Carpentier-Edwards PERIMOUNT Magna bioprosthesis: A stented valve with stentless performance?

ObjectiveWe designed this study to evaluate the early hemodynamic performance of the recently introduced Carpentier-Edwards PERIMOUNT Magna bioprosthesis (Edwards Lifesciences, Irvine, Calif) and compare it with those of the conventional Carpentier-Edwards PERIMOUNT stented bioprosthesis (Edwards Lifesciences) and Edwards Prima Plus porcine stentless bioprosthesis (Edwards Lifesciences).MethodsSixty-three patients (>70 years old) were enrolled in this prospective, randomized study. At operation, once the annulus had been measured, the best size suitable was assessed for each of the three valves before random assignment. Transthoracic echocardiography was performed before discharge to evaluate early postoperative hemodynamic performances of the different valves implanted.ResultsThe best size suitable of Edwards Prima Plus (24.3 ± 1.7 mm) was significantly superior to those of both the Carpentier-Edwards PERIMOUNT Magna (23.4 ± 2.1 mm) and Carpentier-Edwards PERIMOUNT (22.4 ± 1.8 mm). The best size suitable of the Carpentier-Edwards PERIMOUNT Magna, however, was significantly superior to that of the Carpentier-Edwards PERIMOUNT. Furthermore the best size suitable of the Carpentier-Edwards PERIMOUNT Magna was equal to the measured annulus in 55% of patients, as opposed to 25% for the Carpentier-Edwards PERIMOUNT (P < .001). Mean implanted labeled size of the Edwards Prima Plus was significantly higher than those of both the Carpentier-Edwards PERIMOUNT Magna and the Carpentier-Edwards PERIMOUNT (24.6 ± 1.9 mm, 23.1 ± 1.9 mm, and 22.5 ± 1.8 mm, respectively). Early postoperative hemodynamic performance of the Carpentier-Edwards PERIMOUNT Magna, however, was superior to those of both the Edwards Prima Plus and the Carpentier-Edwards PERIMOUNT in both effective orifice area index (1.07 ± 0.4 cm2/m2, 0.87 ± 0.3 cm2/m2, and 0.80 ± 0.2 cm2/m2, respectively) and mean peak gradient (20 ± 6 mm Hg, 27 ± 8 mm Hg, and 28 ± 12 mm Hg, respectively).ConclusionThe improved design of the recently introduced third-generation stented bioprosthesis Carpentier-Edwards PERIMOUNT Magna allows implantation of a significantly bigger valve than with the old generation. Furthermore, the improved hemodynamic performance of the Carpentier-Edwards PERIMOUNT Magna compares favorably with both the Carpentier-Edwards PERIMOUNT and the Edwards Prima Plus

Emergency thoracotomy for thoracic trauma in the accident and emergency department: indications and outcome

To assess the efficacy of emergency thoracotomy performed for thoracic trauma in the accident and emergency department, a retrospective analysis of patients who underwent this procedure and were brought to hospital by the Helicopter Emergency Medical Service was carried out. Between 1991 and 1994, 16 patients had emergency thoracotomy performed in the accident department. Twelve patients had sustained blunt trauma and four patients had sustained penetrating injuries. Three patients first assessed at the scene and 11 patients on arrival at the emergency department had Glasgow Coma Scores <3. Eight thoracotomies were performed by the cardiothoracic team and eight by the trauma team. There was one survivor in this group; he had been stabbed at multiple sites and emergency thoracotomy was required to control bleeding from an intercostal vessel. Our results demonstrate experience of one of the first phase Level One trauma centres in the United Kingdom. From our small series, we believe that selection criteria for emergency thoracotomy in trauma patients need to be revised. From this series and a review of the literature, patients with penetrating injuries, vital signs at the scene and those with a high index of suspicion for tamponade seem to benefit most from thoracotomy in the emergency setting

Effect of transcatheter aortic valve implantation vs surgical aortic valve replacement on all-cause mortality in patients with aortic stenosis

Importance: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement and is the treatment of choice for patients at high operative risk. The role of TAVI in patients at lower risk is unclear. Objective: To determine whether TAVI is noninferior to surgery in patients at moderately increased operative risk. Design, Setting, and Participants: In this randomized clinical trial conducted at 34 UK centers, 913 patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014 and April 2018 and followed up through April 2019. Interventions: TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgical aortic valve replacement (surgery; n = 455). Main Outcomes and Measures: The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the 1-sided 97.5% CI for the absolute between-group difference in mortality. There were 36 secondary outcomes (30 reported herein), including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation. Results: Among 913 patients randomized (median age, 81 years [IQR, 78 to 84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0% to 3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of −2.0% (1-sided 97.5% CI, −∞ to 1.2%; P &lt; .001 for noninferiority). Of 30 prespecified secondary outcomes reported herein, 24 showed no significant difference at 1 year. TAVI was associated with significantly shorter postprocedural hospitalization (median of 3 days [IQR, 2 to 5 days] vs 8 days [IQR, 6 to 13 days] in the surgery group). At 1 year, there were significantly fewer major bleeding events after TAVI compared with surgery (7.2% vs 20.2%, respectively; adjusted hazard ratio [HR], 0.33 [95% CI, 0.24 to 0.45]) but significantly more vascular complications (10.3% vs 2.4%; adjusted HR, 4.42 [95% CI, 2.54 to 7.71]), conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%; adjusted HR, 2.05 [95% CI, 1.43 to 2.94]), and mild (38.3% vs 11.7%) or moderate (2.3% vs 0.6%) aortic regurgitation (adjusted odds ratio for mild, moderate, or severe [no instance of severe reported] aortic regurgitation combined vs none, 4.89 [95% CI, 3.08 to 7.75]). Conclusions and Relevance: Among patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery with respect to all-cause mortality at 1 year. Trial Registration: isrctn.com Identifier: ISRCTN57819173