Small-incision cholecystectomy (through a cylinder retractor) under local anaesthesia and sedation: a prospective observational study of five hundred consecutive cases.

BACKGROUND: Transcylindrical cholecystectomy (TC) can be performed under local anaesthesia and sedation (LAS) in ambulatory surgery (AS). The aim of this study was to assess the feasibility and results of TC under LAS. METHODS: TC under LAS was proposed to 583 consecutive patients with cholelithiasis in an AS unit. For the TC procedure, a cylindrical retractor with a transparent plunger was inserted into the hepatocystic triangle, and cholecystectomy was performed through the retractor with reusable open instruments. Pre-, intra-, and post-operative variables were prospectively registered, including complications, reasons for conversion to general anaesthesia (GA), non-programmed admissions, readmissions, pain assessments, and satisfaction with the procedure. RESULTS: Five hundred patients were eligible for LAS, with GA being required in 128 (25.6%) of them. AS was programmed for 447 patients. The rates of non-programmed admissions, readmissions, and conversion to laparotomy were 8.7% (39), 0.8% (4), and 2.6% (13), respectively. There was no main bile duct injury. At 24 h, physical status was good or excellent in 80.4% of the patients. A history of acute cholecystitis, male sex, a body mass index (BMI) ≥ 39.5 kg/m2, and non-suspected acute cholecystitis were found to be independent variables associated with conversion to GA. CONCLUSIONS: TC under LAS is a safe procedure in AS and is feasible in 74% of cholelithiasis patients. Male sex, BMI, gallbladder wall thickness, and a history of acute cholecystitis are factors that increase the probability of conversion to GA. This prospective study was approved by the ethics committee of Badajoz for patient protection for biomedical research and has been retrospectively registered under the research registry UIN: researchregistry3979.

Efficacy of stem cell in improvement of left ventricular function in acute myocardial infarction--MI3 Trial.

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.

Assessment of left ventricular systolic function by velocity vector imaging.

OBJECTIVES: To study the usefulness of a novel echocardiographic technique, velocity vector imaging (VVI) in the measurement of left ventricular ejection fraction (LVEF). BACKGROUND: Ejection fraction measured by echocardiography forms the cornerstone in the assessment of LV systolic function. Errors in measurement of EF by routine two-dimensional echocardiography (2D ECHO) limit its utility. The VVI is a new technology which uses speckle tracking and other algorithms to track the endocardial border. This may help in more accurate assessment of EF. METHODS: Global and regional LVEF was measured in 49 patients using VVI, 2D ECHO and radionuclide-gated single photon emission computed tomography (SPECT). Results were categorised as normal, mild, moderate, or severe LV systolic dysfunction based on American Society of ECHO classification. The results were analysed by appropriate statistical tests for correlations. RESULTS: The mean EF was 35 ± 12.08% by VVI, 54.2 ± 19.51% by SPECT (P< 0.001 vs VVI) and 50.3 ± 8.92% by 2D ECHO (P < 0.001 vs VVI). There was weak linear positive correlation between EF measured by VVI and the other modalities (Pearson's correlation coefficient 0.577 for SPECT and 0.573 for 2D; P=0.01). The VVI systematically underestimated the EF compared to SPECT. Greater number of patients had moderate or severe LV systolic dysfunction by VVI (37; 74.5%) than by SPECT (17; 34.7%; P=0.037). We derived a correction factor to calculate SPECT EF from VVI EF as follows: EF (SPECT) = EF (VVI) × 0.9 + 21 or approximately VVI (EF) + 20. CONCLUSION: Measurement of EF by VVI is feasible. The VVI underestimated the EF when compared to nuclear-gated SPECT in this study. The accuracy of this technology and the need for a correction factor needs to be assessed in future studies.

Electrical remodelling of the left and right atria due to rheumatic mitral stenosis.

