Compare CPM-RMI trial: intramyocardial transplantation of autologous bone marrow-derived cd133+ cells and mononuclear cells during coronary artery bypass grafting in patients with recent myocardial infarction: a phase II/III, multicenter, placebo-controlled, randomized, double-blind clinical trial

Objective: The regenerative potential of bone marrow-derived mononuclear cells [MNCs] and CD133+ stem cells in the heart varies in terms of their pro-angiogenic effects. This phase II/III, multicenter and double-blind trial is designed to compare the functional effects of intramyocardial autologous transplantation of both cell types and placebo in patients with recent myocardial infarction [RMI] post-coronary artery bypass graft

Materials and Methods: This was a phase II/III, randomized, double-blind, placebo-controlled trial COMPARE CPM-RMI [CD133, Placebo, MNCs - recent myocardial infarction] conducted in accordance with the Declaration of Helsinki that assessed the safety and efficacy of CD133 and MNCs compared to placebo in patients with RMI. We randomly assigned 77 eligible RMI patients selected from 5 hospitals to receive CD133+ cells, MNC, or a placebo. Patients underwent gated single photon emission computed tomography assessments at 6 and 18 months post-intramyocardial transplantation. We tested the normally distributed efficacy outcomes with a mixed analysis of variance model that used the entire data set of baseline and between-group comparisons as well as within subject [time] and group×time interaction terms

Results: There were no related serious adverse events reported. The intramyocardial transplantation of both cell types increased left ventricular ejection fraction by 9% [95% confidence intervals [CI]: 2.14% to 15.78%, P=0.01] and improved decreased systolic wall thickening by -3.7 [95% CI: -7.07 to -0.42, P=0.03]. The CD133 group showed significantly decreased non-viable segments by 75% [P=0.001] compared to the placebo and 60% [P=0.01] compared to the MNC group. We observed this improvement at both the 6- and 18-month time points

Conclusion: Intramyocardial injections of CD133+ cells or MNCs appeared to be safe and efficient with superiority of CD133+ cells for patients with RMI. Although the sample size precluded a definitive statement about clinical outcomes, these results have provided the basis for larger studies to confirm definitive evidence about the efficacy of these cell types

PFAPA and 12 common MEFV gene mutations our clinical experience

Marshall Syndrome or PFAPA is an inflammatory periodic disease characterized by periodic fever, aphthous stomatitis, pharyngitis and cervical adenitis. Although PFAPA is an auto inflammatory disease, it doesn't have genetic basis such as other periodic fevers. This study evaluates the 12 common MEFV gene mutations in patients with PFAPA syndrome. 21 patients with PFAPA syndrome who had diagnostic criteria were enrolled in this study and 12 common MEFV gene mutations i.e. P369S, F479L, M680I [G/C], M680I [G/A], I692del, M694V, M694I, K695R, V726A, A744S, R761H, E148Q evaluated. All the patients were screened for MEFV gene mutations by a reverse hybridization assay [FMF Strip Assay, Vienna lab, Vienna, Austria] according to the instructions provided by the manufacturer. The age of patients was between 6 months to 14 years, and 15 were males. Seven patients had heterozygote and one had compound heterozygote [K695R, V725A] mutation. There were 4 alleles M694V, 3 alleles V726A, 1 allele E148Q and 1 allele K694R. No significant difference existed between mutated patients with non-mutated in symptoms like aphthous and stomatitis, duration of attacks, episodes of fever and response to treatment. Gaslini score test was not helpful to predict the probability of gene mutations. About 30 percent of patients had MEFV gene mutations but these mutations did not play a main role in presentation of PFAPA symptoms

Diagnostic value of electrocardiography compared with echocardiography in measuring left ventricular mass index in major thalassemia patients over 10 years of age

Patients suffering from major beta thalassemia need frequent blood transfusions and, if not treated well, would be at risk of heart dysfunction. This study was performed to determine the diagnostic value of electrocardiography versus echocardiography in measuring the left ventricular mass index in these patients. Between July 2010 and June 2011, 82 asymptomatic patients over 10 years of age with major thalassemia [42 men with a mean age of 17.65 +/- 3.39 years and 40 women with a mean age of 16.9 +/- 3.38 years] were enrolled in this study. For all the patients, standard electrocardiography [to measure R in aVL and S in V3 and calculate left ventricular mass index by electrocardiography] and echocardiography [to measure interventricular septum diameter in diastole, left ventricular posterior wall diameter in diastole, and left ventricular diameter in diastole in order to calculate left ventricular mass index by echocardiography] were performed, at least one week after transfusion. The calculated left ventricular mass indices were thereafter compared between the two methods [electrocardiography and echocardiography]. Sensitivity, specificity, positive predictive value, and negative predictive value in the two techniques in determining the left ventricular mass index were 67%, 25%, 89%, and 7% in the females, 65%, 33%, 92%, and 6% in the males, and 67%, 14%, 89%, and 3% in the total population, respectively. Furthermore, this study demonstrated that the average left ventricular mass index by echocardiography and electrocardiography was 104.86 +/- 21.65 gr/m[2] and 91.69 +/- 12.03 gr/m[2], respectively. Echocardiography was much more accurate than electrocardiography in determining the left ventricular mass index [p value = 0.0001]. The findings of this study demonstrated that echocardiography was more accurate and more reliable than electrocardiography in determining the left ventricular mass index in major thalassemia patients

