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1.
Front Cardiovasc Med ; 11: 1393762, 2024.
Article in English | MEDLINE | ID: mdl-38873269

ABSTRACT

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.

2.
Indian J Thorac Cardiovasc Surg ; 38(3): 300-303, 2022 May.
Article in English | MEDLINE | ID: mdl-35529003

ABSTRACT

Björk-Shiley tilting disc prosthesis was the first tilting disc prosthesis to be used worldwide on a large-scale basis. Herein, we report a case of a 67-year-old male presenting with severe prosthetic valvular dysfunction. He had undergone mitral valve replacement with Björk-Shiley valve at some other center in 1987. The surgical challenge was to replace that with an adequately sized prosthesis. To achieve that, we removed all the previously preserved posterior cusp and then reconstructed the sub-valvular apparatus. The patient had a smooth post-operative recovery. This case report highlights the longest reported survival of a Björk-Shiley mitral valve and specific challenges faced during such redo cases.

3.
Curr Opin Cardiol ; 36(6): 735-739, 2021 11 01.
Article in English | MEDLINE | ID: mdl-34456253

ABSTRACT

PURPOSE OF REVIEW: Less invasive multivessel coronary artery bypass grafting techniques have seen a progressive evolution over the last two decades. In their current state, they are easily reproduced and applicable to most patients requiring multivessel revascularization. The purpose of this review is to highlight their importance among a spectrum of evolving therapies and the accruing evidence in their favour. RECENT FINDINGS: The first large dual center experience with minimally invasive coronary artery bypass grafting (MICS CABG) demonstrated the feasibility of performing multivessel surgical revascularization without the need for sternotomy or cardiopulmonary bypass. Subsequent angiographic studies to assess graft patency showed excellent early results. Studies comparing MICS CABG to conventional CABG demonstrate faster recovery while reducing hospitalization and cost. SUMMARY: Multivessel less invasive coronary artery bypass grafting is basically limited to two procedures, MICS CABG and robotically assisted totally endoscopic CABG (TECAB). MICS CABG has evolved as a procedure that preserves the safety and efficacy of conventional CABG while avoiding the associated morbidity. It is reproducible, versatile and holds promise as the procedure of choice for multivessel coronary revascularization in the future. TECAB is likely the pinnacle of minimally invasive coronary surgery, the growth of which is hindered by widespread acceptance and industry involvement.


Subject(s)
Coronary Artery Bypass , Minimally Invasive Surgical Procedures , Cardiopulmonary Bypass , Endoscopy , Humans
4.
J Cardiothorac Surg ; 15(1): 140, 2020 Jun 15.
Article in English | MEDLINE | ID: mdl-32539847

ABSTRACT

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).


Subject(s)
Aortic Valve Insufficiency/surgery , Aortic Valve Stenosis/surgery , Bioprosthesis , Heart Valve Prosthesis , Hemodynamics , Adult , Aged , Aged, 80 and over , Animals , Aortic Valve/surgery , Cattle , Female , Follow-Up Studies , Heart Valve Prosthesis Implantation , Humans , Male , Middle Aged , Mitral Valve/surgery , Pericardium/surgery , Postoperative Period , Prospective Studies , Quality of Life , Stents , Treatment Outcome
5.
Contemp Clin Trials ; 78: 140-145, 2019 03.
Article in English | MEDLINE | ID: mdl-30634037

ABSTRACT

RATIONALE: Minimally invasive cardiac surgery has emerged as a safe alternative to standard cardiac surgery. Minimally invasive coronary surgery (MICS CABG) was developed to allow adequate exposure and complete revascularization in CABG from a small thoracotomy incision without cardiopulmonary bypass. Multiple studies have reported significant shorter length of hospital stay and earlier postoperative physical recovery for MICS CABG patients when compared to sternotomy CABG patients. However, there have been no convincing clinical trials that demonstrate improvement in post-operative quality of life for patients who undergo MICS CABG. STUDY DESIGN: The Minimally Invasive Coronary Surgery compared to Sternotomy Coronary Artery Bypass Grafting (MIST) trial is a multi-centered, prospective randomized controlled trial that compares the quality of life and recovery in the early post-operative period between patients undergoing MICS CABG versus patients undergoing sternotomy CABG. Patients will be randomized either to the MICS CABG group or the sternotomy CABG group, and the target enrollment is 88 patients per group. The primary outcome is quality of life assessment performed by SF-36 questionnaire at 1 month. CONCLUSION: The MIST trial is the first prospective study that compares the quality of life between MICS CABG and sternotomy CABG patients. The results of this trial may enhance the procedural desirability of MICS CABG by patients and provide an incentive for surgeons and institutions to increase the availability of MICS CABG in suitable patients.


