Three-year outcomes of surgical valve replacement with Dafodil™ pericardial bioprosthesis: Dafodil™-1 trial.

Background: The Dafodil™-1 trial was designed to evaluate the clinical safety and performance of Dafodil™ pericardial bioprosthesis for replacing diseased native or prosthetic aortic or mitral valves in patients with advanced valvular heart disease (VHD). Methods: The Dafodil™-1 trial was a prospective, multicenter, first-in-human clinical trial. Patients were enrolled if they had advanced VHD requiring aortic valve replacement (AVR) or mitral valve replacement (MVR) with or without concomitant valve surgery and having surgical risk scores <4%. Major adverse cardiac events (MACE), including all-cause death, myocardial infarction (MI), and stroke; and hemodynamics were analyzed. Results: A total of 136 patients (aortic: 67 and mitral: 69) were enrolled in the trial (with mean age-AVR group: 60.2 ± 8.3 years and MVR group: 49.7 ± 14.4 years). A total of 134 patients (aortic: 66 and mitral: 68) completed the 3-year follow-up (total 300 per 100 patient-years of follow-up). The AVR group demonstrated a significant reduction in the mean pressure gradients from 51.2 ± 24.1 mmHg at baseline to 11.1 ± 6.0 mmHg at the 3-year follow-up (p < 0.0001). The mean effective orifice area (EOA) improved from baseline (0.9 ± 0.6 cm2) to 3-year follow-up (1.8 ± 0.4 cm2) (p < 0.0001). In the MVR group, the mean indexed EOA (iEOA) increased significantly from baseline (0.7 ± 0.4 cm2/m2) to 3-year follow-up (1.1 ± 0.4 cm2/m2) (p < 0.001). There was significant improvement in New York Heart Association functional class and mean SF-12 scores in both groups. At 3-year follow-up, the MACE incidence was 2.3% per 100 patient-years (1.3% strokes per 100 patient-years and 1.3% deaths per 100 patient-years) for AVR group and 4.7% per 100 patient-years (0.6% strokes per 100 patient-years and 4.0% deaths per 100 patient-years) for MVR group. No cases of MI, structural valve deterioration and prosthetic valve endocarditis were reported. The AVR and MVR groups achieved 89.6% and 79.7% MACE-free survival, respectively at 3-year follow-up. Conclusions: The Dafodil™-1 trial demonstrated satisfactory outcomes of clinical safety, hemodynamic performance, and quality-of-life metrics. Additionally, no incidence of structural valve deterioration and very low rates of valve thrombosis during the 3-year follow-up period of Dafodil™-1 first-in-human trial indicated acceptable valve durability up to three years and similar outcomes are warranted for longer follow-ups as a primary goal. Clinical Trial Registration Number: https://www.ctri.nic.in/Clinicaltrials/showallp.php?mid1=18377&EncHid=&userName=CTRI/2017/07/009008, CTRI/2017/07/009008.

IACTS guidelines: practice of cardiovascular and thoracic surgery in the COVID-19 era.

Patients undergoing cardiovascular and thoracic procedures are at an accentuated risk of higher morbidity and mortality, which are a consequence of the proliferative nature of the severe acute respiratory syndrome-corona virus 2 (SARS-CoV-2) on the lung vasculature, which in turn reflects as a cascading effect on the interdependent physiology of the cardiovascular and pulmonary organ systems. These are secondary to systemic inflammatory response syndrome and immunosuppressive responses to surgery and mechanical ventilation. Thus, the need to establish guidelines for the practice of cardiothoracic surgery which is safe for both the patient and the healthcare team presents as a priority, which is the mainstay of this article.

Clinical outcomes and hemodynamic performance of Dafodil™ aortic and mitral pericardial bioprosthesis: 1-year results from Dafodil-1 first-in-human trial.

