Prospective clinical study of a novel left atrial appendage occlusion device.

PURPOSE: This Food and Drug Administration-approved investigational device exempt trial assessed the safety and efficacy of a novel device for external left atrial appendage (LAA) exclusion. DESCRIPTION: Delivery tool and implant consisting of connectors imbedded in a compliant, soft silicone applied to the base of the LAA flush with the external wall was assessed. EVALUATION: Patients in this prospective, multicenter trial were undergoing elective, nonendoscopic cardiac operations. A core laboratory independently assessed all intraprocedural and 90-day transesophageal echocardiograms. Sixty patients (37 men), aged 33 to 86 years, enrolled. The mean LAA application time was 27 seconds. Transesophageal echocardiograms at 90 days were available in 54 patients, and no leaks were detected. The residual LAA cavity exceeded 6 mm in 5 patients. One delivery device failed to close, and an adjunctive suture was required to complete LAA exclusion. One patient required adjunct sutures at a small tear site related to manual manipulation after fastener application. CONCLUSIONS: The study demonstrated safety and efficacy of this LAA exclusion device, offering an alternative to manual suturing or staples with or without reinforcement.

Antegrade versus retrograde cerebral protection in repair of acute ascending aortic dissection.

The objective of this study was to compare retrograde with antegrade cerebral protection during acute aortic dissection repair using cerebral oximetry measurements. Fifty consecutive acute ascending aortic dissection repairs were analyzed. Cerebral oximetry data were collected for 41 of 50. Eight patients who had antegrade cerebral protection alone and 29 of 41 had retrograde cerebral protection alone. The per cent change in cerebral oximetry values during deep hypothermic circulatory arrest from baseline and from prearrest values was compared for the two groups using Student t test. The per cent change from baseline for the antegrade patients was: right 13.8 per cent and left -2.5 per cent; the per cent change from baseline for retrograde patients was: right 0.8 per cent and left 0.2 per cent (P values 0.216 and 0.725, respectively). The per cent change from the prearrest value for the antegrade patients was: right -12 per cent and left -15 per cent; the per cent change from prearrest for retrograde patients was: right -15 per cent and left -16 per cent (P values 0.514 and 0.956, respectively). No compelling evidence for an advantage to either antegrade or retrograde cerebral perfusion was detected. Further study with a focus on neurologic outcomes is warranted.

Inflammatory aneurysms of the ascending aorta: diagnosis and surgical treatment.

Inflammatory aortic aneurysms (IAAs) are rare and located mainly in the infra-renal abdominal aorta. The ascending aorta has been typically spared from this process. We report on two cases of ascending aortic inflammatory aneurysms and describe the available literature on this rare entity.

Proximal thoracic aortic replacement for aneurysmal disease using the freestyle stentless bioprosthesis: a 10-year experience.

BACKGROUND: Porcine bioprosthesis (bioroots) are an attractive surgical strategy for ascending aorta and arch replacement. This study evaluated the perioperative and late outcomes using this strategy for proximal aortic aneurysmal disease. METHODS: Between March 1998 and November 2009, 170 patients (40% women; median age, 70 years) underwent proximal thoracic aortic replacement using the Freestyle (Medtronics Inc, Minneapolis, MN) bioroot, with graft extension in 149 (87.6%). Aneurysmal etiology included degenerative-atherosclerotic (91.2%), acute dissection (5.3%), and chronic dissection (3.5%); 78% had greater than moderate aortic insufficiency. Surgical procedures were bioroot alone or with aortoplasty (12.3%), bioroot with ascending aortic graft (38.2%), bioroot with hemiarch graft (44.1%), and bioroot with total arch (5.3%). Hypothermic circulatory arrest was required in 49%. RESULTS: The 30-day mortality was 4.7% (n=8). The overall complication rate was 58% (n=100), including stroke (6.5%), renal failure (9.2%), respiratory failure (25.9%), and postoperative bleeding (7.6%). Mean hospitalization was 10.5±7.3 days; 38 were discharged to a rehabilitation facility (23.5%). Predictors of 30-day/hospital death were coronary artery disease (p=0.0003), renal insufficiency (p<0.0001), emergent/urgent procedure (p=0.02), and hypothermic circulatory arrest (p=0.002). The 1-year, 5-year, and 10-year survivals were 90%, 80%, and 35% respectively. Freedom from endocarditis and reoperation was 96% at 1 year and 94% and 95% at 5 years, respectively. CONCLUSIONS: Proximal thoracic aortic replacement using a porcine bioroot as part of the repair can be achieved with low perioperative mortality and acceptable late survival in a predominantly elderly population.

