory factor analysis supports a three factor structure (attention, motor, non-planning) for BIS-15T and two factor structure for BIS-11T. BIS scales can support measurement of a range of impulsivity scores in an adult Thai population, though predictive validity of these scales remains unexplored.

Cellular immune responses to human islet proteins in antibody-positive type 2 diabetic patients.

Type 1 diabetes is a cell-mediated autoimmune disease characterized by autoantibody and peripheral blood mononuclear cell (PBMC) reactivity to islet cell proteins. Type 2 diabetes is not an autoimmune disease but rather results from both insulin resistance and a nonautoimmune insulin secretory defect. There is, however, a group of phenotypic type 2 diabetic patients who have islet autoantibodies that are similar to those of type 1 diabetic patients. In this study, we investigated, using cellular immunoblotting, whether type 2 diabetic patients positive for islet autoantibodies have PBMC responses to islet proteins. We observed that autoantibody negative (Ab-) type 2 diabetic patients (n = 9) and normal control subjects (n = 12) demonstrated PBMCs responsive to 0-3 molecular weight regions. In contrast, autoantibody positive (Ab+) type 2 diabetic patients (n = 11) demonstrated PBMC responses to 3-18 molecular weight regions, similar to that of type 1 diabetic patients (responsive to 4-18 molecular weight regions). PBMCs from over 90% of the Ab+ type 2 and type 1 diabetic patients were observed to proliferate to islet proteins in the vicinity of 97 kDa. In contrast, 65-90% of type 1 diabetic patients had responsive PBMCs for islet proteins in most of the molecular weight regions, whereas <60% of the Ab+ type 2 diabetic patients had PBMCs responsive to the same molecular weight proteins. Ab+ type 2 diabetic patients appear to be heterogeneous with respect to cellular reactivity to islet proteins. Some subjects demonstrate PBMC responses similar to those of "classic" type 1 diabetic patients, whereas others have PBMC responses potentially distinct from type 1 diabetic patients.

Effect of serotonin and tricyclic antidepressants on intracellular calcium concentrations in Spisula oocytes.

Microspectrofluorometry and video imaging techniques were used to study and to compare the changes in intracellular calcium concentrations ([Ca2+]i) of individual Fura-2 loaded Spisula oocytes treated with serotonin (5-hydroxytryptamine, 5-HT) or tricyclic antidepressants. In the present study, we showed that 5-HT increased [Ca2+]i in freshly isolated Spisula oocytes suspended in artificial sea water. In the absence of extracellular Ca2+, 5-HT did not influence [Ca2+]i. Stimulation of [Ca2+]i by 5-HT was blocked by calcium channel blocker, e.g. verapamil, and by tricyclic antidepressants. These observations combined with our previous results on the effects of 5-HT, tricyclic antidepressants and verapamil on calcium uptake suggest that the increase in [Ca2+]i induced by 5-HT results from an influx of extracellular calcium through calcium channels, which can be blocked by tricyclic antidepressants. The use of the Fura-2 imaging technique allowed single-cell measurements and defined changes induced by 5-HT in [Ca2+]i which is the net result of calcium uptake and release of intracellular calcium from storage sites in individual Spisula oocytes.

Gastric aspiration for diagnosis of pulmonary tubercolosis in adult renal allograft recipients.

Of 213 renal allgraft recipients suspected to have had pulmonary tuberculosis, 132 had sputum examinations and 14 showed acid-fast bacilli. Of the remaining 118 patients, 25 had gastric aspirations, 18 had bronchoalveolar lavage, and 75 did not require further investigation because of spontaneous improvement or confirmation of an alternative diagnosis. While 9 of the 25 patients' gastric aspirate examination was positive, all the 18 who had bronchoalveolar lavage were negative for acid-fast bacilli. Eighty-one patients without expectoration had gastric aspiration directly and 14 showed acid-fast bacilli. Of the remaining 67 patients only 17 had bronchoalveolar lavage, of which three were positive for AFB and the rest did not require further testing for tuberculosis. A total of 106 patients had gastric aspiration. Acid-fast bacillus positivity was significantly more (P<.01) in patients with abnormal chest radiographs as compared with patients with normal chest radiographs as compared with patients with normal chest radiograph results. We suggest gastric aspiration for AFB in all renal transplant recipients who have fever, scanty expectoration, and abnormal chest radiograph with clinical suspicion of pulmonary tuberculosis.

