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1.
Med J Armed Forces India ; 80(1): 102-105, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38261814

RESUMO

Patients with dilated cardiomyopathy who have developed mitral valve regurgitation (MR) with reduced left ventricular ejection fraction and are too sick to undergo any surgical repair or replacement are being treated worldwide through catheter-based percutaneous intervention techniques to treat MR like MitraClip system®. There are very few case reports especially from India on anesthetic management during MitraClip device implantation and its specific considerations. We present a case of a 48-year-old male patient, diagnosed as post-myocarditis dilated cardiomyopathy with poor left ventricular ejection fraction (30-35%) and severe MR who underwent mitral clip implantation with fluoroscopy and transesophageal echocardiography guidance under general anesthesia. We hope that our experience will help and guide future such undertakings in our country.

2.
Indian Heart J ; 76(1): 36-43, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38218314

RESUMO

INTRODUCTION: Transcatheter Aortic Valve Implantation (TAVI) techniques gradually evolved since 2002 and have undergone various refinements. Achieving optimal implantation depth has become crucial for good long term outcome. High implantation decreases the likelihood of conduction disturbances. Conventionally TAVI valve is positioned in a tricusp coplanar (CON) fluoroscopic projection however it does not ensure a optimal implantation. In an attempt to attain higher implantation(3 mm) and decrease rate of permanent pacemaker, cuspal overlap technique (COT) view has been developed. There is scarcity of Indian literature comparing TAVI deployment using coplanar and cuspal overlap techniques. METHODS: We included 111 patients who underwent TAVR with a self-expanding Core Valve Evolut R (Medtronic, Minneapolis, Minnesota), between January 2017 to September 2022 at our centre.Transcatheter Heart Valves (THV) were implanted using the traditional coplanar in 55 patients, while in 56 patients valves were implanted using the COT. RESULTS: Baseline characteristics including electrocardiographic findings were comparable in both groups. In all patients Evolut R or Evolut PRO valves were used. Procedure was done in conscious sedation in 90.9 % of patients in CON and 96.4 % in COT group. Predilatation and postdilatation was used in 38.8 % vs 33.9 % and 27 % vs 32 % in CON and COT groups respectively. 90 day PPI rate was less in COT group (7.3 % CON vs 3.5 % COP). Majority of patients who received permanent pacemaker implantation (PPI) had baseline ECG abnormality (RBBB in 50 %, LBBB in 16 %, Grade 1 AV block 16 %). Mean time of post procedure PPI was 5.6 days in COT group and 7.3 days in CON group. New onset LBBB was also less in COT group (21 % CON vs 12.5 % COT).There were 3.6 % intraprocedural deaths in CON group and 1.8 % in COT group. Depth of deployed valve was 4.8 ± 2.34 mm in COT and 6.6 ± 2.11 mm in CON group. Valve deployment time was more in COT group(10.40 CON vs 14.34 min COT). Average valve recapture rate was 2.58 in COP and 2.11 in CON. Stroke rate was more in COT group(3.6 % CON vs 7.14 % COT). Pericardial effusions were also more in COT group. All cause mortality at 3 months was 10.9 % in CON group and 5.3 % in COT. CONCLUSION: In this study we achieved lower rates of PPI and new onset LBBB using COT technique in Indian patients using self-expandable prostheses. However valve deployment time, stroke rate and pericardial effusion were seen more in COT group. All cause mortality was low in cuspal overlap technique.


Assuntos
Próteses Valvulares Cardíacas , Acidente Vascular Cerebral , Substituição da Valva Aórtica Transcateter , Humanos , Resultado do Tratamento , Eletrocardiografia
3.
Med J Armed Forces India ; 79(Suppl 1): S270-S275, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-38144660

RESUMO

Lead aVR is often considered as a neglected lead or forgotten lead owing to its reciprocal location to the lateral leads. However, it has diagnostic and prognostic importance in cases of acute coronary syndromes. We present a series of four cases of acute coronary syndrome with ST elevation (STE) in aVR and critical stenosis in coronary vessels. Patients with STE in aVR have a poor prognosis with increased morbidity not limited to increased chances of heart failure at presentation, greater hemodynamic instability, and in-hospital acute kidney injury, as well as increased mortality due to large infarction areas. Thus, early revascularization is warranted in such cases.