Impact of intact pleura during left internal mammary artery harvesting on clinical outcome

Pleurotomy during coronary artery bypass grafting [CABG] may cause post-operative events, mostly pulmonary complications. In this study, we evaluated the influence of pleurotomy during CABG on the clinical outcome following left internal mammary artery [LIMA] harvesting. Between March and August 2009, 102 patients who underwent cardiac surgery were enrolled in this study and divided into two groups: group A [n = 48, 36 male and 12 female patients at a mean age of 56.5 +/- 11.2 years] underwent routine CABG and pleurotomy and group B [n = 54, 46 male and 8 female patients at a mean age of 55.4 +/- 10.3 year] had CABG with intact pleura. The patients were compared regarding their demographic data, surgical data, and postoperative events. The incidence of postoperative pericardial effusion was similar between the groups, but the incidence of postoperative pulmonary complications such as pleural effusion [except for mildpleural effusion] on the second [no: 10.4%, mild: 41.7%, moderate: 45.8% and severe: 2.7% in group A versus no: 42.6%, mild: 44.4%, moderate: 13%, and severe: 0 in group B] and fifth postoperative days [no: 27.1%, mild: 33.3%, moderate: 35.4%, and severe: 4.2% in group A versus no: 42.6%, mild: 44.4%, moderate: 13%, and severe: 0 in group B] was significantly lower in group B [p value < 0.001 and p value = 0.007, respectively]. Also, the incidence of atelectasis [except for mild atelectasis] on the second [no: 2.1%, mild: 22.9%, moderate: 72.9%, and severe: 2.1% in group A versus no: 9.2%, mild: 59.3%, moderate: 31.5%, and severe: 0 in group B] and fifth postoperative days [no: 22.9%, mild: 39.6%, moderate: 35.4%, and severe: 2.1% in group A versus no: 39.6%, mild: 49.1%, moderate: 11.3%, and severe: 0 in group B] was significantly higher in group A [p value < 0.001 and p value = 0.004, respectively]. Postoperative partial oxygen pressure and 02 saturation were similar between the groups, but partial carbon dioxide pressure was significantly lower in group A [p value = 0.017]. Amount of bleeding [p value = 0.008] and duration ofhospitalization [p value =0.002] were significantly higher in group A than those in group B. Our results indicate that keeping the pleura intact has beneficial effects on the respiratory function, without increasing the incidence of postoperative pericardial effusion

Relationship between gender and in-hospital morbidity and mortality after coronary artery bypass grafting surgery in an Iranian population

Many previous studies have investigated the influence of gender on coronary artery bypass grafting surgery [CABG] outcomes. Despite the great volume of reports on this issue, it is still not clear whether it is the gender of the patient or pre-existing comorbid conditions that is the best predictor for the different outcomes seen between men and women. Multiple studies have shown that women are at higher risk of postoperative complications than men, particularly in the perioperative period. The goal of this study was to determine whether sex differences exist in preoperative variables between men and women, and to evaluate the effect of gender on short-term mortality and morbidity after CABG in an Iranian population. Data were collected prospectively from 690 consecutive patients [495 men and 195 women] who underwent isolated CABG. Preoperative, intraoperative, and postoperative variables, major complications and death were compared between the male and female patients until hospital discharge using multivariate analysis. Women were older [P = 0.020], had more diabetes [P = 0.0001], more obesity [P = 0.010], a higher New York Heart Association functional class [P = 0.030], and there was less use of arterial grafts [P = 0.016]. Men had more tobacco smokers [P = 0.0001] and lower preoperative ejection fractions [EF] [P = 0.030]. After surgery, women had a higher incidence of respiratory complications [P = 0.003], higher creatine kinase [CK] - MB levels [P = 0.0001], and higher inotropic support requirements [P = 0.030]. They also had a higher incidence of decreased postoperative EF versus preoperative values [P = 0.020]. The length of ICU stay, incidence of return to ICU and postoperative death, were similar between men and women. Nevertheless, after adjusting for age and diabetes, female gender was still independently associated with higher morbidity in patients over 50 years of age. Women had more risk factors, comorbidities, and postoperative complications. Women older than 50 years of age were at a higher risk of postoperative complications than men. This difference decreased with younger age. In-hospital mortality rates were not influenced by sex, as there was no difference found between the two groups [2.5% women vs. 2.2% men; P > 0.05]