Subject(s)
Coronary Artery Bypass/methods , Minimally Invasive Surgical Procedures/methods , Quality of Life , Sternotomy/methods , Thoracotomy/methods , Adolescent , Adult , Aged , Emotions , Female , Humans , Length of Stay , Male , Mental Health , Middle Aged , Operative Time , Physical Functional Performance , Postoperative Complications/epidemiology , Prospective Studies , Young Adult
7.
Indian J Thorac Cardiovasc Surg ; 35(Suppl 1): 3-44, 2019 Jan.
Article in English | MEDLINE | ID: mdl-33061064

ABSTRACT

PURPOSE: Valvular heart disease (VHD) patients after prosthetic valve implantation are at risk of thromboembolic events. Follow-up care of patients with prosthetic valve has a paramount role in reducing the morbidity and mortality. Currently, in India, there is quintessential need to stream line the follow-up care of prosthetic valve patients. This mandates the development of a consensus guideline for the antithrombotic therapy in VHD patients post prosthetic valve implantation. METHODS: A national level panel was constituted comprising 13 leading cardio care experts in India who thoroughly reviewed the up to date literature, formulated the recommendations, and developed the consensus document. Later on, extensive discussions were held on this draft and the recommendations in 8 regional meetings involving 79 additional experts from the cardio care in India, to arrive at a consensus. The final consensus document is developed relying on the available evidence and/or majority consensus from all the meetings. RESULTS: The panel recommended vitamin K antagonist (VKA) therapy with individualized target international normalized ratio (INR) in VHD patients after prosthetic valve implantation. The panel opined that management of prosthetic valve complications should be personalized on the basis of type of complications. In addition, the panel recommends to distinguish individuals with various co-morbidities and attend them appropriately. CONCLUSIONS: Anticoagulant therapy with VKA seems to be an effective option post prosthetic valve implantation in VHD patients. However, the role for non-VKA oral therapy in prosthetic valve patients and the safety and efficacy of novel oral anticoagulants in patients with bioprosthetic valve need to be studied extensively.

8.
J Assoc Physicians India ; 66(1): 59-74, 2018 01.
Article in English | MEDLINE | ID: mdl-30341847

ABSTRACT

Background: Prosthetic valve implantation requires postoperative prophylactic anticoagulation to preclude thrombotic events. The aim of this review is to assess the role of anticoagulation therapy in the management of valve replacement patients. Methodology: Literature from PubMed, Embase, Medline and Google Scholar were searched using the terms "valvular heart disease", "anticoagulant", "mechanical heart valve", "bioprosthesis", "bridging", "Vitamin K antagonist (VKA)", and "acenocoumarol". A committee comprising leading cardiothoracic surgeons from India was convened to review the literature and suggest key practice points. Results: Prosthetic valve implantation requires postoperative prophylactic anticoagulation to preclude thrombotic events. A paramount risk of thromboembolic events is observed during the first three months after surgery for both mechanical and bioprosthetic devices. The VKA therapy with individualized target international normalized ratio (INR) is recommended in patients after prosthetic valve replacement. Therapies for the management of prosthetic valve complications should be based on the type of complications. Special care is mandated in distinguished individuals and those with various co-morbidities. Conclusion: In patients with prosthetic valve replacement, anticoagulant therapy with VKA seems to be an effective option. The role for non-VKA oral anticoagulants in the setting of prosthetic valve replacement has yet to be established. Furthermore, whether the novel oral anticoagulants are safe and efficacious in patients after placement of a bioprosthetic valve remains unanswered.