4.
Cureus ; 15(7): e42169, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37602077

RESUMO

Background Clopidogrel hyporesponsiveness with decreased antiplatelet activity is prevalent in percutaneous coronary intervention (PCI) patients due to reduced function polymorphism in the CYP2C19 enzyme gene which results in poor conversion of this prodrug to an active metabolite. However, pharmacogenetic testing is not part of routine clinical practice in India. Methodology In this retrospective observational study, we observed the prevalence of loss of function (LOF) gene variants of CYP2C19 (*2, *3) in 60 patients undergoing PCI with complex anatomies in a tertiary healthcare hospital in North India. We do not have follow-up data for a few patients. However, the treatment regimen was recorded, and the occurrence of any clinical event was monitored for the remaining 52 patients for six months. Results The mean age of the patients was 61.76 ± 10.14 years. We found that 52% of patients carried these LOF mutations, of which 37% were intermediate metabolizers, while 15% were poor metabolizers of clopidogrel. However, out of 52 patients for whom follow-up data were available, 22 (42.3%) were intermediate metabolizers, while six (11.54%) showed genotypes associated with poor metabolism of clopidogrel. Clopidogrel (75 mg BD) was the primary replacement drug in place of ticagrelor (90 mg BD) during follow-up after four weeks (based on the clinician's discretion). Conclusions No major ischemic event was reported during the follow-up of these 52 patients. The intermediate metabolizers' LOF in one copy of the CYP2C19 gene seems to overcome genetic deficiency with the clopidogrel 75 mg BD regime, which is comparable to maintenance with ticagrelor 90 mg BD. This study can be extrapolated to a larger cohort to observe statistically significant differences among various groups.

5.
Med J Armed Forces India ; 78(4): 377-379, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-36267504
6.
Med J Armed Forces India ; 78(4): 387-393, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-36267505

RESUMO

Backrground: Transcatheter aortic valve replacement (TAVR) has become an accepted modality of treatment in intermediate and high surgical risk patients of symptomatic severe calcific aortic stenosis (AS). We herein report Indian data of 84 intermediate and high-risk patients who underwent TAVR at two Armed Forces cardiac centres. Methods: Most of the patients underwent TAVR in cardiac catheterization lab by percutaneous transfemoral approach, under conscious sedation. Patients were followed up and echocardiographic parameters were assessed after six months of procedure. Results: Total of 84 intermediate and high-risk patients underwent TAVR between Jan 2017 and June 2021. Mean age of population was 71.5 ± 8.4 years; 28.5% of patients had bicuspid aortic valve and Mean STS score was 6.34 ± 2.08. Majority (92.8%) patients underwent the procedure under conscious sedation. Self-expanding valves were used in 72.6% and balloon expandable in 27.4% of patients. Predilatation was done in 64% patients while 13% cases underwent post dilatation. Procedural mortality was 2.3%. Rate of permanent pacemaker implantation was 4.9%. Ischemic stroke occurred in 1.1% of patents. There was no case of severe paravalvular leak. Emergency surgical aortic valve replacement was done in 2.4% patients. Procedural success in this study was 97.6%. All-cause mortality was 9.5% at 6 months. Conclusions: TAVR is an effective treatment modality in intermediate and high-risk Indian patients with severe aortic stenosis. Patients with bicuspid or previous bio prosthetic aortic valves also have a good outcome post TAVR.

7.
Front Cardiovasc Med ; 9: 854554, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35647059

RESUMO

Optical coherence tomography (OCT) is slowly but surely gaining a foothold in the hands of interventional cardiologists. Intraluminal and transmural contents of the coronary arteries are no longer elusive to the cardiologist's probing eye. Although the graduation of an interventionalist in imaging techniques right from naked eye angiographies to ultrasound-based coronary sonographies to the modern light-based OCT has been slow, with the increasing regularity of complex coronary cases in practice, such a transition is inevitable. Although intravascular ultrasound (IVUS) due to its robust clinical data has been the preferred imaging modality in recent years, OCT provides a distinct upgrade over it in many imaging and procedural aspects. Better image resolution, accurate estimation of the calcified lesion, and better evaluation of acute and chronic stent failure are the distinct advantages of OCT over IVUS. Despite the obvious imaging advantages of OCT, its clinical impact remains subdued. However, upcoming newer trials and data have been encouraging for expanding the use of OCT to wider indications in clinical utility. During percutaneous coronary intervention (PCI), OCT provides the detailed information (dissection, tissue prolapse, thrombi, and incomplete stent apposition) required for optimal stent deployment, which is the key to successfully reducing the major adverse cardiovascular event (MACE) and stent-related morbidities. The increasing use of OCT in complex bifurcation stenting involving the left main (LM) is being studied. Also, the traditional pitfalls of OCT, such as additional contrast load for image acquisition and stenting involving the ostial and proximal LM, have also been overcome recently. In this review, we discuss the interpretation of OCT images and its clinical impact on the outcome of procedures along with current barriers to its use and newer paradigms in which OCT is starting to become a promising tool for the interventionalist and what can be expected for the immediate future in the imaging world.