Detection of coronary artery anomalies in tetralogy of Fallot using a specific angiographic protocol.

Patients with tetralogy of Fallot were studied with a prespecified angiographic protocol aimed to delineate the types and incidence of coronary artery anomalies and to look for any correlation with other abnormalities detected by simultaneous detailed angiography. The incidence of coronary anomalies was found to be 7.0%; no association was found with these anomalies with any of the other abnormalities detected.

Type 1 1/2 diabetes: myth or reality?

The disease process in classical Type 1 diabetes patients (IDDM) is believed to be autoimmune. In contrast, the disease process in classical Type 2 diabetes patients (NIDDM) is not autoimmune and a decreased sensitivity to insulin action is the main abnormality. The clinical distinction of Type 1 diabetes versus Type 2 diabetes is recognized to be imperfect and has limitations. There is a group of individuals (Type 1 1/2 diabetes), who present like typical NIDDM, but have some of the immunological and clinical features of IDDM. We review the current medical literature on Type 1 1/2 diabetes with special reference to its clinical characteristics, natural history and pathophysiology. Since the distinction between these two forms of diabetes may have important therapeutic implications especially with regards to the benefits of insulin therapy in patients with Type 1 1/2 diabetes and because of the need for uniformity in its diagnosis we recommend that both clinical plus biochemical criteria (the presence of ICA and/or GAD Ab, HLA typing and tests to quantify beta cell function) be used to make a diagnosis. Comparative studies in the area of cytokine production, T cell reactivity and autoantibody clustering between classic Type 1 diabetes and Type 1 1/2 diabetes patients are needed as are studies with the animal model of Type 1 1/2 diabetes, Psammomys obesus.

Fate of mild aortic valve disease after mitral valve intervention.

OBJECTIVE: This study was performed to assess the long-term outcome of untreated mild aortic valve disease present at the time of initial mitral valve intervention. METHODS: A total of 284 patients with rheumatic heart disease aged 7 to 62 years (mean, 23.5 +/- 12.2 years) who underwent mitral valve intervention and had mild aortic valve disease initially were followed up for 2 to 18 years (mean, 10.8 +/- 3.7 years). At initial intervention, 232 patients had pure mild aortic regurgitation, and 52 patients had mild aortic stenosis with or without aortic regurgitation. RESULTS: Among patients with mild aortic regurgitation initially, 11 (5%) patients progressed to moderate (n = 6) or severe (n = 5) regurgitation over an interval of 9 to 17 years (mean, 12.1 +/- 2.8 years), and 1 patient had moderate aortic stenosis and severe aortic regurgitation after 10 years. Freedom from development of moderate-severe aortic valve disease in patients who initially had mild aortic regurgitation was 100%, 97.0% +/- 1.7%, and 87.4% +/- 4.6% at 5, 10, and 15 years, respectively. Seventeen (35%) patients with initial mild aortic stenosis (with or without regurgitation) had moderate or severe stenosis (with or without moderate-severe regurgitation) after an interval of 4.9 +/- 3.8 years. Freedom from development of moderate-severe aortic valve disease in patients who initially had mild aortic stenosis was 75.6% +/- 6.2%, 61.5% +/- 8.5%, and 46.1% +/- 11.2% at 5, 10, and 15 years, respectively. Ten patients required aortic valve replacement for aortic valve dysfunction. CONCLUSIONS: Mild aortic regurgitation present at the time of mitral valve intervention progresses very slowly and less frequently requires reintervention. However, mild aortic stenosis diagnosed initially progresses more often and more rapidly and thus needs closer follow-up.

Islet cell antibodies and glutamic acid decarboxylase antibodies, but not the clinical phenotype, help to identify type 1(1/2) diabetes in patients presenting with type 2 diabetes.

