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.

Post myocardial infarction ventricular septal rupture-protracted hemolysis due to missed additional ventricular septal defect.

Hemolysis is a known and usually self-limiting complication of transcatheter device closure of post-myocardial infarction ventricular septal rupture (VSR). Multiple defects, serpiginous pathways, friable margins, left ventricular aneurysms, and improper size of the device have been described as causes for persistent residual shunt across the device. We report a case of protracted hemolysis after device closure of VSR requiring surgical intervention. During device retrieval and patch closure, a muscular band was observed dividing the VSR into two, allowing residual shunt across the second defect. Supplementary Information: The online version contains supplementary material available at 10.1007/s12055-022-01470-8.

Successful surgical management of a congenital giant right atrial appendage aneurysm: a case report on a rare cardiac anomaly.

Aneurysms of the right atrial appendage are usually congenital in origin, with rare citations. We report a case of a large atrial aneurysm in an adult male presenting with atrial flutter and right ventricular dysfunction, who underwent a successful aneurysmectomy, repaired with a novel technique with uneventful recovery.

Management of infected recurrent mediastinal bronchogenic cyst with tuberculous mediastinal lymphadenitis.

We describe a case of a 20-year-old woman with recurrent bronchogenic cyst. The cyst made its debut at the age of six, which was excised surgically. Preoperative investigations revealed a mass in the right parasternal region extending from around the pericardium, present between the second and fourth ribs and abutting the right mediastinal structures. Dense adhesions were noted and released selectively to avoid iatrogenic injury. Complete evacuation and excision of the cyst from around the pericardium and phrenic nerve with marsupialization of the sac were performed. The patient's post-operative course was uneventful.

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.