High Surgical Risk Patients (high + surgical_risk_patient)

Distribution by Scientific Domains

Selected Abstracts

Percutaneous Closure of Postmyocardial Infarction Ventricular Septal Defect

Postinfarction ventricular septal defect remains an important complication for myocardial infarction. It is associated with high mortality and morbidity. Despite early surgical closure attempts, mortality remains about 19,49%. Percutaneous approach, especially in high surgical risk patients is a promising alternative to traditional surgical closure, thus avoiding the deleterious effects of cardiopulmonary bypass and the ventriculotomy. The Amplatzer P.I. Ventricular Septal Defect Occluder is a device specifically designed to percutaneously close these defects in adult patients. The results reported using this device are comparable (if not better) to those for surgical closure. Here, we review the experience using this device and depict in detail the technical aspects of the procedure. [source]

Results of percutaneous transhepatic cholecystostomy for high surgical risk patients with acute cholecystitis

Kenneth S. H. Chok
Abstract Aim:, To assess the efficacy and safety of percutaneous transhepatic cholecystostomy (PTC) in treatment for acute cholecystitis in high surgical risk patients. Patients and methods:, A retrospective review was carried out from January 1999 to June 2007 on 23 patients, 11 males and 12 females, who underwent PTC for the management of acute cholecystitis at the Department of Surgery, Queen Mary Hospital, Hong Kong, China. The mean age of the patients was 83. They all had either clinical or radiological evidence of acute cholecystitis and had significant pre-morbid diseases. The median follow-up period on them was 35 months. Results:, All the PTCs performed were technically successful. One patient died from procedure-related haemoperitoneum, while 87% (n= 20) of all the patients had clinical resolution of sepsis by 20 h after PTC. Eight patients underwent elective cholecystectomy afterwards (62.5% with the laparoscopic approach). Eight patients had dislodgement of the PTC catheter and one of them developed recurrent acute cholecystitis 3 months after PTC. That patient was treated conservatively. Four patients died from their pre-morbid conditions during the follow-up period. Conclusion:, PTC was a safe and effective alternative for treating acute cholecystitis in this group of patients. Thirteen of them without elective cholecystectomy performed did not have recurrent acute cholecystitis after a single session of PTC. It may be considered as a definitive treatment for this group of patients. [source]

Safety and effectiveness of the INVATEC MO.MA® proximal cerebral protection device during carotid artery stenting: Results from the ARMOUR pivotal trial,

Gary M. Ansel MD
Abstract Objective: The multicenter ARMOUR (ProximAl PRotection with the MO.MA Device DUring CaRotid Stenting) trial evaluated the 30-day safety and effectiveness of the MO.MA® Proximal Cerebral Protection Device (Invatec, Roncadelle, Italy) utilized to treat high surgical risk patients undergoing carotid artery stenting (CAS). Background: Distal embolic protection devices (EPD) have been traditionally utilized during CAS. The MO.MA device acts as a balloon occlusion "endovascular clamping" system to achieve cerebral protection prior to crossing the carotid stenosis. Methods: This prospective registry enrolled 262 subjects, 37 roll-in and 225 pivotal subjects evaluated with intention to treat (ITT) from September 2007 to February 2009. Subjects underwent CAS using the MO.MA device. The primary endpoint, myocardial infarction, stroke, or death through 30 days (30-day major adverse cardiac and cerebrovascular events [MACCE]) was compared to a performance goal of 13% derived from trials utilizing distal EPD. Results: For the ITT population, the mean age was 74.7 years with 66.7% of the cohort being male. Symptomatic patients comprised 15.1% and 28.9% were octogenarians. Device success was 98.2% and procedural success was 93.2%. The 30-day MACCE rate was 2.7% [95% CI (1.0,5.8%)] with a 30-day major stroke rate of 0.9%. No symptomatic patient suffered a stroke during this trial. Conclusions: The ARMOUR trial demonstrated that the MO.MA® Proximal Cerebral Protection Device is safe and effective for high surgical risk patients undergoing CAS. The absence of stroke in symptomatic patients is the lowest rate reported in any independently adjudicated prospective multicenter registry trial to date. © 2010 Wiley-Liss, Inc. [source]