This study was undertaken to determine which type 1 diabetes-associated autoantibodies and what clinical characteristics are most useful to identify patients with type 1(1/2) diabetes. We studied 125 patients, recently diagnosed clinically with type 2 diabetes for the presence of islet cell antibodies (ICA), insulin autoantibodies (IAA), antibodies to glutamic acid decarboxylase(GADAb), and IA-2a (IA-2Ab). Patients with a diagnosis of type 2 diabetes who met all of the following criteria at diagnosis were studied: age > or = 30 years, no history of ketonuria or ketoacidosis, and not requiring insulin treatment. Thirty-six patients (29%) were positive for at least 1 antibody. Thirty-two (26%) were ICA positive and 20 (16%) GADAb positive. Insulin autoantibodies and IA-2Ab occurred less frequently in 2 (1.6%) and 8 (6.4%) patients, respectively. There was no significant difference in the ages at diagnosis between the Ab(+) and Ab(-) patients, age in years (range) 47.2 (32 to 64) versus 51.2 (31 to 77), respectively, P =.06. Body mass index (BMI) was different in the 2 groups, with Ab(+) patients being less obese, BMI (range) 28.3 kg/m(2) (17.6 to 54.9) versus 32.0 kg/m(2) (19.2 to 68.8), respectively, P =.01. Clinical presentation of diabetes was more commonly symptomatic with polyuria and polydipsia in Ab(+) patients, while in Ab(-) patients, diagnosis was more often incidental, P =.002. However, more than 95% of patients overlapped in both age and BMI irrespective of antibody status. Similarly, 42% of Ab(+) patients had their diabetes diagnosed incidentally, while 29% of Ab(-) patients presented with polyuria and polydipsia. We therefore conclude that screening with antibodies, mainly ICA and GAD, but not age, BMI, or clinical presentation should be used to identify type 1(1/2) diabetes.

Mammary-coronary artery anastomosis without cardiopulmonary bypass through a minithoracotomy.

BACKGROUND: Coronary artery bypass grafting has been based on cardiopulmonary bypass, myocardial protection, and the median sternotomy. The recent concept of minimally invasive coronary artery bypass grafting in selected patients has dramatically affected surgical management of coronary artery disease. Coronary artery bypass grafting of anterior coronary arteries with in situ internal mammary artery through a limited anterior thoracotomy is a procedure that is gaining acceptance. METHODS: Fifty-one patients were operated on by minithoracotomy and direct coronary artery bypass grafting without cardiopulmonary bypass. Left internal mammary artery-to-left anterior descending coronary artery anastomosis was done in 50 patients, and in 1 patient, left internal mammary artery-to-left anterior descending artery and right internal mammary artery-to-right coronary artery anastomoses were constructed through bilateral minithoracotomies. Left anterior minithoracotomy through the fourth intercostal space and right anterior minithoracotomy through the fifth intercostal space were used for left internal mammary artery and right internal mammary artery dissection, respectively. With this approach, a 4- to 6-cm length of mammary artery was easily dissected. Mammary-to-coronary anastomosis was performed on a beating heart without cardiopulmonary bypass through window pericardiotomy. RESULTS: Twenty-five patients were extubated in the operating room and 26 in the intensive care unit 4 to 6 hours after operation. None of these patients required blood transfusion or inotropic support. Postoperative predischarge angiography in 42 patients revealed adequate mammary-to-coronary flow in 40 patients. Doppler flow studies were also in accordance with angiographic findings. Forty-five patients are in our regular follow-up (mean follow-up, 6.23 +/- 1.34 months); 44 of them are in functional class I. CONCLUSION: In our experience minithoracotomy is a safe, simple, and minimally invasive procedure. Favorable cost/benefit ratio has been achieved owing to no early or late mortality and minimal early morbidity. Postoperative angiography and Doppler flow study revealed excellent predictive long-term results.

Univentricular repair: is routine fenestration justified?

