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.

In the VEST trial: are we missed to address the pathology incurred by the external stent?

In the VEST IV trial, the author concluded that external stenting of saphenous vein graft mitigates its remodeling and also significantly reduces the diffuse intimal hyperplasia and development of lumen irregularities at 4.5 years after coronary artery bypass grafting surgery. We also have valuable a suggestion in addition to external stenting that might nullify the pathology caused by the stent and might enhances graft patency.

Technical Aspects: Coronary Artery Bypass Grafting in a Case of Dextrocardia With Situs Inversus.

Dextrocardia with situs inversus is a rare congenital anomaly in which the heart and the abdominal organs orient themselves in a mirror-image reversal of the normal anatomy. Coronary artery disease incidence is similar to that of the normal population. Performing coronary artery bypass grafting in this subset of the population poses few difficulties. These limitations can be overcome by few technical adjustments by the surgeon and the team which will be discussed in our article.

Weight gain potential-a neglected entity during valve replacement.

INTRODUCTION: During valve replacement, appropriate valve size will be chosen based on many factors, neglecting the potential of the patient for gaining weight. We aimed at evaluating the weight gain potential and its effect on hemodynamics in post mitral valve replacement (MVR) patients. MATERIAL AND METHODS: In 118 post-MVR patients, demographic and echocardiographic data at the time of discharge and follow-up were obtained and analyzed. Primary aim of study is to analyze the hemodynamics of patients based on weight gain/loss. Secondary aim is to evaluate the same in patient-prosthesis mismatch (PPM) subgroup and to evaluate the study population for the potential to gain/loss weight. RESULTS: Among 118 patients, 87 patients (73.7%) gained weight. In 87 weight gained patients, left atrial (LA) size (p = 0.011) and pulmonary artery systolic (PA) pressure (p = 0.028) at follow-up were significantly elevated than the discharge values. Among 53 PPM patients (incidence, 44.9%), 34 patients gained weight and their PA pressure was found to be elevated at follow-up (p = 0.021) whereas weight lost group does not show any significant difference (p = 0.972). Frequency of weight gain was more among patients who weighed < 50 kg preoperatively (28 out of 30) (p = 0.013) and 20 to 30 years age group patients (p = 0.043). No sex predilection was noted (p = 0.149). CONCLUSION: In post-MVR patients, weight gain has definitive influence over hemodynamics. In PPM subgroup, weight gained patients had significantly increased PA systolic pressure at follow-up. Young, < 50 kg weighed, and PPM patients should be advised to maintain their weight post MVR for better hemodynamics.

Porcine versus bovine bioprosthetic valves in mitral position: does choice really matter?

BACKGROUND: Bioprosthetic valves are increasingly used for surgical mitral valve replacement (MVR). The long-term outcomes of bovine (BoMVR) vs porcine (PoMVR) remain an enigma regarding the durability. This study aims to examine the outcomes of BoMVR vs PoMVR. METHODS: A retrospective analysis of all bioprosthetic MVRs, with concomitant procedures, at a single tertiary referral institution from January 2005 to December 2008 was conducted. Procedures were classified as BoMVR or PoMVR. The age group was from 40 to 70 years. RESULTS: We identified 154 BoMVR patients and 120 PoMVR patients after matching the two groups with respect to age, sex, valve size and concomitant procedures. Kaplan-Meier survival analysis model was used for corresponding statistical analysis. Freedom from reoperation (all cause), freedom from non-structural valve deterioration, freedom from structural valve deterioration, freedom from heart failure and freedom from infective endocarditis were 96.4 ± 0.08, 97.1 ± 0.07, 96.4 ± 0.08%, 98.2 ± 0.07, and 98.6 ± 0.06% in PoMVR, respectively, and 92.6 ± 0.09, 91.6 ± 0.08, 90.6 ± 0.09, 94 ± 0.08, and 92.8 ± 0.08% in BoMVR groups, respectively, at the end of 10-year follow-up (mean follow up of 6.2 ± 2.3 years). Overall, 20 (12.9%) patients were lost to follow-up in the BoMVR and 15(12.5%) patients in the PoMVR groups for a global follow-up of 87.1%. CONCLUSIONS: For patients undergoing MVR with a bioprosthetic valve, the choice of PoMVR vs BoMVR favours more in favour of PoMVR as evidenced by the outcome results. Probably long-term follow-up with more patients might throw further light on the debatable topic.

Reversed Elephant Trunk Technique for the Repair of Type B Aortic Dissection: A Case Report.

We report a case of a type B aortic dissection with an aneurysm treated by the replacement of the proximal descending thoracic aorta via the reversed elephant trunk technique. A 48-year-old asymptomatic man was diagnosed with a type B aortic dissection, moderate aortic regurgitation, and a good biventricular function in March 2012. Four years later (April 2016), a contrast-enhanced computed tomography examination revealed an aneurysmal dilatation in the patient's descending thoracic aorta with a thrombosis in the proximal part of the false lumen, which warranted surgical repair. He underwent type B aortic dissection repair through the left posterolateral thoracotomy. Three months after the surgery, the patient developed a type A aortic dissection with severe aortic regurgitation, which was successfully managed via a Bentall procedure with arch replacement facilitated by the reversed elephant trunk technique performed during the initial surgery through thoracotomy. At 2 years follow-up, the patient was doing well with a normal left ventricular function.

