Incidence Of Procedure-related Complications Research Articles

Perioperative Morbidity and Mortality After Anterior, Posterior, and Anterior/Posterior Spine Fusion Surgery

Analysis of population-based national hospital discharge data collected for the National Inpatient Sample. To examine demographics of patients undergoing primary anterior spine fusion (ASF), posterior spine fusion (PSF), and anterior/posterior spine fusion (APSF) of the noncervical spine, assess the incidence of perioperative morbidity and mortality, and determine independent risk factors for in-hospital death. The utilization of surgical fusion has been increasing dramatically. Despite this trend, a paucity of literature addressing perioperative outcomes exists. Data collected for each year between 1998 and 2006 for the National Inpatient Sample were analyzed. Discharges with a procedure code for primary noncervical spine fusion were included in the sample. The prevalence of patient as well as health care system-related demographics were evaluated by procedure type (ASF, PSF, and APSF). Frequencies of procedure-related complications and in-hospital mortality were analyzed. Independent predictors for in-hospital mortality were determined. We identified 261,256 entries representing an estimated 1,273,228 hospitalizations for primary spine fusion. Patients undergoing ASF and APSF were significantly younger (44.8 ± 0.08 and 44.22 ± 0.11 years) and had lower average comorbidity indeces (0.30 ± 0.002 and 0.31 ± 0.004) than those undergoing PSF (52.12 ± 0.04 years and 0.41 ± 0.002) (P < 0.0001). The incidence of procedure-related complications was 18.68% among ASF, 15.72% in PSF, and 23.81% in APSF patients (P < 0.0001). In-hospital mortality rates after APSF were approximately twice those of PSF (0.51 ± 0.038 vs. 0.26 ± 0.012) (P < 0.0001). Adjusted risk factors for in-hospital mortality included the following: APSF and ASF compared to PSF, male gender, increasing age, and increasing comorbidity burden. Several comorbidities and complications independently increased the risk for perioperative death, as did underlying spinal pathology. Despite being performed in generally younger and healthier patients, APSF and ASF are associated with increased morbidity and mortality. Our findings can be used for the purposes of risk stratification, accurate patient consultation, and hypothesis formation for future research.

Comparative in-hospital morbidity and mortality after revision versus primary thoracic and lumbar spine fusion

Background context Despite increasing utilization of surgical spine fusions, a paucity of literature addressing perioperative complications after revision posterior spinal fusion (RPSF) versus primary posterior spine fusion (PPSF) of the thoracic and lumbar spine exists. Purpose To examine demographics of patients undergoing PPSF and RPSF of the thoracic and lumbar spine, assess the incidence of perioperative morbidity and mortality, and determine independent risk factors for in-hospital death. Study design/setting Analysis of nationally representative data collected for the National Inpatient Sample (NIS). Patient sample All discharges included in the NIS with a procedure code for posterior thoracic and lumbar spine fusion from 1998 to 2006. Outcome measures In-hospital mortality and morbidity. Methods Data collected for each year between 1998 and 2006 for the NIS were analyzed. Discharges with a procedure code for thoracic and lumbar spine fusion were included in the sample. The prevalence of patient- as well as health care–related demographics was evaluated by procedure type (primary vs. revision). Frequencies of procedure-related complications and in-hospital mortality were analyzed. Independent predictors for in-hospital mortality were determined. Results We identified 222,549 PPSF and 12,474 RPSF discharges between 1998 and 2006. Patients undergoing PPSF were significantly younger (51.23 years; confidence interval [CI]=51.16, 51.31) and had lower average comorbidity indices (0.40; CI=0.39, 0.41) than those undergoing RPSF (52.69 years; CI=52.43, 52.97) and (0.44; CI=0.43, 0.45), p<.0001. The incidence of procedure-related complications was 16.02% among RPSF compared with 13.44% in PPSF patients (p<.0001). In-hospital mortality rates after PPSF were approximately twice those of RPSF (0.28% vs. 0.15%, p=.006). Adjusted risk factors for increased in-hospital mortality included PPSF compared with RPSF, male gender, and increasing age. A number of comorbidities, complications, and specific surgical indications increased the risk for perioperative death. Conclusion Despite being performed in generally younger and healthier patients and having lower perioperative morbidity, PPSF procedures are associated with increased mortality compared with RPSF procedures. The findings of this study can be used for risk stratification, accurate patient consultation, and hypothesis formation for future research.