AIMS: To characterize the atrial remodelling in mitral stenosis (MS). METHODS AND RESULTS: Twenty-four patients with severe MS undergoing commissurotomy and 24 controls were studied. Electrophysiological evaluation was performed in 12 patients in each group by positioning multi-electrode catheters in both atria to determine the following: effective refractory period (ERP) at 10 sites at 600 and 450 ms; conduction time; conduction delay at the crista terminalis (CT); and vulnerability for atrial fibrillation (AF). P-wave duration (PWD) was determined on the surface ECG. In the remaining 12 patients in each group, electroanatomic maps of both atria were created to determine conduction velocity and identify regions of low voltage and electrical silence. Patients with MS had larger left atria (LA) (P < 0.0001); prolonged PWD (P = 0.0007); prolonged ERP in both LA (P < 0.0001) and right atria (RA) (P < 0.0001); reduced conduction velocity in the LA (P = 0.009) and RA (P < 0.0001); greater number (P < 0.0001) and duration (P< 0.0001) of bipoles along the CT with delayed conduction; lower atrial voltage in the LA (P < 0.0001) and RA (P < 0.0001); and more frequent electrical scar (P = 0.001) compared with controls. Five of twelve with MS and none of the controls developed AF with extra-stimulus (P = 0.02). CONCLUSION: Atrial remodelling in MS is characterized by LA enlargement, loss of myocardium, and scarring associated with widespread and site-specific conduction abnormalities and no change or an increase in ERP. These abnormalities were associated with a heightened inducibility of AF.

Echocardiographic evaluation of ventricular dyssynchrony in patients with left bundle branch block.

OBJECTIVE: To test whether patients with left bundle branch block (LBBB) and low ejection fraction (EF) have greater dyssynchrony than those with LBBB and normal LV systolic function. METHODS: From a group of patients with LBBB, 38 patients with low EF (<50%) and 31 with normal LV systolic function (EF > or = 50%), all comparable in age and sex underwent standard Doppler echo, ECG and tissue Doppler imaging (TDI). The precontraction time (PCTm) was calculated as an index of myocardial systolic activation in 5 different basal myocardial segments (LV anterior, inferior, septal, lateral walls and RV lateral wall). Intraventricular systolic dyssynchrony was analyzed by difference of PCTm in different LV myocardial segments. Interventricular activation delay was calculated by the difference of PCTm between the most delayed LV segment and RV lateral wall. RESULTS: Patients with low LV EF showed increased QRS duration, intraventricular delay (p = 0.03) and interventricular dyssynchrony (p = 0.006). Patients with normal EF also had evidence of some dyssynchrony. The LV basal lateral segment was significantly delayed when compared to all other segments in the low EF group. The PCTm was greater for those with low EF when compared to the normal EF group. CONCLUSIONS: All patients with LBBB on baseline ECG had some degree of cardiac dyssynchrony; those with lower EF had more dyssynchrony. TDI is an effective non-invasive technique for assessing the severity of regional delay in activation of ventricular walls in patients with LBBB.

Nonresponders to clopidogrel therapy among Indian patients undergoing elective/adhoc angioplasty.

BACKGROUND: Clopidogrel has become the standard antiplatelet drug along with aspirin in patients undergoing coronary angioplasty; however, data regarding the nonresponse rate to clopidogrel therapy in Indian patients are limited. METHODS AND RESULTS: Platelet aggregation was measured at baseline and 2 and 24 hours post administration of bolus dose of 300 mg clopidogrel, followed by 75 mg once daily in patients undergoing elective or adhoc coronary angioplasty. Baseline platelet aggregation with 2.5 and 10 micromol/L ADP was 27.91 +/- 20.9% and 53.45 +/- 22.44%. Platelet aggregation at 2 hours and 24 hours with 2.5 micromol/L of ADP was 19.65 +/- 16.9% and 10.44 +/- 11.9%. The corresponding values with 10 micromol of ADP were 48.81 +/- 25.3% and 27.04 +/- 22.4%. Platelet aggregation was maximally inhibited at 24 hours with both 2.5 and 10 micromol/L of ADP. Marked interpatient variability in platelet aggregation in response to clopidogrel administration was observed and varied from -43 to 65%, -32 to 85% with 2.5 micromol/L at 2 hours and 24 hours and -65 to 53%, -35 to 97% with 10 micromol/L ADP at 2 hours and 24 hours. Nonresponse rate 2 hours after clopidogrel administration was 47.7%, and decreased to 29.2% at 24 hours post drug administration. CONCLUSION: Clopidogrel nonresponse is prevalent among Indian patients, and there is wide interpatient variability in platelet inhibition among individual patients. However, the clinical implications of these findings need to be substantiated in larger studies with clinical end points.

Pseudoaneurysm of the left atrium following infective endocarditis.

Transthoracic echocardiogram of a 3-year-old child showed a hypoechoic cavity in the posterior wall of the left atrium communicating with the left ventricle through an orifice in the mitral annulus, suggestive of pseudoaneurysm (Ps), probably the result of infective endocarditis. Three-dimensional echocardiography was helpful to confirm the diagnosis and assess the anatomical relationship of the Ps.