Role of surgical ventricular restoration post surgical treatment of heart failure (STICH) trial.

OBJECTIVE: To compare the outcomes of isolated coronary artery bypass grafting (CABG) versus surgical ventricular restoration (SVR) with or without CABG for patients with ischemic cardiomyopathy (ICM). METHODS: Retrospectively, 49 patients with ICM and severe LV dysfunction (LVEF < 35%) who underwent SVR with or without CABG from January 2009 to December 2016 at a single institution was compared with 49 patients who underwent isolated CABG. The two groups were matched for preoperative clinical and echocardiographic parameters including left ventricular end-diastolic diameter (LVIDd), left ventricular end-systolic diameter (LVIDs), left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), and left ventricular end-systolic volume (LVESV). Primary outcomes analyzed included early mortality, late mortality, and major adverse cardiac or cerebrovascular events (MACCE). Secondary outcomes analyzed included echocardiographic parameters of left ventricular volume and function-indexed left ventricular end-diastolic volume (LVEDVi), indexed left ventricular end-systolic volume (LVESVi), and LVEF. Cox and survival analysis was performed. RESULTS: Early and late mortality in SVR vs. CABG groups were 4 (8.1%) and 6 (12.2%) vs. 1 (2%) and 5 (10.2%) respectively. Mean improvement in LVEF was 3.39 ± 7.51 compared to 4.97 ± 5.45 between the two groups at 3-month follow-up. Mean improvement in LVEF was 5.1 ± 8.3 in the SVR group vs 5.9 ± 7.1 in the CABG group at the last follow-up. There was no statistically significant improvement between the two groups in terms of LVEF at 3 months or the last follow-up. There were statistically significant differences between LVEDVi and LVESVi between the two groups at 3 months and the last follow-up. The 5-year rates of survival were 85 ± 6 and 82 ± 9% for SVR and CABG groups respectively. The 5-year rates of freedom from MACCE were 75 ± 7 and 60 ± 11% for SVR and CABG groups respectively. CONCLUSION: Compared with isolated CABG, SVR plus CABG results in equivalent late mortality and better left ventricular reverse remodeling (as evidenced by LV volume reduction) and better freedom from MACCE at 5-year follow-up.

Early hemodynamic performance of the Trifecta™ surgical bioprosthesis aortic valve in Indian patient population: 12 month outcomes of the EVEREST post-market study.

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.

Infected Teflon felt strip-paracardiac abscess after Dor's procedure.

Foreign material used for reconstructing or suturing the cardiac chambers carries the risk of infection. When such a scenario is encountered, it is better to be aggressive in removing the infected source surgically, as conservative management will most often result in recurrence. Herein, we present an unusual case of infected prosthetic material after cardiac surgery that was managed surgically. This case reminds us of the surgical principle of eradicating the source of infection, which should be given priority.

Repair of a Submitral Aneurysm with associated left atrial wall dissection.

We describe a case of submitral aneurysm in a 40-year-old man, which was distinctive in its anatomy and pathophysiology. The patient had a congenital submitral aneurysm located in the anterolateral part of the mitral annulus, complicated by dissection of the left atrial wall, severe mitral regurgitation, and compression of the left circumflex artery. He was managed successfully with aid of a comprehensive preoperative evaluation with all available imaging guidance and methodical surgical techniques, resulting in exclusion of the aneurysm, mitral valve replacement, and a graft to the left circumflex artery.

Pediatric heart transplant for unresectable primary cardiac tumor.

Surgery for primary cardiac tumors in children includes complete resection, partial resection, and cardiac transplantation. A pediatric heart transplant in this setting is associated with significantly higher mortality and poorer long-term outcome, and it is reserved for unresectable tumors. We recently performed an emergency pediatric heart transplant in a 7-year-old boy with an unresectable cardiac fibroma in the left ventricle.

Investigation of NKX2.5 gene mutations in congenital heart defects in an Indian population.

BACKGROUND AND AIM: Mutations in the NKX2.5 gene, a cardiac transcription factor, have been implicated in various types of congenital heart defects (CHD) and it is known that optimal expression levels of this gene are crucial for proper cardiogenesis. However, most of the mutations have been identified in cases of syndromic CHD, and the functional significance of other mutations in this gene has not been studied. We describe in this study the mutational and expression analysis of the NKX2.5 gene in nonsyndromic CHD patients. METHODS: In this study, exon 1 of the NKX2.5 gene was sequenced from 50 probands with sporadic CHD and 50 healthy volunteers. NKX2.5 gene expression levels in blood and cardiac tissue samples were analyzed by reverse transcriptase polymerase chain reaction (RT-PCR) in the probands. RESULTS: No new mutations were identified; however, a previously reported variant A63G (rs2277923) was found to be present at significantly higher levels in the CHD population than in the control group. Changes in expression between the blood and tissue samples were seen in 37 out of the 50 CHD patients. CONCLUSION: Multiple factors, in addition to NKX2.5 gene mutations, may cause CHDs. NKX2.5 gene mutations may be mosaic in nature, therefore warranting investigation in both blood and tissue samples.