Percutaneous Vascular Cannulation for Extracorporeal Life Support (ECLS): A Modified Technique

Vascular access and cannulation are crucial issues to maximize the efficiency of extracorporeal circulation techniques and to preserve patients' safety. Techniques of cannulation have changed over the years, from surgical cutdown to percutaneous approaches, which are now considered standard practice. We describe an original modified percutaneous cannulation technique developed in our Department and we report our clinical experience and complications observed. A Seldinger technique utilizing 3 guidewires with passage of a dilator over each guidewire was used. Two concentric pursestring sutures, prepared before cannulation, minimize procedure-associated bleeding. Cannulation is performed under direct fluoroscopic control. From 1997 to 2009, 38 patients (31 VV-ECLS, 7 VA-ECLS) have been cannulated using our technique, resulting in a total of 69 venous cannulations. Average external caliber of venous cannulae was 23 Fr (15-29 Fr). Mean duration of the entire cannulation procedure was 40 minutes (20-60 min). Adverse events occurred in 3 patients. The technique described is safe and feasible and the incidence of procedure-related complications is very low, but it may require longer time to be performed.

PP-003 Endoscopic retrograde cholangiopancreatography in renal patients: a case control study of complication rates

<h3>Introduction</h3> Endoscopic retrograde cholangiopancreatography (ERCP) remains a high-risk procedure with a significant incidence of procedure related complications. Endoscopy in patients with renal disease has additional associated morbidity. The aim of the study was to determine the incidence of procedure related complications following ERCP in a cohort of patients with end stage renal disease receiving dialysis (ESRD) and renal transplant recipients (RT). <h3>Methods</h3> A retrospective analysis of patients under the care of the largest renal unit in Europe, who underwent ERCP during a 36-month period. A cohort of patients without renal disease, matched for age, sex, comorbidities, indication, procedural intervention and results were used for comparison. <h3>Results</h3> 51 ERCPs were performed on ESRD and RT patients, and 100 case control matched ERCPs were randomly selected retrospectively over the study period. 35 ERCPs were performed on ESRD patients (median age 66.7, M/F ratio 1.9:1). Sphincterotomies were performed in 65.7% (23/35) of procedures. There was a significant increased risk of post-sphincterotomy bleeding in the ERSD group vs the control group (6/23 vs 2/56, p&lt;0.01) and a significant increased risk of post ERCP pancreatitis (9/35 vs 9/100, p&lt;0.05). 16 ERCPs were performed on RT patients (median age 64.5; M/F ratio 1.3:1). Sphincterotomies were performed in 50.0% (8/16) of procedures. There was a significant increase in the risk of post sphincterotomy bleeding in the RT group vs the control group (3/8 vs 2/56, p&lt;0.05) and a significant increased risk of post ERCP pancreatitis (5/15 vs 9/100, p&lt;0.05). No patient related factors were related to the incidence of post ERCP pancreatitis in ESRD nor RT patients, and the absence of a sphincterotomy was the only procedural related factor significantly related to the incidence of post ERCP pancreatitis in either group (OR 1.46, 95% CI 1.06 to 2.00). ERSD patients had a significant increase in 30-day procedural related morbidity vs control group (17/35 vs 17/100, p&lt;0.001, OR 4.05, 95% CI 1.74 to 9.46). There was no significant increase in 30-day procedure related morbidity in RT patients vs the control group. No significant increase in 30-day mortality was demonstrated between the ESRD nor the RT group and the control group. <h3>Conclusion</h3> ERCP in both ESRD and RT patients is a high-risk procedure with a significant added incidence of post ERCP pancreatitis and post sphincterotomy bleeding. These findings suggest that ERCP and sphincterotomy should be approached with caution in this select group of patients, and measures targeted to minimise the risk of these complications should be employed.

S1437: Incidence Rates of Post-ERCP Complications: A Case Control Study in Renal Transplant Recipients and Dialysis Patients

Endoscopic retrograde cholangiopancreatography (ERCP) remains a high risk procedure with a significant incidence of procedure related complications. Endoscopy in patients with renal disease has additional associated morbidity.