Carotid artery stenting in high surgical risk patients using the FiberNet® embolic protection system: The EPIC trial results,

FACC, Subbarao Myla MD
Abstract Objective: The multicenter EPIC (FiberNet Embolic Protection System in Carotid Artery Stenting Trial) single-arm trial evaluated the 30-day outcomes of a new design concept for embolic protection during carotid artery stenting (CAS). Background: Embolic protection filters available for use during CAS include fixed and over-the-wire systems that rely on embolic material capture within a "basket" structure. The FiberNet® Embolic Protection System (EPS), which features a very low crossing profile, consists of a three-dimensional fiber-based filter distally mounted on a 0.014 inch guidewire with integrated aspiration during filter retrieval. Methods: The trial enrolled 237 patients from 26 centers. Demographics, clinical and lesion characteristics, as well as adverse events through a 30-day follow-up were recorded. The mean age of the patients was 74 years, 64% were male and 20% had symptomatic carotid artery disease. Results: The combined major adverse event (MAE) rate at 30 days for all death, stroke, and myocardial infarction was 3.0%. There were three major strokes (two ischemic and one hemorrhagic) and two minor strokes (both ischemic) for a 2.1% 30-day stroke rate. The procedural technical success rate was 97.5% and macroscopic evidence of debris was reported in 90.9% of the procedures. Conclusions: The FiberNet EPS, used with commercially available stents, produced low stroke rates following CAS in high surgical risk patients presenting with carotid artery disease. The unique filter design including aspiration during retrieval may have contributed to the low 30-day stroke rate reported during CAS in patients considered at high risk for complications following carotid endarterectomy (CEA). © 2009 Wiley-Liss, Inc. [source]

Carotid artery revascularization in high surgical risk patients with the NexStent and the Filterwire EX/EZ

1-Year results in the CABERNET trial
Abstract Objective: The multicenter, single-arm CABERNET trial evaluated outcomes in high-surgical-risk patients with carotid artery stenosis treated with the NexStent® plus FilterWire EX®/EZÔ Emboli Protection System. Background: For patients at high surgical risk, carotid artery stenting (CAS) offers a less invasive alternative to carotid endarterectomy (CEA). Methods: The trial enrolled 454 high-surgical-risk patients with carotid stenosis by angiography ,50% for symptomatic patients and ,60% for asymptomatic patients. The comparator primary endpoint was the 1-year major adverse event (MAE, defined as any death, stroke, or myocardial infarction [MI]) rate. It was compared with a proportionally weighted objective performance criterion (OPC) of 12.1% representative of published CEA results in similar patients plus a prespecified noninferiority margin (delta) of 4%. A second primary endpoint was the composite rate of 30-day MAE plus late (31,365 days) ipsilateral stroke. Results: Symptoms of carotid stenosis were present in 24.2% of patients; 36.6% of patients were considered high-surgical-risk due to comorbid risk factors and 63.4% due to anatomic risk factors. The rate of 30-day MAE plus late ipsilateral stroke was 4.7% (20/438). The comparator primary endpoint of 1-year MAE was 11.6% (51/438) and was noninferior to the OPC of 12.1% (95% upper confidence interval of 14.5% versus OPC plus delta of 16.1%, P = 0.005). Late ipsilateral stroke was 0.7% and target vessel revascularization at 1 year was 2.4%. Conclusions: The CABERNET trial demonstrates that CAS with NexStent and FilterWire is noninferior to (equivalent or better than) traditional CEA at 1 year in high-surgical-risk patients based on historical controls. © 2008 Wiley-Liss, Inc. [source]