BACKGROUND: A decade after the introduction of baffle fenestration, the outcome of Fontan-type repair for hearts with a functional single ventricle finally looks promising. Our study was designed to assess the impact of fenestration on the outcome of univentricular repairs. METHODS: From January 1988 to December 1997, 348 patients (104 with tricuspid atresia and 244 with other morphological diagnoses) underwent univentricular repair at our institute. Since 1994, routine fenestration of the atrial baffle was performed in all patients (n = 126). RESULTS: The overall Fontan failure rate was 14% (50 of 348) and included 45 early deaths and five Fontan take downs. Absence of fenestration was the only and highly significant predictor of Fontan failure (risk ratio [RR] 3.3, 95% confidence interval [CI] 1.49 to 7.31, p = 0.002). Significant pleural effusion was seen in 27% of patients. Absence of fenestration of the atrial baffle (RR 3.97, 95% CI 2.17 to 7.26, p < 0.001) and aortic cross-clamp time more than 60 minutes (RR 2.15, 95% CI 1.3 to 3.5, p = 0.002) were found to be significant risk factors. The follow-up ranged from 6 to 120 months (mean 46.0 +/- 18.0 months). There were 12 late deaths and 5 patients were lost to follow-up. Actuarial survival (Kaplan Meier) at 90 months was 81% +/- 4%. Two hundred and fifty-eight patients (90%) were in New York Heart Association class I at their last follow-up visit. Oxygen saturation in the fenestrated group ranged from 85% to 94% (mean 89%). Thirty patients (26%) had spontaneous closure of the fenestration over a mean period of 34 months, and there has been no incidence of late systemic thromboembolism. In no instance has there been a need to close the fenestration. CONCLUSIONS: Elective fenestration of the intraatrial baffle is associated with decreased Fontan failure rate and decreased occurrence of significant postoperative pleural effusions. Routine elective fenestration of the atrial baffle may, therefore, be justified in all univentricular repairs.

Repair of total anomalous pulmonary venous connection in infancy: experience from a developing country.

BACKGROUND: Corrective surgery for total anomalous pulmonary venous connection in infancy still carries high morbidity and mortality rates in developing countries. The present study evaluates the factors responsible for it. METHODS: Seventy-three infants were operated on for total anomalous pulmonary venous connection from January 1987 through October 1997. Age ranged from 5 days to 12 months (mean, 3.9+/-0.24 months), with 10 (13.7%) patients younger than 1 month old. Patient weight varied from 2.0 to 5.2 kg (mean, 3.7+/-0.27 kg). Most (90.5%) patients were small for their ages (< 50th percentile). Anomalous connection was supracardiac in 42 (57.5%), cardiac in 18 (24.7%), infracardiac in 4 (5.5%), and mixed in 9 (12.3%) patients. Thirty-five patients had obstructed drainage. Preoperatively, 30 patients received antibiotic therapy for respiratory tract infection, 3 patients had balloon atrial septostomy, and 4 patients required mechanical ventilation. Fifteen patients (20.5%) were operated on as an emergency procedure. For supracardiac and infracardiac connections, a posterior approach was used for anastomosis. In cardiac type, coronary sinus was unroofed and the resultant defect along with atrial septal defect was closed with a single patch. RESULTS: The operative mortality rate was 23.3% (17 of 73). Pulmonary hypertensive crisis was the cause of death in 10 patients. Emergency operation and weight less than the 25th percentile were the important risk factors for operative mortality. Young age (< 1 month) and type of drainage did not affect the mortality. Follow-up ranged from 1 to 108 months (mean, 56.4+/-26.0 months). There were two late deaths. The actuarial survival (Kaplan Meier) at 9 years was 72.87%+/-5.39%. CONCLUSION: Failure of early recognition, and thus delayed referral, accounted for onset of cardiac cachexia, respiratory tract infection, and severe pulmonary hypertension, which had a major effect on unfavorable outcome.

Regulation of serotonin-induced calcium uptake in Spisula oocytes by tricyclic antidepressants.

The effect of tricyclic antidepressants on 5-hydroxytryptamine (serotonin or 5-HT)-induced maturation and Ca2+ uptake in Spisula oocytes was determined. The drugs at a concentration of 20 microM completely blocked germinal vesicle breakdown and 45Ca2+ uptake by Spisula oocytes. The order of effectiveness of the antidepressants were imipramine > desipramine > clomipramine. The present findings suggest that the action of tricyclic antidepressants is to regulate Ca2+ uptake into 5-HT-responsive cells.

Sequence divergence within the sperm-specific polypeptide TCTE1 is correlated with species-specific differences in sperm binding to zona-intact eggs.

The T-complex-associated testes-expressed (TCTE1) gene encodes a novel sperm cell-specific polypeptide (TCTE1) that is conserved across vertebrate species. TCTE1 is absolutely required for fertilization and is expressed in earlier stages of spermatogenesis. When the amino acid sequence of the TCTE1 gene product is compared among various mammalian species, a large, highly conserved domain is observed, along with a divergent domain encoding the 56-58 residues at the N terminus. In this study, the N-terminal regions of the TCTE1 polypeptide from three rodent species--mouse, gerbil, and rat--were compared. The results show that while the gerbil and mouse species are most distant in evolutionary terms, their TCTE1 homologs have not undergone significant divergence. In contrast, the N-terminal region of the rat TCTE1 homolog has evolved rapidly, a finding that indicates positive Darwinian selection. We have tested the correlation between TCTE1 divergence and heterospecific sperm-egg binding ability in the three species under study. Gerbil sperm bind to mouse eggs, while no significant binding is observed between rat sperm and mouse eggs. The results obtained support the hypothesis that the sperm-specific polypeptide TCTE1 may facilitate species-specific divergence of sperm function.