The Importance of Ureteral Stenting in Major Debulking Surgery

vic peritonectomy and bilateral lymphadenectomy of internal and external iliac and obturatory lymph nodes were performed. In patients with gynecologic cancer, aortic and caval lymph nodes until the origin of the gonadic vessels were removed. The interventions were performed with the removal of the peritoneum of interest on the abdominal wall, on diaphragms, and on the visceral and mesenteric surfaces. Appendectomy and cholecystectomy were always performed to prevent hyperthermic chemotherapyY induced ischemia. In some cases, intestinal resection, splenectomy, and partial hepatectomy were required. Ureters were completely mobilized in all procedures. In 4 patients, because of the extremely compromised pelvic condition, pelvic exenteration was necessary, and a cutaneous ureterostomy was made. At the end of the exenteration phase, a hyperthermic chemoperfusion was performed for 90 minutes. The trial protocol schedules the positioning of bilateral ureteral stents (JJ stent; Vortek, Porges, France) before the surgical procedure. Stents are positioned by the urologist cystoscopically with 1-shot antibiotic prophylaxis and have to be removed 21 days after the intervention. No major complications were observed immediately after the procedure. The only minor complication observed was self-limiting hematuria. Moreover, a broad-spectrum antibiotic therapy is started immediately before the intervention and continued for 21 days after the operation. We agree with the authors on the necessity of a more exhaustive literature concerning the use of prophylactic ureteral stenting for such aggressive surgical procedures. For this reason, we believe that it could be appreciable to present our results. From 2007 until today, we enrolled 33 patients; all presented with disseminated intraperitoneal cancer: 19 patients (67.8%) with ovarian cancer, 5 (17.8%) with colorectal cancer, 4 (14.8%) with peritoneal mesothelioma, 1 (3.5%) with pseudomyxoma peritonei, 1 (3.5%) with appendiceal cancer, 1 (3.5%) with cancer of the cardia, and 2 (7.1%) with uterine cancer. In all patients, ureteral stents were placed. Twenty-eight (84.8%) of 33 patients have been referred to peritonectomy with HIPEC. Ureteral stenting was managed according to the rules explained previously. None of the patients incurred major ureteral complications or urinary tract infections postoperatively. We think that, and also according to Ang and Naik, prophylactic ureteral stenting before major debulking surgical procedures reduces the risk of postoperative ureteral complications. Moreover, it is an easy and safe maneuver with a very low incidence of procedurerelated complications.

Magnetstyrt ablasjonsbehandling av hjerterytmeforstyrrelser

The first use of magnetic navigation for radiofrequency ablation of supraventricular tachycardias, was published in 2004. Subsequently, the method has been used for treatment of most types of tachyarrhythmias. This paper provides an overview of the method, with special emphasis on usefulness of a new remote-controlled magnetic navigation system. The paper is based on our own scientific experience and literature identified through a non-systematic search in PubMed. The magnetic navigation system consists of two external electromagnets (to be placed on opposite sides of the patient), which guide an ablation catheter (with a small magnet at the tip of the catheter) to the target area in the heart. The accuracy of this procedure is higher than that with manual navigation. Personnel can be quickly trained to use remote magnetic navigation, but the procedure itself is time-consuming, particularly for patients with atrial fibrillation. The major advantage is a considerably lower radiation burden to both patient and operator, in some studies more than 50 %, and a corresponding reduction in physical strain on the operator. The incidence of procedure-related complications seems to be lower than that observed with use of manually operated ablation catheters. Work is ongoing to improve magnetic ablation catheters and methods that can simplify mapping procedures and improve efficacy of arrhythmia ablation. The basic cost for installing a complete magnetic navigation laboratory may be three times that of a conventional electrophysiological laboratory. The new magnetic navigation system has proved to be applicable during ablation for a variety of tachyarrhythmias, but is still under development.

Current Status and Future Directions of Ventricular Arrhythmia Ablation

Ventricular tachycardia (VT) catheter ablation has evolved over the past decade, allowing effective treatment of haemodynamically unstable and epicardial VTs in patients with structural heart disease previously not amenable to ablation. Catheter ablation reduces VT recurrences and thereby implantable cardioverter–defibrillator (ICD) shocks in 67–75% of patients, with a low incidence of procedure-related complications when performed in highly experienced centres. It can be life-saving in patients with electrical storm. Early use of ablation can be considered in selected patients who receive an ICD as an alternative to drug therapy provided that the procedure can be performed safely. Although acute results are promising, outcomes over the long-term are less favourable. An improved understanding of the VT substrate is mandatory for further advancement of a substrate-based ablation approach. Pre-procedural and intra-procedural imaging are likely to contribute to this. Whether catheter ablation will become first-line treatment for VT in structural heart disease and ultimately allow ICD implantation to be avoided in selected patients needs further evaluation.