BACKGROUND: Bioprosthesis has been increasingly implanted for the treatment of transvalvular disease across the world. A new Dafodil™ pericardial bioprosthesis (Meril Life Sciences Pvt. Ltd., India) recently approved by Conformité Européenne (CE) is a tri-leaflet, stented, bovine valve. The purpose of Dafodil-1 first-in-human trial was to evaluate clinical safety and performance (including hemodynamic parameters) of the Dafodil pericardial bioprosthesis in patients who underwent aortic or mitral valve replacement. METHODS: This prospective, multicenter clinical trial enrolled 60 patients (Aortic: 30 patients; Mitral: 30 patients) from seven sites across India. Safety endpoints were early (≤30 days) and late (> 30 days) mortality and valve-related morbidity. The performance endpoints were hemodynamic performance, improvement in NYHA functional class, and change in the quality of life using SF-12v1 health survey. RESULTS: From July 2017 to July 2018, 60 patients underwent implantation of the Dafodil pericardial bioprosthesis. Post-operatively, NYHA functional class significantly improved in all the patients (Aortic: 90% NYHA class-I and 10% NYHA class-II; Mitral: 96.55% NYHA class-I and 3.45% NYHA class-II; P < 0.001). There was no death in aortic valve replacement patients till 12-month. In mitral valve replacement patients, early mortalities occurred in three patients, and late mortality occurred in one patient; none of these were valve-related. Freedom from all-cause mortality reported was 93.33% at 12-month. Mean aortic pressure gradient decreased from 52.71 ± 24.47 mmHg [with 0.89 ± 0.70 cm2 effective orifice area (EOA)] pre-operatively to 14.49 ± 6.58 mmHg (EOA: 1.85 ± 0.27 cm2) at 12-month. Overall, the mitral mean pressure gradient and EOA were 4.41 ± 1.69 mmHg and 2.67 ± 0.48 cm2, respectively, at 12-month. Significant improvement (P < 0.05) in the patients' quality of life was reported at all follow-ups. CONCLUSIONS: The clinical safety and performance of the Dafodil pericardial bioprosthesis were favourable at 12-month. Moreover, a study with a larger patient population and longer follow-up is warranted to further assess the device. TRIAL REGISTRATION: Dafodil-1 trial has been prospectively registered on 10/07/2017 under Clinical Trial Registry-India (http://www.ctri.nic.in). (Registration number: CTRI/2017/07/009008).

Predictors of operative mortality following primary coronary artery bypass surgery.

BACKGROUND: Although quality assessment of coronary artery patients can be done by 30 days risk-adjusted operative mortality, it is still insufficient to study the outcome after primary coronary artery bypass graft surgery (CABG). In our study, we attempted to determine the factors, which can help predict operative mortality before and after CABG. METHODS: The study population consisted of 1000 prospective patients who underwent primary isolated CABG. Assessment was done by dividing the patients into two groups, i.e. non-survivors ( n= 12) and survivors ( n= 988). Data were analyzed using both univariate and multivariate models. RESULTS: On univariate analysis, recent acute myocardial infarction, intra-aortic balloon counterpulsation (IABC), left ventricular ejection fraction (LVEF) <25%, ventilator-associated pneumonia (VAP), tracheostomy, re-exploration, ventricular arrhythmias, low cardiac output (CO), multiple blood transfusions, post-operative renal dysfunction and longer intensive care unit and hospital stay were found as risk factors for mortality. Multivariate analysis showed that LVEF <25%,VAP, ventricular arrhythmias and low CO independently predicted mortality. Prior knowledge of these risk factors can help not only in predicting the outcome and the risks but also helps to plan the surgical and post-operative course of the patients to improve the morbidity and mortality. CONCLUSION: Our data suggest that operative mortality can be predicted prior to and after surgery considering factors such as LVEF, use of IABC, onset of ventricular arrhythmias and low CO.

Evolution of Off-Pump Coronary Artery Bypass Grafting over 15 Years: A Single-Institution Experience of 14,030 Cases.