8.
Indian Heart J ; 74(3): 201-205, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35427629

RESUMO

OBJECTIVE: RADPAD is a lead-free sterile drape that reduces scattered radiation during fluoroscopic procedures. We aimed to study the effect of using RADPAD on primary operator (PO) and secondary operator (SO) during coronary angiography (CAG) as well as percutaneous coronary intervention (PCI). METHODS: 137 patients undergoing elective CAG and PCIwere randomized in a 1:1 pattern with or without the RADPAD. The ratio of PO received dose in mrem to total Air Kerma (AK) in mGy, Dose Area Product (DAP) in mGycm2 and Cine Adjusted Screening Time (CAST) in minute, at the end of the procedure with or without RADPAD were measured and designated as dose relative to AK, DAP and CAST. The exposure ratios were compared for both cohorts. RESULTS: There was no significant difference in CAST, DAP and AK between the two patient cohorts. PO radiation dose relative to CAST was 0.15 ± 0.18 mrem/min for RADPAD cohort and 0.43 ± 0.31 mrem/min for No RADPAD cohort (p < 0.00001). PO dose relative to DAP was 0.00042 ± 0.00049 mrem/mGycm2 for RADPAD cohort and 0.0011 ± 0.0013 mrem/mGycm2 for No RADPAD cohort (p = 0.000014). PO dose relative to AK was 0.0030 ± 0.0037 mrem/mGy for RADPAD cohort and 0.0071 ± 0.0049 mrem/mGy for No RADPAD cohort (p < 0.00001). All PO doses relative to CAST, DAP and AK were significantly reduced in the RADPAD cohort compared to the No RADPAD cohort. Similar findings were observed for the SO also. CONCLUSION: RADPAD significantly reduces radiation exposure to both PO and SO during CAG and PCI.


Assuntos
Exposição Ocupacional , Intervenção Coronária Percutânea , Proteção Radiológica , Cateterismo Cardíaco/métodos , Angiografia Coronária/efeitos adversos , Angiografia Coronária/métodos , Fluoroscopia/efeitos adversos , Humanos , Exposição Ocupacional/efeitos adversos , Exposição Ocupacional/prevenção & controle , Doses de Radiação , Radiografia Intervencionista/efeitos adversos
9.
J Invasive Cardiol ; 34(2): E149-E150, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-35100558

RESUMO

During an optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) of a calcified left anterior descending artery (LAD), the distal tip of the OCT catheter got stuck, and forceful tugging on the catheter by the operator led to LAD stent deformation proximally across the overlap between the proximal and middle stents. The purpose of these images is to make the readers aware of the very real and serious risk of a stuck OCT catheter, especially while imaging distal coronary arteries and overlapping stents. Increasing the length of the over-the-wire segment and hydrophilic coating of the OCT catheter may also be explored with manufacturers to prevent this complication.


Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Catéteres , Angiografia Coronária/efeitos adversos , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Stents/efeitos adversos , Tomografia de Coerência Óptica/métodos , Resultado do Tratamento , Ultrassonografia de Intervenção/métodos
10.
Lancet Reg Health Southeast Asia ; 3: 100016, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-37384264