Abnormal exercise electrocardiogram in an asymptomatic person--what next?

No reasonable guidelines exist for evaluating an asymptomatic individual (without evidence for ischemic heart disease on history or electrocardiography) with a positive exercise ECG. Available data indicate that persons with a strongly positive test should undergo a coronary angiography. In persons with mild to moderately positive results, cinefluoroscopy is indicated and those who show coronary calcification should have a coronary angiogram. Although stress thallium-201 is often done before coronary angiography, its role is limited. Scant data exist in women and suggest that the overall approach may not be markedly different. However, ST changes in women have a low specificity. Recent studies indicate a 95% specificity and sensitivity for positron emission tomography. Despite its high costs it may still be the most cost-effective modality by saving unwanted radionuclide studies and arteriographies.

Concurrent aortic and mitral balloon valvuloplasty by the retrograde non-transseptal technique.

Balloon valvuloplasty for combined aortic and mitral stenosis is now being increasingly practised. Transseptal catheterisation forms an integral part of this procedure. We describe a case where the retrograde non-transseptal approach was used for dilating both valves in a single intervention.

Factors influencing late course of residual valvular and infundibular gradients following pulmonary valve balloon dilatation.

BACKGROUND: Though acute and follow-up benefits of pulmonary valve balloon dilatation (PVBD) for pulmonic valve stenosis are well known, the late course of residual gradients at individual valvular and infundibular levels is not well described. Furthermore, the factors influencing this late course have not been studied. MATERIALS AND METHODS: We assessed the transpulmonary gradients by echo-Doppler in 96 patients (61 male, mean age 10.7 years) at a mean follow-up interval of 58.8+/-32.1 months (minimum 2 years) following PVBD. The patients were divided into three groups based on the residual gradients at valvular and infundibular levels immediately following PVBD as assessed by pull-back of an end-hole catheter across the right ventricular outflow tract: Group A with minor pressure gradients at both valvular and infundibular levels of less than 30 mmHg (n=60, 62.5%), Group B with predominantly infundibular gradients of more than 30 mmHg with a valvular gradient of less than 30 mmHg (n=27, 28.1%), and Group C with a residual valvular gradient of greater than 30 mmHg irrespective of the infundibular gradient (n=9, 9.4%). Demographic characteristics, hemodynamic parameters and procedural variables were correlated with the change in gradient at follow-up (late fall) and with long-term results. RESULTS: The mean follow-up trans-pulmonary gradient was 20+/-14 mmHg which was significantly lower than that immediately post-PVBD (43+/-32 mmHg), P<0.001. The late fall (mean 24+/-29, range -55 to 110 mmHg) varied widely depending upon the acute result group: patients in Groups A and B showed significant late fall of 9+/-12 mmHg (P<0.05 for follow-up gradient compared to that following PVBD) and 58+/-31 mmHg (P<0.0001), respectively, while patients in Group C showed an insignificant late fall of 14+/-37 mmHg (P=0.21). In particular, each one of the patients in Group B showed decrease in trans-pulmonary gradients. On multivariate analysis, the extent of infundibular gradient emerged as the most important predictor of late fall (coefficient of determination 75%, P<0.0001). Patients who underwent PVBD at less than 2 years of age had a significantly greater late fall (41+/-33 mmHg) as compared to older patients (22+/-25 mmHg), P<0.05. A sub-optimal long-term result (transpulmonary gradient >25 mmHg, n=24) was significantly related to older age (P<0.001), dysplastic valve morphology (P=0.002), greater baseline trans-pulmonary gradients (P<0.001) and higher post-PVBD gradients (P=0.04). CONCLUSIONS: The long-term course of patients following PVBD depends upon the site and magnitude of the residual gradients. Even high residual infundibular gradients show marked reduction at follow-up, especially in infancy.