BACKGROUND: : Off-pump coronary artery bypass grafting for multivessel disease is an important alternative to conventional myocardial revascularization using cardiopulmonary bypass. The development of exposure and stabilization techniques has made this surgery simple, safe, and routine. Experience with the technique, its evolution, the learning curve, and the pitfalls is presented. METHODS: : A retrospective analysis was made of 28,216 patients who underwent elective coronary artery bypass grafting over a 15-year period from January 1990 through December 2004. Isolated off-pump coronary artery bypass grafting was performed in 14,030 patients and on-pump coronary artery bypass grafting in 14,186 patients. The overall period was divided into 3 groups of 5 years each: group I (1990-1994), group II (1995-1999), and group III (2000-2004). Initially, off-pump coronary artery bypass grafting was performed selectively in high-risk patients (eg, atheromatous aorta, severe systemic impairment, chronic obstructive pulmonary disease, octogenarian). Recently (2000-2004), multivessel off-pump coronary artery bypass grafting has been performed electively in 96% to 98% of patients undergoing coronary artery bypass grafting. Patients' medical charts were reviewed for age, preoperative risk factors, operative findings, intraoperative conversion rate to cardiopulmonary bypass, postoperative complications, and length of hospital stay. RESULTS: : In the years 1990-1994 (group I), mostly high-risk cases and cases with left anterior descending coronary artery lesions were included for off-pump coronary artery surgery. In the years 1995-1999 (group II), patients with double and triple vessel disease presenting for coronary artery bypass surgery were accepted for off-pump surgery irrespective of preoperative risk factors. However, in the years 2000-2004 (group III), off-pump coronary artery bypass surgery was the first choice of approach for any patient presenting for coronary artery bypass surgery. The mean number of grafts was lower in off-pump cases than in on-pump cases in group I (2.0 ± 0.4 vs. 3.2 ± 0.80) and group II (2.6 ± 0.6 vs. 3.3 ± 0.4), whereas the mean number of grafts was higher in off-pump cases than in on-pump cases in group III (3.5 ± 0.2 vs. 3.4 ± 0.8). In groups I and II, the conversion to cardiopulmonary bypass was 5.2% and 5.9%, respectively. The conversion to cardiopulmonary bypass decreased to 1.7% in group III, which was statistically significant. Perioperative myocardial infarction was 5.2% in group I, 1.7% in group II, and 1.5% in group III. The difference between groups II and III was not statistically significant. Hospital mortality was higher in group I (5.2%) than in group II (1.2%) or III (1.1%). The difference between groups II and III was not statistically significant. Length of intensive care unit stay was 36 ± 8 hours in group I, 28 ± 7 hours in group II, and 20 ± 8 hours in group III. These differences were statistically significant. Length of postoperative hospital stay was 8 ± 2 days in group I, 7 ± 2 days in group II, and 5 ± 2 days in group III These differences were statistically significant. CONCLUSIONS: : As surgeons' experience matures, off-pump coronary artery bypass surgery permits total myocardial revascularization in virtually all patients with multivessel coronary artery disease. Despite a significant learning curve, evolution to routine off-pump coronary artery bypass with good patient outcomes can be achieved with careful patient selection during the "learning curve." The method is safe and reproducible, and patients benefit with shorter intensive care unit and hospital stays.

Three-Dimensional Reconstruction of Ultrafast 16-Slice Computed Tomography Images and CT Angiography Versus Conventional Coronary Angiography at One Year in Multivessel Coronary Artery Bypass Surgery.

BACKGROUND: : The aim of this study was to evaluate and compare the postoperative graft patency assessment by multislice spiral computed tomography (MSCT) scan and conventional coronary angiography (CCA) in coronary artery bypass grafting (CABG) patients 1 year after surgery. METHODS: : Sixty-nine patients who underwent isolated CABG at least 1 year before the study, were subjected to both MSCT angiography with cardiac gating and CCA. The results were evaluated and compared. RESULTS: : There were 209 grafts in 69 patients. All grafts were evaluated by both MSCT angiography and CCA. Seventy-eight grafts were on the anterior wall, 83 on the lateral wall and 48 on the inferior wall of the heart.On MSCT angiography, all left internal mammary arteries were visualized with 3-dimensional reconstruction and found to be patent. Of 209 grafts, 11 grafts (5.26%) were blocked, 6 grafts on the lateral wall and 5 on the inferior wall. All patent grafts were correctly evaluated by MSCT angiography (specificity 100%). However, 2 grafts that were found to be patent on MSCT angiography were blocked on CCA (MSCT sensitivity 81.8%). CONCLUSIONS: : Postoperative evaluation of coronary bypass grafts is possible with very good resolution by MSCT angiography. This method allows evaluation of the bypass grafts and the quality of anastomosis with a noninvasive method that is comparable with CCA.

Concomitant carotid endarterectomy and coronary bypass surgery: outcome of on-pump and off-pump techniques.