Subject(s)
Anticoagulants/therapeutic use , Heart Valve Prosthesis Implantation , Postoperative Complications/prevention & control , Thromboembolism/prevention & control , Heart Valve Prosthesis , Hemorrhage/chemically induced , Hemorrhage/therapy , Humans , International Normalized Ratio , Risk Assessment
9.
J Cardiothorac Surg ; 13(1): 96, 2018 Sep 25.
Article in English | MEDLINE | ID: mdl-30253784

ABSTRACT

BACKGROUND: Indian patients undergoing surgical aortic valve replacement (SAVR) differ from western populations with respect to aortic annulus size and valve disease morphology. The purpose of this post-market, non-randomized observational study was to evaluate the early hemodynamic performance of the Trifecta™ bioprosthesis (Abbott, previously St. Jude Medical, Minneapolis, US) in an Indian patient population. METHODS: From January 2014 to September 2015, 100 patients (mean age 64.4 ± 7.1 years, 62% male) undergoing SAVR for valve disease (68% stenosis, 7% insufficiency, 25% mixed pathology) were enrolled across 10 centers in India. Patients implanted with a 19-27 mm Trifecta™ valve were eligible to participate and were prospectively followed for 12-months post-implantation. Echocardiographic hemodynamic performance was evaluated at pre-implant, pre-discharge and at 12-months by an independent core laboratory. Adverse events were adjudicated by the study sponsor. Functional status at 12-months was assessed according to NYHA classification. Continuous data was summarized using descriptive statistics (mean &standard deviation,) and categorical data was summarized using frequencies and percentages. RESULT: Ninety patients (mean age 64.5, 62.2% male) completed the 12-month follow up. Significant improvements in hemodynamic valve performance were reported in 81 patients with available echocardiographic data at 12 months. Compared to baseline at 12-month follow up visit, mean effective orifice area increased from 0.75cm2 to 1.61cm2 (p < 0.0001), mean pressure gradient reduced to 10.42 mmHg from 51.47 mmHg (p < 0.0001), cardiac output increased from 4.46 l/min to 4.85 l/min (P 0.9254). Compared to baseline, functional status improved by ≥1 NYHA class in 75% of patients at 12 months (95% Clopper-Pearson (Exact) confidence limit [64.6%, 83.6%]). No instances of early mortality (< 30 days from index procedure) or structural valve dysfunction were reported. CONCLUSION: In an Indian patient population, implantation of the Trifecta™ bioprosthesis is shown to be safe and associated with favorable early hemodynamic performance and improved functional status at 12 months. TRIAL REGISTRATION: The clinical study has been registered under Clinical Trial Registry-India ( http://www.ctri.nic.in ) and registration number is CTRI/2014/02/004434 registered on 25 February 2014 retrospectively registered.


Subject(s)
Aortic Valve/surgery , Bioprosthesis , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis , Aged , Aged, 80 and over , Aortic Valve/physiopathology , Aortic Valve Insufficiency/physiopathology , Aortic Valve Insufficiency/surgery , Aortic Valve Stenosis/physiopathology , Aortic Valve Stenosis/surgery , Echocardiography , Female , Follow-Up Studies , Hemodynamics/physiology , Humans , Male , Middle Aged , Retrospective Studies , Time Factors
10.
Indian J Thorac Cardiovasc Surg ; 34(Suppl 3): 310-320, 2018 Dec.
Article in English | MEDLINE | ID: mdl-33060954