[Intraoperative neuromonitoring in thyroid surgery]. / Neuromonitorización intraoperatoria en cirugía tiroidea.

BACKGROUND: Intraoperative neuromonitoring of the recurrent laryngeal nerve in thyroid surgery facilitates the identification of anatomical structures in cervical endocrine surgery reducing the frequency of vocal cord paralysis. OBJECTIVE: To study the normal electrophysiological values of the vague and recurrent laryngeal nerves before and after thyroid surgery. To compare rates of injury of recurrent nerve before and after the introduction of the intraoperative neuromonitoring in thyroid surgery. MATERIAL AND METHODS: An observational, descriptive and prospective study in which a total of 490 patients were included. Between 2003-2010, surgery was performed on 411 patients (703 nerves at risk) with systematic identification of recurrent laryngeal nerves. Between 2010-2011 neuromonitorization was also systematically performed on 79 patients. RESULTS: Before the introduction of intraoperative neuromonitoring of 704 nerves at risk, there were 14 recurrent laryngeal nerve injuries. Since 2010, after the introduction of the intraoperative neuromonitoring in thyroid surgery, there has been no nerve injury in 135 nerves at risk. CONCLUSIONS: We consider the systematic identification of the recurrent laryngeal nerve is the 'gold standard' in thyroid surgery and the intraoperative neuromonitoring of nerves can never replace surgery but can complement it.

[Use of absorbable fibrin sealant patch to strengthen the gastrointestinal anastomosis performed on patients with peritoneal carcinomatosis treated with intention to cure by debulking surgery and intraoperative hyperthermic intraperitoneal chemotherapy]. / Aplicación de sellante tisular como refuerzo de las anastomosis digestivas realizadas en pacientes con carcinomatosis peritoneal tratados con intención curativa mediante procedimiento quirúrgico de citorreducción y quimioterapia intraperitoneal intraoperatoria hipertérmica.

BACKGROUND: Peritoneal disseminated disease, regardless of its origin, should currently be considered a locoregional disease stage, and thus a candidate for an intention to treat therapeutic option with debulking surgery and hyperthermic intraperitoneal chemotherapy. OBJECTIVE: To determine whether or not the collagen sponge with fibrinogen 5.5mg and thrombin 2IU, applied as a tissue sealant and gastrointestinal reinforcement sutures, contributes to the reduction of anastomotic leak. MATERIAL AND METHODS: Quasi-experimental, comparative, prospective, case/control study conducted on patients with peritoneal carcinomatosis of colorectal origin, operated on in our Peritoneal Cancer Surgery Unit from 2011 to April 2014. The study included 73 patients, 43 (59%) men and 30 (41%) women with peritoneal carcinomatosis of colorectal origin, candidates for debulking surgery and hyperthermic intraperitoneal chemotherapy. Gastrointestinal anastomoses were performed on 49 (67%) patients. These patients were randomised into 2 groups: A control (27) and B hypothesis (22) reinforced with sponge suture. RESULTS: The total number of anastomoses performed was 49 (mean: 1.9), with 27 in the control group A (mean: 1.88) and 22 in B (mean: 2.16). The debulkings achieved were: complete debulking 0.38 (77.5%), complete debulking 1: 7 (14.8%), and 4 (8.1%) did not undergo hyperthermic intraperitoneal chemotherapy due to complete debulking>2. Intestinal fistula: 3 cases (6.1%) in A group vs 0 in B. CONCLUSIONS: In our series, the use of a fibrinogen and thrombin sponge has contributed to a significant reduction in the risk of gastrointestinal fistulas in high risk oncology patients.

Evaluation of a simplified transseptal mitral valvuloplasty technique using over-the-wire single balloons and complementary femoral and jugular venous approaches in 1,407 consecutive patients.