BACKGROUND: There continues to be a dilemma regarding the best means of surgical management of significant carotid artery disease in patients requiring coronary artery bypass surgery. A combined approach of coronary artery bypass and carotid endarterectomy has shown good results in patients with concomitant carotid and coronary artery disease. We reviewed our results of coronary artery surgery using conventional cardiopulmonary bypass or off-pump techniques and carotid endarterectomy done as a combined procedure. METHODS: Between January 1996 and June 2002, 358 patients underwent concomitant coronary artery bypass and carotid endarterectomy. There were 140 males (84.3%) and 26 females (15.7%) in group I. Group II consisted of 158 males (82.3%) and 34 females (17.7%). One hundred sixty-six patients (group I) were done off pump whereas in 192 patients (group II), the procedure was done using conventional cardiopulmonary bypass. Carotid endarterectomy was performed before coronary artery bypass surgery in both groups. RESULTS: The average number of grafts were 3.4 +/- 0.8 with average operative time of 4.2 +/- 0.4 hours in group I, and 3.3 +/- 0.8 graft with operative time of 5.3 +/- 1.2 hours in group II (p = 0.239 and p < 0.001, respectively). There were 2 deaths (1.2%) in group I and 3 deaths (1.6%) in group II (p = 0.870). No patient from group I and 1 patient (0.5%) from group II had postoperative stroke (p = 0.941). Mean hospital stay was 9.0 +/- 1.2 days in group I and 11.2 +/- 1.7 days in group II (p < 0.001). At mean follow-up of 2.8 +/- 0.9 years in group I, 2 patients (1.2%) had late death due to cardiac failure and contralateral carotid endarterectomy was done in 2 patients (1.2%). Group II had mean follow-up of 2.4 +/- 0.6 years, during which 4 patients (2.1%) had late death and contralateral carotid endarterectomy was done in 3 patients (1.6%). Late stroke was seen in 1 patient (0.6%) from group I and 2 patients (1.0%) from group II. CONCLUSIONS: Concomitant carotid endarterectomy and coronary artery bypass is a safe and effective procedure in patients with significant coronary and carotid artery disease. Equally good results can be reproduced using cardiopulmonary bypass or off-pump techniques for coronary artery surgery, with low morbidity, mortality, and good long-term results.

Comparative study of pulsatile and nonpulsatile flow during cardio-pulmonary bypass.

The use of nonpulsatile flow during extracorporeal circulation remains popular despite theoretical advantages of pulsatile cardiopulmonary bypass (CPB). Pulsatile CPB is considered to be more physiological than nonpulsatile flow as the pulsatile energy ensures the patency of the vascular bed and mechanical motion of tissue fluid around the cell membrane, improves microcirculation and enhances diffusion. The purpose of this study was to compare the effect of pulsatile and nonpulsatile flow on the coagulation profile, liver and kidney function and also on the haemodynamics in patients undergoing coronary artery bypass grafting on CPB. One hundred patients between 35 and 65 years of age with normal left ventricular function were randomly divided into two equal groups: Pulsatile (P) and nonpulsatile (NP). Haematological parameters, clotting profile, renal parameters, hepatic function tests and haemodynamic variables were measured preoperatively and postoperatively at specific intervals. Surgical, anaesthetic and CPB regimen was standard in all cases. There was a decrease in platelet count during and after CPB in both groups. Coagulation profile and renal function parameters remained similar in both groups except that creatinine clearance was better in group P on the first postoperative day. Urine output was also better in group P. There was no change in liver function tests in both groups. The haemodynamic variables were comparable in both groups. The systemic vascular resistance was higher in group NP postoperatively and oxygen consumption was higher in group P post CPB. In conclusion we did not find any significant difference between pulsatile and nonpulsatile flow during CPB except the creatinine clearance and urine output were better in pulsatile group.

A prospective evaluation of hemodynamic instability during off-pump coronary artery bypass surgery.

OBJECTIVE: Despite recognized hemodynamic derangements during cardiac displacement, most patients appear to tolerate the off-pump procedure well. However, some patients unpredictably become hemodynamically unstable requiring emergency cardiopulmonary bypass or intra-aortic balloon pump support. After an experience of 5306 multivessel off-pump coronary artery bypasses (OPCABs), this study was undertaken to determine the factors that would identify the patients who were at a higher risk for the procedure. DESIGN: Prospective clinical investigation. SETTING: Tertiary care academic cardiac care center. PARTICIPANTS: Five hundred consecutive patients undergoing multivessel OPCAB from September to December 2001. INTERVENTIONS: Various cardiac and extracardiac factors were charted in prespecified data-entry forms. Multiple logistic regression analysis was done to determine if any identifiable factors were predictors of a higher risk of unacceptable hemodynamic instability during OPCAB. Institution of IABP support or conversion to CPB were the endpoints of the study. MEASUREMENTS AND MAIN RESULTS: Of the 500 patients studied, significant hemodynamic instability developed in 24 (4.8%) patients. IABP support was instituted in 16 (3.2%) patients, and 8 (1.6%) were converted to CPB. Stepwise logistic regression identified ejection fraction <25% (p < 0.001), myocardial infarction of <1-month duration (p = 0.009), congestive heart failure (p = 0.016), and preoperative hemodynamic instability (p = 0.057) as predictors of conversion during OPCAB. CONCLUSIONS: Patients with low left ventricular ejection fraction <25%, myocardial infarction of <1-month duration, congestive heart failure, or preoperative hemodynamic instability constitute the high-risk group for OPCAB.