ABSTRACT

BACKGROUND: In patients with advanced coronary artery disease (CAD), coronary artery bypass grafting (CABG) is associated with improved long-term outcomes while percutaneous coronary intervention (PCI) is associated with lower periprocedural complications. A new approach has emerged in the last decade that attempts to reap the benefits of bypass surgery and stenting while minimizing the shortcomings of each approach, hybrid myocardial revascularization (HMR).Three strategies for timing of the hybrid revascularization exists, each with their own inherent advantages and shortcomings: (1) CABG followed by PCI, (2) PCI followed by CABG, or (3) simultaneous CABG + PCI in a hybrid suite. STUDIES: The results of the first randomized control trial comparing HMR (CABG first) and standard CABG, POL-MIDES (Prospective Randomized PilOt Study EvaLuating the Safety and Efficacy of Hybrid Revascularization in MultIvessel Coronary Artery DisEaSe), show HMR was feasible for 93.9% of patients whereas conversion to standard CABG was required for 6.1%. At 1 year, both groups had similar all-cause mortality (CABG 2.9% vs. HMR 2%) and major adverse clinical event (MACE)-free survival rates (CABG 92.2% vs. HMR 89.8%). Results of observational and comparative studies show that minimally invasive HMR procedures in patients with multivessel CAD carry minimal perioperative mortality risk and low morbidity and do not increase the risk of postoperative bleeding. The advantage they offer in comparison to classical surgical revascularization is indeed faster rehabilitation and patient's return to normal life. CONCLUSION: Hybrid myocardial revascularization has been developed as a promising technique for the treatment of high-risk patients with CAD. Hybrid revascularization using minimally invasive surgical techniques combined with PCI offers to a part of patients an advantage of optimal revascularization of the most important artery of the heart, together with adequate myocardial revascularization in a relatively delicate way. Indeed, to patients with high operative risk of standard surgery, it offers an alternative which should be considered carefully.

11.
Ann Cardiothorac Surg ; 2(6): 733-8, 2013 Nov.
Article in English | MEDLINE | ID: mdl-24349974

ABSTRACT

BACKGROUND: Minimally invasive mitral valve surgery (MIMVS) has become a standard technique to perform mitral valve surgery in many cardiac centers. However, there remains a question regarding when MIMVS should not be performed due to an increased surgical risk. Consequently, expert surgeons were surveyed regarding their opinions on patient factors, mitral valve pathology and surgical skills in MIMVS. METHODS: Surgeons experienced in MIMVS were identified through an electronic search of the literature. A link to an online survey platform was sent to all surgeons, as well as two follow-up reminders. Survey responses were then submitted to a central database and analyzed. RESULTS: The survey was completed by 20 surgeons. Overall results were not uniform with regard to contraindications to performing MIMVS. Some respondents do not consider left atrial enlargement (95% of surgeons), complexity of surgery (75%), age (70%), aortic calcification (70%), EuroSCORE (60%), left ventricular ejection fraction (55%), or obesity (50%) to be contraindication to surgery. Ninety percent of respondents believe more than 20 cases are required to gain familiarity with the procedure, while 85% believe at least one MIMVS case needs to be performed per week to maintain proficiency. Eighty percent recommend establishment of multi-institutional databases and standardized surgical mentoring courses, while 75% believe MIMVS should be incorporated into current training programs for trainees. CONCLUSIONS: These results suggest that MIMVS has been accepted as a treatment option for patients with mitral valve pathologies according the expert panel. Initial training and continuing practice is recommended to maintain proficiency, as well as further research and formalization of training programs.

12.
J Anaesthesiol Clin Pharmacol ; 29(2): 248-51, 2013 Apr.
Article in English | MEDLINE | ID: mdl-23878452

ABSTRACT

Valvular heart disease in systemic lupus erythematosus (SLE) is associated with substantial morbidity and mortality. Current therapy includes symptomatic measures and valve replacement. SLE can present major challenges because of accrued organ damage, coagulation defects and complex management regimes. The peri-operative goals are to maintain strict asepsis, avoid use of nephrotoxic drugs and thereby renal insult, and to promote early ambulation post-operatively.