Very late effects of postoperative atrial fibrillation on outcome of coronary artery bypass graft surgery

Atrial fibrillation [AF] after coronary artery bypass graft [CABG] is a common complication with potentially higher risk of adverse outcome and prolonged hospital stay. To determine the impact of postoperative AF [POAF] on long-term outcome in a large cohort of patients who underwent CABG. We conducted an observational cohort study of 989 patients who underwent isolated CABG with more than 5-year follow-up. Patient divided in two groups: patients with and without POAF. In this study, atrial fibrillation developed after CABG in 156 patients [15.8%]. Patients with POAF were generally older [P = 0.001] and presented more often with comorbidities including congestive heart failure [P = 0.001], hypertension [P = 0.001], peripheral vascular disease [P = 0.001], hyperlipidemia [P = 0.009], and renal failure [P = 0.001]. Five-year mortality was observed in 23 [2.3%] patients. Patients with POAF had higher five-year mortality rate than those without POAF. Multivariate logistic analysis showed that AF after surgery has a strong effect on mortality [HR, 3.3; 95% CI, 0.04-10.8, P = 0.04] and morbidity rates [HR, 4.0; 95% CI, 2.35-6.96, P = 0.001]. Postoperative atrial fibrillation strongly predicts higher long-term mortality and morbidity following coronary artery bypass graft

Partially unroofed coronary sinus with intact atrial septum in an elderly patient

We present a very rare case of partially unroofed coronary sinus without persistent left superior vena cava in a 74 years old female with a history of hypertension, severe myxomatous bileaflet mitral valve prolapse with severe eccentric mitral regurgitation which was diagnosed during cardiac surgery

Pregnancy outcome after mechanical mitral valve replacement: a prospective study

Pregnant patients with mechanical heart valves require anticoagulation. The risk of bleeding and embryopathy associated with oral anticoagulants must be weighed against the risk of valve thrombosis. In this prospective study, undertaken between 1999 and 2009, 53 pregnancies [47 women with mechanical mitral valves; 29.8 +/- 4.8 years old] were studied. Patients were divided into two groups: group I [n = 43] received Warfarin throughout the pregnancy, while group II [n = 10] received Heparin in the first trimester and then Warfarin until the 36th week. Thirty-two [60.4%] pregnancies resulted in live births, whereas 18 [34%] abortions, 2 [3.8%] stillbirths, and one [1.9%] maternal death occurred. In group I, there were 26 [60.5%] live births, one [2.3%] stillbirth, and 15 [34.9%] abortions. In group II, there were 6 [60%] live births, one [10%] stillbirth, and 3 [30%] abortions. There were no significant differences between the two groups in terms of fetal outcome. Thirty-nine [90.7%] of the pregnancies in group I and 50% of those in group II [p value = 0.001] were without complications. There were no congenital malformations in the two groups. Fetal outcome was almost the same between the Warfarin and Heparin regimens. In maternal outcome, the Warfarin regimen is safer than Heparin

Hydatid cyst mimicking heart tumor

We present two women who lived in a rural community. The presence of a semi-solid mass, a hydatid cyst or tumor, in the heart was diagnosed by echocardiography, computed tomography, and Magnetic Resonance Imaging. The hydatid cyst was seen during surgery. Pathological examination confirmed an infected hydatid cyst

Pseudoaneurysm of ascending aorta with fistulization to left atrium after coronary artery bypass graft surgery

A 53-year-old man with a history of coronary artery bypass graft surgery 4 years previously was admitted to our hospital with dyspnea on exertion [New York Heart Association class II] of three months' duration, lower extremities edema of two weeks' duration, and pulmonary edema of two weeks' duration. Transthoracic and transesophageal echocardiographic examinations revealed pseudoaneurysm of the ascending aorta with fistulization to the left atrium. He was, therefore, scheduled for surgery, during which repair of the ascending aorta with a pericardial patch in conjunction with repair of the aortic valve and removal of the fistulization between the left atrium and ascending aorta was performed. The patient was discharged ten days after admission in very good physical condition. Postoperative echocardiography demonstrated only mild aortic regurgitation and no residual connection between the left atrium and ascending aorta, with the latter having a normal size

Anti-coagulation during pregnancy in women with mechanical heart valves: a prospective study

