Paulo Sergio de Oliveira

A safety and feasibility study of cell therapy in dilated cardiomyopathy

The aim of this study was to determine if bone marrow mononuclear cell (BMMC) transplantation is safe for moderate to severe idiopathic dilated cardiomyopathy (IDC). Clinical trials have shown that this procedure is safe and effective for ischemic patients, but little information is available regarding non-ischemic patients. Twenty-four patients with IDC, optimized therapy, age 46 ± 11.6 years, 17 males, NYHA classes II-IV, and left ventricular ejection fraction <35% were enrolled in the study. Clinical evaluation at baseline and 6 months after stem cell therapy to assess heart function included echocardiogram, magnetic resonance imaging, cardiopulmonary test, Minnesota Quality of Life Questionnaire, and NYHA classification. After cell transplantation 1 patient showed a transient increase in enzyme levels and 2 patients presented arrhythmias that were reversed within 72 h. Four patients died during follow-up, between 6 and 12 weeks after therapy. Clinical evaluation showed improvement in most patients as reflected by statistically significant decreases in Minnesota Quality of Life Questionnaire (63 ± 17.9 baseline vs 28.8 ± 16.75 at 6 months) and in class III-IV NYHA patients (18/24 baseline vs 2/20 at 6 months). Cardiopulmonary exercise tests demonstrated increased peak oxygen consumption (12.2 ± 2.4 at baseline vs 15.8 ± 7.1 mL·kg⁻¹·min⁻¹ at 6 months) and walked distance (377.2 ± 85.4 vs 444.1 ± 77.9 m at 6 months) in the 6-min walk test, which was not accompanied by increased left ventricular ejection fraction. Our findings indicate that BMMC therapy in IDC patients with severe ventricular dysfunction is feasible and that larger, randomized and placebo-controlled trials are warranted.

Percutaneous Mitral Balloon Valvotomy. Long-term Outcome and Assessment of Risk Factors for Death and Major Events

OBJECTIVE To identify the factors that predict death and combined events, (death, new mitral balloon valvotomy, or mitral valve surgery) in long-term follow-up of patients undergoing percutaneous mitral balloon valvotomy. METHODS Follow-up was 49.0+/-31.0 (1 to 122) months. Techniques used were the single-balloon (84.4%), Inoue-balloon (13.8%), and double-balloon techniques (1.7%). RESULTS Included in the study were 289 patients 38.0+/-12.6 years of age (range, 13 to 83). Before the procedure, 244 patients had echocardiographic score < or = 8, and 45 patients had score > 8. Females comprised 85%, and 84% patients were in sinus rhythm. During follow-up, survival of the total group was 95.5%, that of the group with < or = 8 was 98.0%, finally that of the group with scores > 8 was 82.2% (P < 0.0001), whereas combined event-free survival was 83.4%, 86.1%, and 68.9%, respectively (P < 0.0001). In the multivariate analysis, the factors that predicted long-term death were a preprocedure echocardiographic score > 8 and the presence of severe valvular mitral regurgitation during the procedure. The events that predicted combined events were a previous history of mitral valvular commissurotomy and atrial fibrillation and the presence of severe mitral valvular regurgitation during the procedure, and postprocedure mitral valvular area < 1.5 m2 (failure). CONCLUSION Percutaneous mitral balloon valvotomy is an effective procedure, and over 2/3 of the patients were event-free at the end of follow-up. Survival in the group was high, even higher in the group with lower echocardiographic scores.

Cell therapy in dilated cardiomyopathy

A forty-one-year-old male with systolic heart failure, FC-III NYHA, clinical stage C due to dilated cardiomyopathy was submitted to an autologous transplant of the mononuclear fraction of bone marrow via coronary artery system through heart catheterism. Two months after the procedure, there was a decrease in plasma BNP and cardiac area reduction at the thorax X-ray and nuclear magnetic resonance. The echocardiogram showed decrease of the secondary regurgitation and mitral ring dilatation. There was a better performance at the ergospirometry, with increase of the maximum oxygen consumption and consequent reduction in drug therapy. The absence of adverse events characterized by clinical/hemodynamic instability, enzymatic alteration or electrocardiogram demonstrate the safety and feasibility of this procedure carried out and described with pioneering spirit in dilated cardiomyopathy.