13.
J Thorac Cardiovasc Surg ; 141(1): 91-7, 2011 Jan.
Article in English | MEDLINE | ID: mdl-21168015

ABSTRACT

OBJECTIVE: Functional ischemic mitral regurgitation is a complication of ventricular remodeling; standard therapy is reduction annuloplasty and coronary artery bypass grafting. Unfortunately, outcomes are retrospective and contradictory. We report a multicenter study that documents the outcomes of reduction annuloplasty for functional ischemic mitral regurgitation. METHODS: Twenty-one centers randomized 75 patients to the coronary artery bypass grafting + reduction annuloplasty subgroup that was the control arm of the Randomized Evaluation of a Surgical Treatment for Off-pump Repair of the Mitral Valve trial. Entry criteria included patients requiring revascularization, patients with severe or symptomatic moderate functional ischemic mitral regurgitation, an ejection fraction 25% or greater, a left ventricular end-diastolic dimension 7.0 cm or less, and more than 30 days since acute myocardial infarction. All echocardiograms were independently scored by a core laboratory. Reduction annuloplasty was achieved by device annuloplasty. Two patients underwent immediate intraoperative conversion to a valve replacement because reduction annuloplasty was unable to correct mitral regurgitation; as-treated results are presented. RESULTS: Thirty-day mortality was 4.1% (3/73). Patients received an average of 2.8 bypass grafts. Mean follow-up was 24.6 months. Mitral regurgitation was reduced from 2.6 ± 0.8 preoperatively to 0.3 ± 0.6 at 2 years. Freedom from death or valve reoperation was 78% ± 5% at 2 years. There was significant improvement in ejection fraction and New York Heart Association class with reduction of left ventricular end-diastolic dimension. Cox regression analyses suggested that increasing age (P = .001; hazard ratio, 1.16 per year; 95% confidence interval, 1.06-1.26) and renal disease (P = .018; hazard ratio, 3.48; 95% confidence interval, 1.25-9.72) were associated with decreased survival. CONCLUSIONS: Coronary artery bypass grafting + reduction annuloplasty for functional ischemic mitral regurgitation predictably reduces mitral regurgitation and relieves symptoms. This treatment of moderate to severe mitral regurgitation is associated with improved indices of ventricular function, improved New York Heart Association class, and excellent freedom from recurrent mitral insufficiency. Although long-term prognosis remains guarded, this multicenter study delineates the intermediate-term benefits of such an approach.


Subject(s)
Coronary Artery Bypass , Heart Valve Prosthesis Implantation , Mitral Valve Annuloplasty , Mitral Valve Insufficiency/surgery , Myocardial Ischemia/complications , Aged , Coronary Artery Bypass/adverse effects , Coronary Artery Bypass/mortality , Early Termination of Clinical Trials , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/mortality , Humans , Middle Aged , Mitral Valve Annuloplasty/adverse effects , Mitral Valve Annuloplasty/mortality , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/etiology , Mitral Valve Insufficiency/mortality , Mitral Valve Insufficiency/physiopathology , Myocardial Ischemia/diagnostic imaging , Myocardial Ischemia/mortality , Myocardial Ischemia/physiopathology , Proportional Hazards Models , Prospective Studies , Recovery of Function , Reoperation , Risk Assessment , Risk Factors , Severity of Illness Index , Stroke Volume , Time Factors , Treatment Outcome , Ultrasonography , United States , Ventricular Function, Left , Ventricular Remodeling
14.
J Am Coll Cardiol ; 56(24): 1984-93, 2010 Dec 07.
Article in English | MEDLINE | ID: mdl-21126639

ABSTRACT

OBJECTIVES: we sought to determine whether patients with functional mitral regurgitation (FMR) would benefit from ventricular reshaping by the Coapsys device (Myocor, Inc., Maple Grove, Minnesota). BACKGROUND: FMR occurs when ventricular remodeling impairs valve function. Coapsys is a ventricular shape change device placed without cardiopulmonary bypass to reduce FMR. It compresses the mitral annulus and reshapes the ventricle. We hypothesized that Coapsys for FMR would improve clinical outcomes compared with standard therapies. METHODS: RESTOR-MV (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve) was a randomized, prospective, multicenter study of patients with FMR and coronary disease with core laboratory analysis. After enrollment, patients were stratified to the standard indicated surgery: either coronary artery bypass graft alone or coronary artery bypass graft with mitral valve repair. In each stratum, randomization was to either control (indicated surgery) or treatment (coronary artery bypass graft with Coapsys ventricular reshaping). RESULTS: the study was terminated when the sponsor failed to secure ongoing funding; 165 patients were randomized. Control and Coapsys both produced decreases in left ventricular (LV) end-diastolic dimension and MR at 2 years (p < 0.001); Coapsys provided a greater decrease in LV end-diastolic dimension (p = 0.021). Control had lower MR grades during follow-up (p = 0.01). Coapsys showed a survival advantage compared with control at 2 years (87% vs. 77%) (hazard ratio: 0.421; 95% confidence interval: 0.200 to 0.886; stratified log-rank test; p = 0.038). Complication-free survival (including death, stroke, myocardial infarction, and valve reoperation) was significantly greater with Coapsys at 2 years (85% vs. 71%) (hazard ratio: 0.372; 95% confidence interval: 0.185 to 0.749; adjusted log-rank test; p = 0.019). CONCLUSIONS: analysis of RESTOR-MV indicates that patients with FMR requiring revascularization treated with ventricular reshaping rather than standard surgery had improved survival and a significant decrease in major adverse outcomes. This trial validates the concept of the ventricular reshaping strategy in this subset of patients with heart failure. (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve [RESTOR-MV]; NCT00120276).