Multivessel off-pump coronary artery bypass: analysis of 4953 cases.

BACKGROUND: To avoid the harmful effects of cardiopulmonary bypass (CPB), cardiac surgeons are using off-pump coronary artery bypass (OPCAB) as an effective alternative to conventional coronary artery bypass grafting (CABG). In the present study, we analyze our results with OPCAB in patients with multivessel coronary artery disease and compare them with those achieved in patients who underwent operations on CPB. METHODS: Between January 1997 and April 2002, 4953 patients underwent CABG without CPB (OPCAB group). These patients were compared with 7133 patients who underwent conventional on-pump CABG (CCAB group) during the same period. All patients were operated on through a median sternotomy. The Octopus was used as the mechanical stabilizer, and intracoronary shunts were used in most patients. Transesophageal echocardiography was used in all patients, and epiaortic scanning was used in selected patients. RESULTS: The mean patient age was 59 +/- 8.9 years in the OPCAB group and 57.4 +/- 8.9 years in the CCAB group (P <.001). There were more women in the OPCAB group (11.7% versus 10.4%; P =.023), and 2.8% of the patients required conversion to CPB. The mean numbers of grafts were 3.0 +/- 0.7 and 3.2 +/- 0.8 in the OPCAB and the CCAB groups, respectively (P <.001). More patients in the CCAB group received grafts to the circumflex territory. Intubation times (19 +/- 4 hours versus 25 +/- 6 hours; P <.001), blood losses (350 +/- 41 mL versus 598 +/- 74 mL; P <.001), requirements for blood and blood products (30.8% versus 45.3%; P <.001), the frequency of reopening for bleeding (0.6% versus 2.8%; P <.001), requirements for postoperative intra-aortic balloon pump (1.3% versus 2.6%; P <.001), the frequency of atrial fibrillation OPCAB group. The mortality rate was 0.97% and 1.86% in the OPCAB and the CCAB groups, respectively (P <.001). Intensive care unit stays (23 +/- 6 hours versus 34 +/- 8 hours; P <.001) and hospital stays (5 +/- 2 days versus 8 +/- 3 days; P <.001) were significantly shorter in the OPCAB group. CONCLUSION: OPCAB is a safe and effective procedure for patients with multivessel coronary artery disease and is associated with reduced morbidity and mortality. However, large randomized studies with long-term follow-up may show the real benefits of OPCAB compared with CABG on CPB.

Surgical treatment of post infarction left ventricular aneurysms: our experience with double breasting and Dor's repair.

BACKGROUND: This is a retrospective study of left ventricle (LV) aneurysm repair done at the Escorts Heart Institute and Research Centre, New Delhi, since October 1988. Two methods of LV aneurysm repair are practiced: double breasting (DB) and Dor's repair. The method varies with location, size, and extent of aneurysm and quality of the fibrotic wall of the aneurysm. METHODS: Between October 1988 and May 2001, 129 patients underwent LV aneurysm repair using one of the two techniques; 78 patients had Dor's repair while 51 patients had DB repair. RESULTS: Overall mortality was 2.3% (three patients). One patient died in the DB group, and two patients died in the Dor's repair group. Mean preoperative ejection fraction (EF) after surgery in DB was 31% while in Dor's repair it was 29.2%. EF showed improvement after surgery to 48.5% in DB and 46.6% in Dor's repair. Decrease in end-diastolic volume (EDV) in DB was from 146 to 91.4 cm3/m2, and in Dor's repair it was from 156 cm3/m2 to 88.6 cm3/m2. Decrease in end-systolic volume was from 101 cm3/m2 to 60.2 cm3/m2 in DB and from 109 cm3/m2 to 64.5 cm3/m2 in Dor's group. All of these values showed statistically significant improvement. At six months postoperatively, 83 patients (74.1%) out of 112 patients who were preoperatively in New York Heart Association (NYHA) Functional Classes III and IV improved to class II while 7 patients (6.3%) improved to class I. CONCLUSION: In our experience Dor's repair is indicated for anteroseptal and apical isolated posterior aneurysm to restore LV volume and geometry while DB is indicated for apical, anterolateral, and lateral aneurysms where septal involvement is less. These two techniques have definite indications and advantages with good results.

