A modified "preclosure" technique after percutaneous aortic valve replacement.
ABSTRACT To evaluate the feasibility, safety and efficacy of suture-mediated closure devices using a modified "preclosure" technique for access site management after percutaneous aortic valve replacement (PAVR).
PAVR using a retrograde transfemoral approach has recently evolved to an endovascular alternative to open surgery in high-risk patients. However, large-bore femoral artery access is required, commonly demanding surgical closure and general anesthesia. A truly percutaneous intervention would be desirable to reduce procedural complexity and diminish the need of vascular surgery and general anaesthesia.
After direct puncture of the common femoral artery, three conventional suture-mediated closure devices (6F Perclose) were deployed. The preloaded sutures were tied at the end of the procedure. If no immediate hemostasis was achieved, an additional device was deployed thereafter.
PAVR with percutaneous access site closure was attempted in 15 consecutive patients and could successfully be achieved in all patients allowing conscious sedation in all but three cases. Following complications occurred: one retroperitoneal bleeding caused by removal of the valve delivery sheath requiring surgical repair, as well as two cases of femoral and iliac artery dissection caused by delivery sheath introduction and treated by stenting and vascular surgery, respectively. Vascular surgery became only necessary due to total vessel occlusion after suture closure and remains the only closure-related complication. However, treatment led to recovery in all patients.
The modified "preclosure" technique is a feasible and safe method for hemostasis after PAVR improving procedural management and diminishing the need for general anesthesia.
- SourceAvailable from: Anna T R Legedza[show abstract] [hide abstract]
ABSTRACT: Aortic stenosis (AS) remains the most common valvular disease of the elderly in the United States. Though valve replacement has proven effective among older adults, decision-making regarding surgery is difficult for these patients and their physicians. Herein, the clinical outcomes and decision-making process for elderly patients with severe symptomatic AS was assessed. A retrospective cohort study of patients aged > or = 60 years with severe AS was conducted at two large urban teaching hospitals. Severe AS was defined by a mean valve gradient > or = 50 mmHg or valve area < 0.8 cm2 by echocardiogram, and associated symptoms (angina, congestive heart failure, dyspnea, fatigue, or exercise intolerance). Demographic and clinical data and information about decision-making were obtained from inpatient and outpatient medical records. Of the 124 patients studied, 49 (39.5%) had aortic valve replacement (AVR) surgery. In a logistic regression analysis adjusting for gender, comorbidity and baseline functional status, those patients aged < 80 years were significantly more likely to have surgery than older patients. Surgery was associated with a large reduction in mortality in all age groups. At one-year follow up, 87.8% of all patients (87.5% of those aged > or = 80 years) who had undergone surgery were alive, while only 54.7% (49.1% of those aged > or = 80 years) who did not receive surgery were alive. Postoperative complications were similar among older and younger elderly patients. Comorbidity and age were the most common reasons for not offering elderly patients valve replacement. The results of the present study showed that AVR surgery improves the survival of elderly patients with severe AS, and patients aged > 80 years experience benefits similar to younger patients. Nevertheless, these findings suggest that surgery may not always be offered to elderly patients who might benefit from it.The Journal of heart valve disease 05/2006; 15(3):312-21. · 1.07 Impact Factor
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ABSTRACT: The objective of this study was to assess the early safety and efficacy of the novel 6 Fr Angio-Seal device for routine clinical use after diagnostic cardiac catheterization and coronary angioplasty. In a prospective study, we used the 6 Fr Angio-Seal device in 180 consecutive patients (131 male, 49 female, mean age 60.7 years) for closure of femoral arterial puncture sites immediately after diagnostic (n = 108) or interventional (n = 72) coronary procedures independent of the coagulation status. All patients were monitored for 24 hr after the procedure and followed for 30 days. The closure device was successfully deployed in 95.4% after diagnostic catheterization versus 98.6% after coronary angioplasty (P = 0.963). Immediate hemostasis was achieved in 91.5% versus 90.1% of the patients (P = 0.993). Major complications were observed 1.9% versus 2.8% of the patients (P = 0.885). During 30-day follow-up, no late events or complications were reported. The 6 Fr Angio-Seal device is a safe and effective device that allows for immediate closure of femoral puncture sites after both diagnostic and interventional procedures with a low rate of major complications.Catheterization and Cardiovascular Interventions 09/2001; 53(4):437-42. · 2.51 Impact Factor
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ABSTRACT: Percutaneous balloon aortic valvuloplasty has been used as a therapeutic option for patients with severe aortic stenosis who are not candidates for aortic valve replacement. This procedure has been limited by both the high rate of aortic valve restenosis and high procedural morbidity related chiefly to the large femoral arteriotomies required. The purpose of this study was to assess the feasibility and vascular complication rate using the "Preclose" technique in patients undergoing balloon aortic valvuloplasty. We evaluated the immediate and 30-day results in 18 consecutive patients undergoing this procedure. Angiographically significant peripheral vascular disease was present in 39% of cases. Aortic balloon dilation produced significant decreases in the mean aortic valve pressure gradient from 55 +/- 20 mmHg to 30 +/- 22 mmHg (P < 0.001). Closure of the arteriotomy with an 8F (10F in 1 case) Perclose device led to immediate hemostasis in all patients. Perclose of the contralateral femoral arterial site with a 6F device was attempted in 50%, all of which were successful. The mean length of bed rest was 4.5 +/- 0.9 hr. No procedural was observed. No patient had a local vascular complication, and no patient required blood product transfusion after the procedure. The use of the "Preclose" technique for closure of femoral arteriotomies after balloon aortic valvuloplasty is feasible and associated with a low rate of periprocedural and short-term vascular complications.Catheterization and Cardiovascular Interventions 09/2001; 53(4):445-7. · 2.51 Impact Factor