Pregnancy is associated with a hypercoagulable state, therefore the optimal anticoagulants for potential use in pregnant women with prosthetic heart valves are controversial. The aim of this study is to investigate the effect of anticoagulants on pregnancy outcomes and their potential risks in pregnant women with mechanical heart valves. In this prospective cohort study, we followed 44 women with 49 pregnancies who had mechanical heart valves from September 2002 to September 2007. A total of 38 patients took warfarin throughout their pregnancies [group A]. In 11 patients, warfarin was changed to heparin during the first trimester and then again to warfarin during 12[th] to 36[th] weeks of gestational age [group B]. All women took warfarin from 36[th] weeks of gestational age until deliver. In group A, there were 22 live births [57.9%], 15 abortions [39.5%] and 1 maternal death [2.6%]. In group B, there were seven live births [63.6%], three spontaneous abortions [27.3%] and one intra-uterine fetal death [9.1%]. There was no significant difference in live birth rate between the two groups [p=0.24]. Thirty-three pregnancies [86.8%] in group A and five pregnancies [45.4%] in group B had no maternal complications [p=0.004]. The difference in pregnancy complications between both groups was significant [p<0.001]. The present study shows that low dose warfarin [5 mg/day or less] may be safe during the first trimester of pregnancy. Maternal adverse events are low when pregnant women with mechanical heart valves remain on a warfarin regimen. The risk of embryopathy doe not necessarily increase

Fungal endocarditis: review of our cases over a four-year period

Over a 4-year period, we studied six cases of fungal endocarditis, four of which were caused by Aspergillus sp. And the other two were candidal in origin. Both sides of the heart showed involvement by these infections. The vegetations of infective endocarditis tend to vary in size, but fungal lesions are often large. Our youngest patient was four months old and the oldest one was 62 years old. A high index of clinical suspicion, together with histopathological and microbiological studies, can be used as tools to diagnose and treat such patient in due course. It is important to send fresh specimens for tissue culture studies in sterile normal saline and not in fixatives such as formaladehyde. Pathologically, not only are the special staining methods such as Periodic acid-Schiff useful in the demonstration of fungal elements in tissue or vegetation sections, but also the routine hematoxylin and eosin stain is capable of showing these structures clearly

Post-surgical right ventricular pseudoaneurysm presenting as and epigastric pulsatile mass

We report a case of right ventricular pseudoaneurysm three weeks after open mitral valve commissurotomy. Transthoracic echocardiography showed a cavity of approximately 5 x 3 cm contiguous to the right ventricular inflow, communicating with the right ventricle by a small neck. Doppler study showed the presence of systolic and diastolic flow at the site of the rupture. Pseudoaneurysm is an infrequent surgical complication involving right ventriculotomy and often increases progressively in size. The association with open mitral valve commissurotomy has not been previously reported

Anterior leaflet augmentation: an effective method to repair tricuspid valve regurgitation

As an invaluable surgical tool, autologous pericardium has been successfully used to repair many cardiac lesions. The encouraging results from its use in repairing heart valves have been applied to repair tricuspid valve regurgitation [TR]. In the present study, we report our preliminary results using autologous pericardium as an alternative surgical technique in repairing tricuspid valve insufficiency. From June 2002 to November 2006, 22 patients [mean age 39.7 years] with heart valve disease underwent tricuspid valve repair by anterior leaflet augmentation with glutaraldehydetreated autologous pericardium. Nineteen patients [86.4%] had pure tricuspid valve regurgitation [TR], while the remaining three patients [13.6%] had significant associated tricuspid valve stenos is in whomcommissurotomy was carried out. TR was considered severe in 18 patients and moderate to severe in four cases. All had associated left-sided heart valve surgery, except two patients. Concomitant adjustable tricuspid annuloplasty by pericardial band was performed in 12 patients. The mean follow-up period was 10.39 months [range 1 to 42 months]. There was one in-hospital death due to postoperative multiorgan failure. One patient developed partial detachment of the pericardial patch, which was successfully repaired. Echocardiography data showed a significant decrease in the severity of TR: trivial to mild in 68.2% [n=15], mild to moderate in 22.7% [n=5], and moderate to severe in 9.1% [n=2] of the patients. Anterior tricuspid leaflet augmentation is a safe, effective and appealing surgical technique in dealing with patients with tricuspid valve regurgitation. Further studies are, however, mandatory to evaluate its long-term outcome

Atrial septal aneurysm concomitant with severe mitral stenosis

An atrial septal aneurysm is an uncommon abnormality and may be the origin of thromboembolic events. We herein present an unusual case of this septal abnormality with mitral stenosis and history of thromboembolic cerebrovascular accident