Thoracic aortic mobile thrombus: is there a role for early surgical intervention?

BACKGROUND: The diagnosis of thoracic aortic mobile thrombus (TAMT) is rare and is usually made after debilitating embolic events. The optimal treatment strategy is unknown. We report 14 patients with TAMT and aim to better define the role of early (less than 2 weeks) surgical thrombectomy. METHODS: Between February 1996 and February 2010, we treated 14 patients (9 women; aged 32 to 84 years, mean age 51 years) with TAMT. Hypercoagulable disorders or a strong family history of vascular thrombosis, or both, occurred in 9 patients. Diagnosis was made by transesophageal echocardiogram in 6, computed tomography angiography in 7, and digital subtraction angiography in 1. Embolic locations were extremities (n=9), cerebral (n=6), and abdominal (n=6). Aortic thrombi (n=17) locations were ascending/arch (n=7), descending (n=8), and thoracoabdominal (n=2). RESULTS: All patients were initially treated with heparin and aspirin. Thoracic aortic thrombectomies were performed in 8 patients within 2 weeks of diagnosis: left thoracotomy (n=5), thoracoabdominal (n=1), and median sternotomy (n=2). Left atrial-femoral bypass was used in 5 patients, cardiopulmonary bypass in 2, and no support in 1. Additional procedures were celiac artery (n=1) and left subclavian artery (n=2) thrombectomies. Procedures for embolic complications were performed in 7 patients before aortic thrombectomy. Operative mortality was 0%, with no recurrent embolic events after 24±16 months. One patient had thrombectomy of the ascending aorta and medical therapy with warfarin and aspirin for a second concurrent small thrombus in the descending aorta. One patient presented with multiorgan failure and died shortly after admission. Six patients treated medically were discharged on a regimen of oral warfarin and aspirin (14±11 months follow-up), with 2 fatal recurrent embolic events within 6 weeks (p=0.09). CONCLUSIONS: Thoracic aortic mobile thrombus is rare and is commonly associated with morbid thromboembolic events. In our experience, early surgical aortic thrombectomy had a low operative risk and may prevent fatal recurrent embolic events.

Band occlusion of the atrial appendage.

OBJECTIVES: A new device has been developed for occlusion of the left atrial appendage (LAA). Previous investigations have been in the canine model. The canine atrial appendage does not vary in size and shape as much as the human. The goal of this study was to investigate band occlusion of right atrial appendages in the pig model, which are more broad based. METHODS: The right atrial appendages of six pigs were approached through a right thoracotomy. An expandable polyester fabric-covered silicone band was placed on the appendage. The animals were evaluated at the time of band placement with fluoroscopy, contrast injection, and in three animals, echocardiography. After one week, the animals were again evaluated with fluoroscopy. The animals were sacrificed at 12 weeks. RESULTS: Bands were placed without complication at the base of all six appendages. All appendages were effectively occluded and all bands remained at the appendage base. The healed atrial surface was consistently smooth and devoid of thrombus. CONCLUSIONS: Occlusion of a broad-based appendage as seen with human LAA is feasible with this novel band technique.

Repair of mitral valve and left atrioventricular disruption caused by blunt chest trauma.

We describe a case of acute cardiac failure in a patient involved in a motor vehicle accident. A diagnosis of acute mitral regurgitation and left atrioventricular disruption was made with transesophageal echocardiography. Successful repair was performed using the mitral valve leaflets to patch the disruption followed by valve replacement.