The over-the-wire double balloon technique (DBT) of balloon mitral valvuloplasty (BMV) has been decreasingly used in recent years because of its relative complexity and potential for left ventricular perforation. We attempted to make over-the-wire BMV simpler and safer by developing: (a) a single balloon technique (SBT) using a rapidly inflating, over-the-wire, cylindrical balloon having abrupt distal taper and short blunt tip to prevent left ventricular perforation, and (b) an alternative jugular approach to reduce technical difficulty in patients with cardiac anatomic distortion. SBT-BMV was evaluated over seven years in 1,407 consecutive patients (femoral approach: 1,277 patients, jugular approach: 130 patients), and compared with 954 patients who underwent DBT-BMV earlier at the same center. Results of SBT-BMV were comparable to those of DBT-BMV: optimal outcomes (91.0% versus 87.8%), fluoroscopy time (12.4 +/- 6.8 minutes versus 17.6 +/- 7.2 minutes), significant right heart oxygen step-up (4.8% versus 10.7%), and major complication rates (3.7% versus 5.6%) were significantly better with SBT-BMV; whereas mean post-BMV mitral valve area (1.92 +/- 0.31 cm2 versus 2.03 +/- 0.42 cm2), and post-BMV hemodynamic parameters were inferior with SBT-BMV. Balloon-related left ventricular perforation did not occur in SBT-BMV. Fluoroscopy time in jugular approach SBT-BMV (9.0 +/- 4.2 minutes) was significantly lower than in the femoral approach SBT-BMV (12.4 +/- 6.8 minutes) despite cardiac anatomic distortion. SBT-BMV reduced procedural costs considerably. SBT-BMV was effective, safe, technically simple and economical; it was comparable to, and overcame several limitations of DBT-BMV.

Utility of N-terminal pro-brain natriuretic peptide for the diagnosis of heart failure.

BACKGROUND: The goal of this study was to evaluate the utility of plasma N-terminal pro-brain natriuretic peptide for the diagnosis of heart failure in patients presenting with shortness of breath. METHODS AND RESULTS: We measured plasma levels of N-terminal pro-brain natriuretic peptide in 119 patients presenting with shortness of breath. The patients were divided into two groups based on the Framingham criteria and echocardiographic results--those with heart failure and those not in heart failure. Plasma levels of N-terminal pro-brain natriuretic peptide were compared in the two groups. The mean N-terminal pro-brain natriuretic peptide concentration in patients with heart failure (n=73) was higher than that in those not in heart failure (389+/-148 fmol/ml v. 142+/-54 fmol/ml, p<0.001). N-terminal pro-brain natriuretic peptide values increased significantly as the functional severity of heart failure increased (p<0.001). The mean N-terminal pro-brain natriuretic peptide levels were 261+/-34 fmol/ml for patients in New York Heart Association functional class I, 300+/-161 fmol/ml for patients in New York Heart Association functional class II, 427+/-103 fmol/ml for patients in New York Heart Association functional class III and 528+/-170 fmol/ml for patients in New York Heart Association functional class IV. Using a cut-off value of 200 fmol/ml, the sensitivity of N-terminal pro-brain natriuretic peptide was 97%, specificity was 89% and accuracy for differentiating heart failure from other causes of shortness of breath was 93%. CONCLUSIONS: Our results suggest that N-terminal pro-brain natriuretic peptide can be reliably used for the diagnosis of heart failure in an outpatient setting, and this will improve the ability of clinicians to differentiate patients with shortness of breath due to heart failure from those with other causes of shortness of breath.

Association between gender, process of care measures, and outcomes in ACS in India: results from the detection and management of coronary heart disease (DEMAT) registry.

BACKGROUND: Studies from high-income countries have shown that women receive less aggressive diagnostics and treatment than men in acute coronary syndromes (ACS), though their short-term mortality does not appear to differ from men. Data on gender differences in ACS presentation, management, and outcomes are sparse in India. METHODS AND RESULTS: The Detection and Management of Coronary Heart Disease (DEMAT) Registry collected data from 1,565 suspected ACS patients (334 women; 1,231 men) from ten tertiary care centers throughout India between 2007-2008. We evaluated gender differences in presentation, in-hospital and discharge management, and 30-day death and major adverse cardiovascular event (MACE; death, re-hospitalization, and cardiac arrest) rates. Women were less likely to present with STEMI than men (38% vs. 55%, p<0.001). Overall inpatient diagnostics and treatment patterns were similar between men and women after adjustment for potential confounders. Optimal discharge management with aspirin, clopidogrel, beta-blockers, and statin therapy was lower for women than men, (58% vs. 65%, p = 0.03), but these differences were attenuated after adjustment (OR = 0.86 (0.62, 1.19)). Neither the outcome of 30-day mortality (OR = 1.40 (0.62, 3.16)) nor MACE (OR = 1.00 (0.67, 1.48)) differed significantly between men and women after adjustment. CONCLUSIONS: ACS in-hospital management, discharge management, and 30-day outcomes did not significantly differ between genders in the DEMAT registry, though consistently higher treatment rates and lower event rates in men compared to women were seen. These findings underscore the importance of further investigation of gender differences in cardiovascular care in India.