Balão único versus balão de Inoue na valvoplastia mitral percutânea por balão. Resultados imediatos e complicações

PURPOSE: To assess short-term results and complications of percutaneous mitral balloon valvuloplasty (PMBV) performed with Inoue balloon (IB) and single low profile balloon (SB). METHODS: We performed 390 PMBV procedures, 29 with IB and 337 with SB . There were no differences in age, sex, echocardiographic score distribution and echocardiographic mitral valve area (MVA). RESULTS: We performed 29 complete procedures with IB and 330 of 337 in SB group. Comparing IB and pre and pos-PMBV data we obtained: mean pulmonary artery pressure (MPAP) 36±15 and 39±14mmHg, p=0.2033, mean mitral gradient 17±6 and 20±7mmHg, p=0.0396 and MVA 0.9±0.2 and 0.9±0.2cm2, p=0.8043 and pos-PMBV: MPAP 25±8 and 28±10mmHg, p=0.2881, gradient 5±3 and 5±4mmHg, p=0.2778 and MVA 2.2±0.2 and 2.0±0.4cm2, p=0.0362. Mitral valve (MV) was competent in 26 patients in IB and in 280 in SB group and we had +/4 mitral regurgitation in 3 patients in IB and in 57 in SB group (p=0.3591) pre-PMBV respectively and pos-PMBV there was also no difference in MV competence (p=0.7439). CONCLUSION: Both techniques were effective. Hemodynamic data were also similar although MVA was greater in IB group after PMBV.

Influence of the echocardiographic score and not of the previous surgical mitral commissurotomy on the outcome of percutaneous mitral balloon valvuloplasty

OBJECTIVE To evaluate prior mitral surgical commissurotomy and echocardiographic score influence on the outcomes and complications of percutaneous mitral balloon valvuloplasty. METHODS We performed 459 complete mitral valvuloplasty procedures. Four hundred thirteen were primary valvuloplasty and 46 were in patients who had undergone prior surgical commissurotomy. The prior commissurotomy group was older, had higher echo scores, and a tendency toward a higher percentage of atrial fibrillation. RESULTS When the groups were compared with each other, no differences were found in pre- and postprocedure mean pulmonary artery pressure, mean mitral gradient, mitral valve area, and mitral regurgitation. Because we found no significant differences, we subdivided the entire group based on echo scores, those with echo scores < or =8 and those with echo scores >8 the mitral valve area being higher in the < or =8 echo score group 2.06+/-0.42 versus 1.90+/-0.40 cm2 (p=0.0090) in the >8 echo score group. CONCLUSION Dividing the groups based on echo score revealed that the higher echo score group had smaller mitral valve areas postvalvuloplasty.

[Balloon valvuloplasty outcome of a group previously submitted to mitral percutaneous or surgical valve repair versus first-time valvuloplasty patients. Evolution of the group previously submitted to valve repair procedures].

OBJECTIVE To evaluate 501 procedures of mitral balloon valvuloplasty and the differences among the group already submitted the prior surgical or balloon valvuloplasty, with 59 procedures and the group without previous intervention, with 442 procedures. METHODS It was used the single balloon in 403, Inoue balloon in 89 and a double balloon in six, with no difference between the 2 groups (p=0.6610). RESULTS The prior surgical or balloon valvuloplasty group was older, with higher echo score and higher atrial fibrillation rate and of its 59 patients, 48 had been submitted only to mitral surgical commissurotomy, 8 only to mitral balloon valvuloplasty and 3 to surgical commissurotomy and after submitted to balloon valvuloplasty because of restenosis. In prior surgical or balloon valvuloplasty and mitral balloon valvuloplasty without previous intervention groups pre valvuloplasty there were respectively: echo mitral valve area 0.99+/-0.21 and 0.94+/-0.21 cm2 (p=0.0802) and mitral valve area (Gorlin) 0.94+/-0.18 and 0.91+/-0.21 cm2 (p=0.2518) and post mitral valvuloplasty 1.95+/-0.44 and 2.05+/-0.42 cm2 (p=0.1059). CONCLUSIONS The hemodynamic and angiographic outcome of the prior surgical or balloon valvuloplasty group were similar to the group without previous intervention. The evolution was satisfactory in the prior valvuloplasty subgroup with long-term follow-up.