Subject(s)
Heart Ventricles , Heart-Assist Devices , Mitral Valve Insufficiency/surgery , Aged , Female , Follow-Up Studies , Humans , Male , Middle Aged , Treatment Outcome
16.
Ann Card Anaesth ; 13(1): 39-43, 2010.
Article in English | MEDLINE | ID: mdl-20075534

ABSTRACT

Antiphospholipid antibody syndrome (APLAS) characterises a clinical condition of arterial and venous thrombosis associated with phospholipids directed antibodies. APLAS occurs in 2% of the general population. However, one study demonstrated that 7.1% of hospitalised patients were tested positive for at least one of the three anticardiolipin antibody idiotype. Antiphospholipid antibodies often inhibit phospholipids dependent coagulation in vitro and interfere with laboratory testing of hemostasis. Therefore, the management of anticoagulation during cardiopulmonary bypass can be quite challenging in these patients. Here, we present a case of right atrial mass removal and pulmonary thrombectomy in a patient of APLAS.


Subject(s)
Anesthesia/methods , Antiphospholipid Syndrome/surgery , Pulmonary Artery/surgery , Pulmonary Embolism/surgery , Thrombectomy , Adult , Echocardiography, Transesophageal , Female , Heart Atria , Humans
17.
Ann Card Anaesth ; 11(2): 91-6, 2008.
Article in English | MEDLINE | ID: mdl-18603748

ABSTRACT

Minimally invasive surgery with robotic assistance should elicit minimal pain. Regional analgesic techniques have shown excellent analgesia after thoracotomy. Thus the aim of this study was to compare thoracic epidural analgesia (TEA) technique with paravertebral block (PVB) technique in these patients with regard to quality of analgesia, complications, and haemodynamic and respiratory parameters. This was a prospective randomised study involving 36 patients undergoing elective robotic-assisted coronary artery bypass grafting (CABG). TEA or PVB were administered in these patients. The results revealed no significant differences with regard to demographics, haemodynamics, and arterial blood gases. Pulmonary functions were better maintained in PVB group postoperatively; however, this was statistically insignificant. The quality of analgesia was also comparable in both the groups. We conclude that PVB is a safe and effective technique for postoperative analgesia after robotic-assisted CABG and is comparable to TEA with regard to quality of analgesia.


Subject(s)
Analgesia, Epidural/methods , Coronary Artery Bypass/methods , Minimally Invasive Surgical Procedures/methods , Nerve Block/methods , Robotics , Analgesia, Epidural/adverse effects , Female , Humans , Male , Middle Aged , Nerve Block/adverse effects , Pain Measurement , Postoperative Complications , Prospective Studies , Respiratory Function Tests , Treatment Outcome
18.
J Thorac Cardiovasc Surg ; 135(3): 527-32, 2008 Mar.
Article in English | MEDLINE | ID: mdl-18329464