Hemodynamic changes during displacement of the beating heart using epicardial stabilization for off-pump coronary artery bypass graft surgery.

OBJECTIVE: To evaluate the hemodynamic alterations during off-pump coronary artery bypass graft surgery to determine the degree of impairment caused and the techniques to rectify them. DESIGN: Prospective, observational cohort study performed from January 2000 through September 2000. PARTICIPANTS: Patients (n = 500) with coronary artery disease undergoing multivessel off-pump coronary artery bypass graft surgery using the Octopus tissue stabilizer (Medtronic, Inc, Minneapolis, MN). Unstable patients with ongoing ischemia were excluded from the study. INTERVENTIONS: All patients were monitored with radial artery and pulmonary artery catheters and continuous transesophageal echocardiography monitoring with a multiplane transducer. The perioperative requirement of an intracoronary shunt, inotropes, or an intra-aortic balloon pump was noted. The effect of the Trendelenburg position and fluids on hemodynamics was observed. The need for defibrillation and institution of emergency cardiopulmonary bypass were major endpoints to determine the inability of the patient to tolerate displacement of the heart. MEASUREMENTS AND MAIN RESULTS: Mean patient age was 59.3 +/- 11.6 years. There were 204 (40%) patients in the high-risk category; 54 (10.8%) patients had left ventricular ejection fraction <25%. The mean number of grafts was 2.7 +/- 0.8. Vertical displacement of the heart to access the lateral and inferior walls decreased the mean arterial pressure by 18 +/- 4% (p < 0.01), with a concomitant increase in central venous pressure of 66 +/- 18% (p < 0.001). The stroke volume and the cardiac index were reduced by 35.7 +/- 11% (p < 0.001) and 45 +/- 13% (p < 0.001). On transesophageal echocardiography, there was development of new regional wall motion abnormalities in 59.2% and a decrease in global left ventricular functions in 61.2%. The use of inotropes was highest during anastomosis on the posterior wall-78.4% compared with 21.9% for the anterior wall. An intra-aortic balloon pump was used in 55 (11.2%) patients, and 7 (0.71 %) patients had to be put on emergency CPB. The in-hospital mortality was 1.2%. CONCLUSION: Most patients had hemodynamic changes easily correctable by fluids and inotropes. Monitoring of left ventricular and right ventricular function by transesophageal echocardiography enhances safety of the procedure and is recommended. The use of the Octopus II tissue stabilizer proved to be a safe and versatile means to stabilize the heart during off-pump coronary artery bypass procedures, especially in high-risk patients.

Off-pump multivessel coronary artery surgery in high-risk patients.

BACKGROUND: Coronary artery bypass surgery on cardiopulmonary bypass is associated with significant morbidity and mortality, which may be more marked in high-risk patients. We evaluated our results of off-pump coronary artery bypass (OPCAB) in high-risk patients with multivessel coronary artery disease and compared them with results in similar patients who underwent operation on cardiopulmonary bypass. METHODS: A total of 1,075 patients who underwent OPCAB between October 1996 and June 2001 and who had one or more of the following risk factors were included in the study: poor left ventricular function (EF < or = 30%), advanced age (> 70 years), left main stenosis, acute myocardial infarction, and redo coronary artery surgery. These patients were compared with 2,312 similar patients who underwent coronary artery bypass grafting on cardiopulmonary bypass during the same period. Preoperative risk factors, intraoperative variables, and postoperative results were analyzed and compared between two groups. RESULTS: The average number of grafts was 3.0 +/- 0.4 and 3.2 +/- 0.3 in the off-pump (OPCAB) and on-pump (CCAB) groups, respectively. Hospital mortality was 3.2% and 4.5% in OPCAB and CCAB groups respectively (p = 0.109). Perioperative myocardial infarction, requirement of inotropic agents, stroke, and renal dysfunction were comparable in two groups. Intubation time (19 +/- 5 vs 24 +/- 6 hours, p < 0.001), mean blood loss (362 +/- 53 vs 580 +/- 66 mL, p < 0.001), atrial fibrillation (14.3 vs 19.7%, p < 0.001), and prolonged ventilation (4.6 vs 7.6%, p = 0.002) were less in OPCAB group. Intensive care unit stay (20 +/- 8 hours) and hospital stay (6 +/- 3 days) were significantly less in the OPCAB group (p < 0.001). CONCLUSIONS: Off-pump coronary artery surgery can be safely performed in high-risk patients with multivessel coronary artery disease. Operative mortality is comparable to that associated with on-pump surgery, and avoidance of cardiopulmonary bypass is associated with reduced postoperative morbidity in these patients.