RESUMO

Background: Previous literature suggests that thrombosis is more common in lowlanders sojourning at high altitude (HA) compared to near-sea-level. Though the pathophysiology is partly understood, little is known of its epidemiology. To elucidate this, an observational prospective longitudinal study was conducted in healthy soldiers sojourning for months at HA. Methods: A total of 960 healthy male subjects were screened in the plains, of which 750 ascended, to altitudes above 15,000ft (4,472m). Clinical examination, haemogram, coagulogram, markers of inflammation and endothelial dysfunction, were studied at three time points during ascent and descent. The diagnosis of thrombosis was confirmed radiologically in all cases where a thrombotic event was suspected clinically. Subjects developing thrombosis at HA were labelled as Index Cases (ICs) and compared to a nested cohort of the healthy subjects (comparison group,(CG)) matched for altitude of stay. Findings: Twelve and three subjects, developed venous (incidence: 5,926/105 person-years) and arterial (incidence: 1,482/105 person-years) thrombosis at HA, respectively. The ICs had enhanced coagulation (FVIIa: p<0.001; FXa: p<0.001) and decreased levels of natural anticoagulants (thrombomodulin, p=0.016; tissue factor pathway inhibitor [TFPI]: p<0.001) and a trend to dampened fibrinolysis (tissue plasminogen activator tPA; p=0.078) compared to CG. ICs also exhibited statistically significant increase in the levels of endothelial dysfunction and inflammation markers (vascular cell adhesion molecule-1[VCAM-1], intercellular adhesion molecule-1 [ICAM-1], vascular endothelial growth factor receptor 3 [VEGFR-3], P-Selectin, CD40 ligand, soluble C-reactive protein and myeloperoxidase: p<0.001). Interpretation: The incidence of thrombosis in healthy subjects at HA was higher than that reported in literature at near sea-level. This was associated with inflammation, endothelial dysfunction, a prothrombotic state and dampened fibrinolysis. Funding: Research grants from the Armed Forces Medical Research Committee, Office of the Director General of Armed Forces Medical Services (DGAFMS) & Defence Research and Development Organization (DRDO), Ministry of Defence, India.

11.
Med J Armed Forces India ; 77(4): 403-407, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34594067

RESUMO

BACKGROUND: Soldiers native to lowlands, while sojourning at high altitude (HA), are referred to tertiary care centers with electrocardiographic (ECG) abnormalities. Exposure to HA may precipitate myocardial ischemia in subjects with underlying coronary artery disease (CAD). Conversely, it may produce physiological ECG changes mimicking those of CAD, causing a diagnostic dilemma. This study sought to correlate the presence of CAD on coronary angiography (CAG) with a putative diagnosis of CAD based on clinical findings and ECG. METHODS: A prospective study was conducted on patient's from HA areas, referred for evaluation for CAD to a single center at near-sea-level. Thirty-five minimally symptomatic/asymptomatic soldiers with ECG changes suggestive of CAD, underwent CAG. Correlation was sought between ECG and CAG evidence of CAD. RESULTS: The association of CAD on CAG with clinical and ECG diagnosis of CAD was not significant, 4 of the 35 soldiers (11.4%) showing CAG evidence of CAD (chi square 3.849, p = 0.697). The association between symptoms and coronary artery lesions was, also, not significant, only four of twenty-three (17.4%) minimally symptomatic subjects having CAD on CAG. CONCLUSION: Insignificant numbers of previously healthy persons, who present with minimal symptoms and ECG changes suggestive of CAD while sojourning at HA, have coronary artery involvement on CAG. Those with incidental ECG changes, without symptomatology, do not have CAD on CAG.

12.
Med J Armed Forces India ; 77(4): 413-418, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34594069

RESUMO

BACKGROUND: At our tertiary care cardiology center, we are receiving soldiers who sustained acute ST-Elevation Myocardial Infarction (STEMI) during the strenuous Battle Field Efficiency Test (BPET) and other such activities. METHODS: This was a single-center observational study to assimilate and analyze the precipitating causes, risk factors, symptoms, and the efficacy of the management protocols in soldiers sustaining STEMI during the BPET or other forms of strenuous military training. RESULTS: All 25 soldiers with documented STEMI following strenuous military training presented with chest pain as the primary symptom. 88% had symptoms either during or within 1st hour of the strenuous activity. 76% underwent thrombolysis with an angiographic success rate of 95%. Primary PCI was possible in only 3/25 (12%) of the cases, of which 2 (66%) did not require stenting after thrombus aspiration; 88% of soldiers reported "training for the event" for less than four times/week. CONCLUSION: STEMI precipitated by strenuous unaccustomed military training have exclusively single vessel affection with an excellent response to thrombolysis and thrombus aspiration. Thus, the timely institution of pharmacological or mechanical revascularization therapy has dramatic results in the preservation of ventricular function. The lack of training for the strenuous event provides strong evidence for comprehensive, graded, physical training prior to strenuous military activities to prevent acute coronary syndromes.