ABSTRACT

OBJECTIVE: Patients undergoing reoperative coronary artery bypass have increased mortality and morbidity compared with those undergoing primary coronary bypass. The experience in applying off-pump techniques to coronary reoperations is limited. In this article we report a 10-year experience using various techniques of reoperative off-pump coronary bypass. METHODS: Between January 1996 and December 2005, 332 patients underwent reoperative off-pump coronary artery bypass grafting. Data were collected regarding the preoperative, intraoperative, and postoperative clinical course of all patients. These were compared with similar data obtained from patients who had undergone conventional coronary reoperation during this period. RESULTS: Two hundred ninety-six (89.2%) male and 36 female patients underwent reoperative off-pump coronary artery bypass. Of these, 265 (79.8%) patients underwent multivessel bypass through a median sternotomy, an anterolateral thoracotomy was performed in 63 (19%) patients, and a posterolateral thoracotomy was performed in 4 (1.2%) patients. The early mortality for patients undergoing off-pump surgery was lower than for those undergoing conventional reoperations (3.3% vs 5.5%, P = .066). Those who had undergone off-pump reoperations had less need for prolonged ventilation or prolonged inotropic support and had shorter intensive care unit and hospital stays than patients who had undergone redo coronary artery bypass grafting. CONCLUSION: For many patients requiring coronary reoperations, off-pump techniques are safe and feasible. Complete revascularization was achieved in at least 75% of patients in an unselected population, with mortality and perioperative event rates that are comparable with those of conventionally performed coronary reoperations.


Subject(s)
Coronary Artery Bypass, Off-Pump/mortality , Coronary Disease/mortality , Coronary Disease/surgery , Hospital Mortality/trends , Aged , Cardiac Catheterization , Coronary Angiography , Coronary Artery Bypass/methods , Coronary Artery Bypass/mortality , Coronary Artery Bypass, Off-Pump/methods , Coronary Disease/diagnostic imaging , Feasibility Studies , Female , Follow-Up Studies , Humans , Male , Middle Aged , Postoperative Complications/mortality , Probability , Reoperation , Retrospective Studies , Risk Assessment , Severity of Illness Index , Statistics, Nonparametric , Survival Analysis , Thoracotomy/methods , Time Factors , Treatment Outcome
20.
Indian Heart J ; 60(2): 125-32, 2008.
Article in English | MEDLINE | ID: mdl-19218721

ABSTRACT

BACKGROUND: Although, conventional surgical closure of atrial septal defect (ASD) provides excellent results with very low mortality and morbidity, it leaves the scar of incision and postoperative pain. Newer treatment modalities like minimal invasive surgery and percutaneous closure are being increasingly used nowadays where available. AIM: To compare the patient population, success, safety, and efficacy of transcatheter closure of ASD (Group A) with that of minimally invasive surgery (Port Access) (Group B). METHODS: In this retrospective non-randomized study, a record of a total of 640 patients with diagnosis of ASD secundum between May 1997 and October 2006 were reviewed. A total of 470 out of 640 patients were selected for transcatheter closure (Group A) while 170 patients were taken for surgical closure by minimally invasive port access surgery (Group B). The safety and efficacy of two groups was evaluated on the basis of morbidity and mortality, duration of intensive care unit (ICU) stay, total duration of hospital stay, post-procedural complications, residual sequel at time of discharge, and residual flow across the ASD. RESULTS: Success rate in two groups was 97.1% and 99.4%, respectively and had no statistically significant difference. Similarly major complication rate also had no difference in statistical significance (1.8% and 2.9% for Group A and B, respectively). Group B patients had longer hospital stay. A small but significant number of patients were not found suitable for device closure. This number is likely to decrease as experience with technique increases. Port access surgery is currently not possible in small children (femoral artery diameter 35 mm) due to difficulty in cannulation. CONCLUSION: Percutaneous device closure of ASD can be offered as a treatment option in suitable patients. Port access is minimally invasive and an equally safe and effective alternative choice in ASDs with deficient rim in patient with appropriate age and weight.


Subject(s)
Cardiac Catheterization/methods , Heart Septal Defects, Atrial/therapy , Adolescent , Adult , Aged , Cardiac Care Facilities , Child , Child, Preschool , Female , Heart Septal Defects, Atrial/diagnostic imaging , Heart Septal Defects, Atrial/pathology , Heart Septal Defects, Atrial/surgery , Humans , Length of Stay , Male , Middle Aged , Minimally Invasive Surgical Procedures/methods , Retrospective Studies , Treatment Outcome , Ultrasonography , Young Adult
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