Routine use of the radial artery for coronary artery revascularization.

Between January 1997 and December 2000, a total of 4,000 patients underwent myocardial revascularization using the radial artery as one of the conduits. The mean age of the patients was 54 +/- 7 years, and 92.8% of them were male. Of these patients, 31% had a left ventricular ejection fraction below 40% and 22.8% underwent urgent operation. A total of 4,225 distal anastomoses were performed using the radial artery. The average number of grafts was 3.3 +/- 0.5. The hospital mortality rate was 0.8%. Low cardiac output, inotropic support, perioperative myocardial infarction, reoperation for bleeding, atrial fibrillation, and sternal infection occurred in 1.8%, 2.8%, 1.2%, 1.2%, 16.8%, and 1.2% of the patients, respectively. None of the patients had major ischemia of the hand. The incidence of local hand wound complications was 0.7% (wound infection, 0.4%; wound dehiscence without infection, 0.1%; and hematoma, 0.2%). The average length of stay in the intensive care unit was 20 +/- 7 hours and in the hospital was 6 +/- 2 days. Postoperative angiography, performed in 106 patients at a mean interval of 18 months, showed that 92.4% of radial artery, 96.2% of internal mammary artery, and 76.2% of saphenous vein grafts were patent.

Beating heart versus conventional reoperative coronary artery bypass surgery.

BACKGROUND: The incidence of reoperative coronary artery bypass grafting is increasing with an increase in the number of patients undergoing coronary artery bypass surgery. The clinical outcome of redo coronary artery bypass grafting without cardiopulmonary bypass and conventional coronary artery bypass grafting using cardiopulmonary bypass are different. METHODS AND RESULTS: We compared clinical parameters in patients who underwent off-pump (n=156) versus on-pump (n=194) redo coronary artery bypass grafting performed between January 1995 and December 2001 in our institute, to determine if off-pump surgery has improved the surgical outcome of redo coronary artery bypass grafting and emerged as an ideal technique. Patients who underwent on-pump redo surgery required more postoperative blood transfusion (86.53% on-pump v. 12.82% off-pump. p=0.001), prolonged ventilatory support (>24 hours) (16.49% on-pump v. 7.7% off-pump, p=0.021) and higher inotropic support (23.71% on-pump v. 10.89% off-pump, p=0.003). On-pump redo coronary artery bypass grafting was also associated with a prolonged stay in the intensive care unit (40+/-6.2 hours on-pump v. 20+/-4.1 hours off-pump, p=0.001) and longer hospital stay (9+/-4.2 days on-pump v. 5+/-3.4 days off-pump, p=0.001). In-hospital mortality was higher in on-pump patients than in off-pump ones (7.7% v. 3.2%); however, this was not statistically significant (p=0.114). CONCLUSIONS: Off-pump redo coronary artery bypass grafting is a safe method of myocardial revascularization with lower operative morbidity and mortality, less requirement of blood products and early hospital discharge, compared with conventional on-pump redo coronary artery bypass grafting.

Vascular complications of intra-aortic balloon insertion in patients undergoing coronary reavscularization: analysis of 911 cases.