13.
Med J Armed Forces India ; 77: S235-S236, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34334885
14.
Med J Armed Forces India ; 77: S264-S270, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34334892

RESUMO

BACKGROUND: On 16 Jan 2021, India launched its immunization program against COVID-19. Among the first recipients were 1.59 million Health Care Workers (HCWs) and Frontline Workers (FLWs) of the Indian Armed Forces, who were administered COVISHIELD (Astra Zeneca). We present an interim analysis of vaccine effectiveness (VE) estimates till 30 May 2021. METHODS: The VIN-WIN cohort study was carried out on anonymized data of HCWs and FLWs of Indian Armed Forces. The existing surveillance system, enhanced for COVID-19 monitoring, was sourced for data. The cohort transitioned from Unvaccinated (UV) to Partially Vaccinated (PV) to Fully Vaccinated (FV), serving as its own internal comparison. Outcomes studied in the three groups were breakthrough infections and COVID related deaths. Incidence Rate Ratio (IRR) was used to compare outcomes among the three groups to estimate VE. RESULTS: Data of 1,595,630 individuals (mean age 27.6 years; 99% male) over 135 days was analysed. Till 30 May 21, 95.4% and 82.2% were partially and fully vaccinated. The UV, PV and FV compartments comprised 106.6, 46.7 and 58.7 million person-days respectively. The number of breakthrough cases in the UV, PV and FV groups were 10061, 1159 and 2512; while the deaths were 37, 16 and 7 respectively. Corrected VE was 91.8-94.9% against infections. CONCLUSION: Interim results of the VIN-WIN cohort study of 1.59 million HCWs and FLWs of Indian Armed Forces showed a ∼93% reduction in COVID-19 breakthrough infections with COVISHIELD vaccination.

15.
Front Cardiovasc Med ; 8: 625873, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33634171

RESUMO

Objectives: In this study, we intend to analyze the feasibility and efficacy of very low frame rate fluoroscopy (VLFF) protocol using a combination of 3.8 and 7.5 fps while performing Percutaneous Coronary Intervention (PCI). Methods: A retrospective cohort including 193 patients undergoing PCI under the VLFF protocol (Post-VLFF group) was compared with a retrospective cohort of 133 patients, who underwent PCI prior to implementation of VLFF protocol (Pre-VLFF group). In the Pre-VLFF group, all PCIs were performed using fluoroscopy frame rate of 15 fps. In the Post-VLFF group, 3.8 fps was used to guide catheter engagement, coronary lesion wiring, pre-and post-dilation, and 7.5 fps was used for lesion assessment and stent placement. Increasing use of fluoroscopic storage in place of cineangiography was also encouraged. Cine acquisition in both groups was performed at 15 fps. Primary endpoint was radiation exposure measured by Air Kerma. Secondary endpoints were procedure related outcomes and patient related outcomes (Major Adverse Cardiac Events including all-cause mortality, Target Lesion Failure, Myocardial Infarction, and Stroke). RESULTS: Post-VLFF group showed 74.7% reduction in Air Kerma as compared to Pre-VLFF group (433 ± 27 mGy vs. 1,714 ± 140 mGy; p < 0.0001), with no increase in the fluoroscopy time (15.38 ± 0.98 min Post-VLFF vs. 17.06 ± 1.29 min Pre-VLFF; p = 0.529) and contrast volume (116.5 ± 4.9 ml Post-VLFF vs. 116.7 ± 6 ml Pre-VLFF; p = 0.700). Both groups had comparable procedural success and complications rates as well as incidence of MACE. Conclusions: The very low frame rate fluoroscopy protocol is a feasible, effective, and safe method to significantly reduce the radiation exposure during PCI without any compromise on procedural and patient outcomes.

16.
Indian Heart J ; 72(5): 376-382, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33189197

RESUMO

BACKGROUND: In this study we report our experience in implanting MICRA TPS (transcatheter pacing system) at various RV sites; observing its safety, and impact on paced QRS in Indian population. MATERIAL & METHODS: 35 patients with MICRA TPS deployed from March 2017 to December 2019 at Army Hospital Research and Referral, New Delhi, at RVOT, apical septum and mid septum of RV were enrolled in the study. These patents were followed up and impact of implantation site, procedure related complications, change in pacing parameters, left ventricular ejection fraction and duration of paced QRS were monitored. RESULTS: Sick sinus syndrome was the commonest indication of pacing in this study (51.5%), followed by high degree AV block (34.2%). Mean follow up of 1.4 years showed no change in left ventricular ejection fraction, electrical parameters or change in pacing thresholds after implantation. Mean pQRS was broadest (166.60 ms) in apically implanted MICRA TPS and narrowest in mid septum group 139.33 ms. Among 35 cases, in our study one patient developed pericardial effusion, and other had intermittent diaphragmatic pacing. CONCLUSION: Among these three implantation sites mid septum deployment is associated with narrowest paced QRS in Indian population.


Assuntos
Bloqueio Atrioventricular/terapia , Eletrocardiografia/métodos , Marca-Passo Artificial , Volume Sistólico/fisiologia , Função Ventricular Esquerda/fisiologia , Idoso , Idoso de 80 Anos ou mais , Bloqueio Atrioventricular/fisiopatologia , Desenho de Equipamento , Feminino , Seguimentos , Humanos , Masculino , Estudos Prospectivos , Resultado do Tratamento
18.
JACC Case Rep ; 2(11): 1692-1697, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34317036

RESUMO

Coronary artery aneurysm (CAA) after drug-eluting stent implantation is rare, with a reported incidence of 0.3% to 6.0%. Most of these aneurysms are asymptomatic. Hemoptysis as a presentation of CAA is very rare. The patient in our case had CAA after zotarolimus-eluting stent implantation and presented with hemoptysis resulting from a leaking coronary-bronchial fistula. (Level of Difficulty: Intermediate.).

19.
Indian J Med Res ; 142(2): 165-74, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-26354213

RESUMO

BACKGROUND & OBJECTIVES: Acute myocardial infarction (AMI) is characterized by irreparable and irreversible loss of cardiac myocytes. Despite major advances in the management of AMI, a large number of patients are left with reduced left ventricular ejection fraction (LVEF), which is a major determinant of short and long term morbidity and mortality. A review of 33 randomized control trials has shown varying improvement in left ventricular (LV) function in patients receiving stem cells compared to standard medical therapy. Most trials had small sample size and were underpowered. This phase III prospective, open labelled, randomized multicenteric trial was undertaken to evaluate the efficacy in improving the LVEF over a period of six months, after injecting a predefined dose of 5-10 × 10 [8] autologous mononuclear cells (MNC) by intra-coronary route, in patients, one to three weeks post ST elevation AMI, in addition to the standard medical therapy. METHODS: In this phase III prospective, multicentric trial 250 patients with AMI were included and randomized into stem cell therapy (SCT) and non SCT groups. All patients were followed up for six months. Patients with AMI having left ventricular ejection fraction (LVEF) of 20-50 per cent were included and were randomized to receive intracoronary stem cell infusion after successfully completing percutaneous coronary intervention (PCI). RESULTS: On intention-to-treat analysis the infusion of MNCs had no positive impact on LVEF improvement of ≥ 5 per cent. The improvement in LVEF after six months was 5.17 ± 8.90 per cent in non SCT group and 4.82 ± 10.32 per cent in SCT group. The adverse effects were comparable in both the groups. On post hoc analysis it was noted that the cell dose had a positive impact when infused in the dose of ≥ 5 X 10 [8] (n=71). This benefit was noted upto three weeks post AMI. There were 38 trial deviates in the SCT group which was a limitation of the study. INTERPRETATION & CONCLUSIONS: Infusion of stem cells was found to have no benefit in ST elevation AMI. However, the procedure was safe. A possible benefit was seen when the predefined cell dose was administered which was noted upto three weeks post AMI, but this was not significant and needs confirmation by larger trials.


Assuntos
Infarto do Miocárdio/terapia , Transplante de Células-Tronco , Células-Tronco/citologia , Disfunção Ventricular Esquerda/terapia , Idoso , Medula Óssea , Ecocardiografia , Feminino , Humanos , Índia , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/patologia , Resultado do Tratamento , Disfunção Ventricular Esquerda/patologia
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