OBJECTIVE: Intra-aortic balloon pump (IABP) is a well-accepted and widely used mechanical circulatory support in cardiac surgical practice. We evaluated the vascular complications of IABP and risk factors associated with the development of these complications in patients undergoing myocardial revascularization. METHODS: Between January 1994 and December 2000, a total of 911 patients undergoing coronary artery bypass grafting received IABP. The preoperative risk factors, balloon-related variables and vascular complications were studied and analyzed. Univariate and multivariate analyses were performed to identify risk factors for the development of vascular complications. RESULTS: Mean age of the patients was 59.2+/-9.1 years and 10.5% of the patients were female. The incidence of diabetes and peripheral vascular disease was 41.1 and 8.5%, respectively. The mean Parsonnet score was 11.8+/-4.6. IABP was inserted by percutaneous technique in 96.8% of patients. The duration of IABP therapy ranged from 20 h to 21 days (mean 3.8 days). Fifty-four (5.9%) patients developed major and 53 (5.8%) patients developed minor vascular complications. Ischaemia of the limb, requiring thromboembolectomy, developed in 25 (2.7%) patients. Patients who received IABP preoperatively had higher incidence of major vascular complications as compared to patients who received IABP in operating room before induction of anaesthesia. Multiple logistic regression analysis revealed age, triple vessel disease, indications of IABP therapy (unstable angina, cardiac arrhythmia and haemodynamic instability), left ventricular aneurysm surgery and use of balloon with sheath as independent risk factors for the development of vascular complications. CONCLUSIONS: IABP therapy is associated with certain vascular complications, which should always be kept in mind before insertion of a balloon. The use of a balloon without sheath and proper evaluation of peripheral circulation can help to minimize the development of vascular complications.

Off-pump coronary artery bypass grafting in patients with left ventricular dysfunction.

BACKGROUND: Coronary artery bypass grafting in patients with severe left ventricular (LV) dysfunction still remains a high risk procedure due to its high mortality and morbidity. Off-pump surgery can be an alternative technique in these patients. We analyzed our results of off-pump coronary surgery in patients with left ventricular dysfunction and compared them with patients operated on-pump. METHODS: Between January 1997 and December 2000, 355 patients with LV dysfunction (EF equal to or less than 30%) underwent off-pump coronary artery bypass (OPCAB) surgery. During the same period, 959 patients with LV dysfunction underwent coronary artery surgery on cardiopulmonary bypass. Octopus was used as mechanical stabilizer and intracoronary shunts were used in most patients. The mean age of the patients was 57.7 +/- 9.2 in patients operated on-pump and 58.4 +/- 9.8 in patients operated off-pump. RESULTS: The preoperative variables were comparable in two groups, except that there were more patients with triple vessel disease in on-pump group. Average number of grafts was 2.8 +/- 0.7 and 3.3 +/- 0.7 (p<0.001) in off-pump and on-pump groups respectively. The mortality was 3.9% and 6.0% (p = 0.176) in off-pump and on-pump groups respectively. Postoperative morbidity was less in off-pump group but it was statistically significant in incidence of atrial fibrillation and prolonged ventilation which were low in off-pump group. The hospital stay was significantly less in patients operated off-pump. CONCLUSION: OPCAB surgery can be safely performed in patients with LV dysfunction. The postoperative morbidity and length of stay is less as compared to patients operated on-pump.

Safety and efficacy of one stage off-pump coronary artery operation and carotid endarterectomy.

BACKGROUND: Patients with concomitant occlusive disease of coronary and carotid arteries remain at high risk of perioperative stroke and myocardial infarction. Combined coronary artery bypass grafting on cardiopulmonary bypass and carotid endarterectomy has been shown to give good results for this category of patients. In the present study, we analyzed our results of off-pump coronary artery bypass grafting and carotid endarterectomy as a one-stage procedure. METHODS: Between January 1997 and December 2000, 82 patients underwent combined off-pump coronary artery bypass grafting and carotid endarterectomy. All patients were evaluated by preoperative carotid duplex scanning and carotid angiography. All patients had more than or equal to 70% carotid artery stenosis. There were 35 asymptomatic patients (42.7%) and 47 symptomatic patients (57.3%). Carotid endarterectomy was performed before coronary artery bypass grafting in all the patients. RESULTS: There were 66 males (80.5%) and 16 females (19.5%) with a mean age of 63+/-8 years. The average number of grafts was 3.4+/-0.8. There was no hospital mortality. One patient had perioperative myocardial infarction. None of the patients had stroke. One patient had transient neurologic deficit and 1 patient had temporary 12th nerve dysfunction; both recovered completely. There was no incidence of neck wound infection, although 1 patient developed neck hematoma that required reexploration. At a mean follow-up of 2.2+/-0.7 years, 1 patient required contralateral carotid endarterectomy and 1 patient died because of cardiac failure. CONCLUSIONS: Combined off-pump coronary artery bypass grafting and carotid endarterectomy is a safe and effective procedure in patients with significant concomitant carotid and coronary artery disease.