Difficult Biliary Cannulation: Use of Physician Controlled Wire-Guided Cannulation Over a Pancreatic Duct Stent to Reduce the Rate of Precut Sphincterotomy

Background: Successful cannulation of the common bile duct (CBD) remains the benchmark for endoscopic retrograde cholangiopancreatography (ERCP). Difficult cannulation, particularly with the use of precut sphincterotomy, has been shown to be a risk factor for post-ERCP pancreatitis. While use of a pancreatic duct (PD) stent to facilitate biliary cannulation has been described, the majority of patients required precut sphincterotomy to achieve CBD cannulation. We report the performance characteristics of this technique in conjunction with physician controlled wire-guided biliary cannulation to minimize the need for precut. Methods: We performed a retrospective, cohort analysis of ERCPs performed by two experienced endoscopists at independent medical centers. Both endoscopists routinely use a PD stent to facilitate biliary cannulation prior to resorting to a precut sphincterotomy and to reduce the risk of post ERCP pancreatitis. All patients with native papillae undergoing ERCP between January, 2006 and April, 2008 were included. Routine cannulation and failure to cannulate either the PD or CBD were excluded. In cases of difficult biliary access where the PD is cannulated, a soft, 5Fr pancreatic stent is left in the PD without performing a pancreatic sphincterotomy. Following this, physician controlled wire-guided biliary cannulation is attempted using the PD stent to direct the sphincterotome into the biliary orifice. If cannulation is unsuccessful after several minutes, a precut sphincterotomy is performed over the PD stent or the procedure is terminated. We reviewed medical records to determine rates of PD stent placement to facilitate biliary cannulation as well as rate of precut sphincterotomy. Outcomes included biliary cannulation rate, frequency of precut sphincterotomy, and incidence of procedure-related complications. Results: 2,345 ERCPs were identified, 1,544 with native papillae. Among these, CBD and PD cannulation failed in 16 (1.0%), while 76 (4.9%) patients received a PD stent to facilitate biliary cannulation. Successful cannulation was achieved in 71 of 76 (93.4%) patients, 60 (78.9%) of whom did not require precut sphincterotomy. Complications included mild post-ERCP pancreatitis in 4 (5.3%) and aspiration in 1 (1.3%). Precut sphincterotomy was complicated by hemorrhage controlled during the procedure in 2 of 16 (12.5%). Conclusions: Physician controlled wire-guided cannulation over a PD stent facilitates biliary cannulation and significantly reduces the rate of precut sphincterotomy. Future studies should compare the use of a PD stent with other noninvasive techniques to promote safe and effective biliary cannulation.

Comeback for glycoprotein IIb/IIIa inhibitors during percutaneous coronary interventions for saphenous vein bypass grafts: may be for distal protection with filter-based devices?The opinions expressed in this article are not necessarily those of the Editors of the European Heart Journal or of the European Society of Cardiology.

This editorial refers to ‘Platelet glycoprotein IIb/IIIa receptor inhibition as adjunctive treatment during saphenous vein graft stenting: differential effects after randomization to occlusion or filter-based embolic protection’† by M. Jonas et al., on page 920 Long-term outcome of coronary bypass surgery (CABG) is limited by progressive and significant narrowing of vein grafts in about half the patients within 10 to 15 years after operation.1 Despite a reduced world-wide trend for bypass operations and more widespread utilization of arterial conduits during CABG, treatment of symptomatic patients with degenerated aorto-coronary bypass vein grafts will remain a challenge of interventional cardiology. Bare metal coronary stents have improved long-term outcome after percutaneous coronary intervention (PCI) for saphenous vein grafts (SVG), by reducing restenosis when compared with balloon angioplasty, whereas many devices such as covered stents have failed to show additional benefit. Stent placement in SVG, however, carries up to 20% incidence of procedure-related complications mainly because of distal embolization, especially in old, diffusely diseased vein grafts.2 Because of an even greater risk associated with surgical re-intervention, PCI is a tempting alternative for revascularization in the majority of patients with vein graft disease. Preliminary long-term results with increased utilization of drug eluting stents during vein graft PCI are encouraging.3 The SAFER trial demonstrated that acute atherothrombotic, embolic complications associated with vein graft PCI can be roughly halved by the use of distal protection based on balloon occlusion and aspiration system, even in a cost-effective way.2,4 Even though risk of adverse … *Corresponding author. Tel: +358 3 3116 4312; fax: +358 3 3116 4157. E-mail address : kari.niemela{at}pshp.fi

Endovascular stent graft repair of abdominal and thoracic aortic aneurysms: a ten-year experience with 817 patients.

On November 23, 1992, the first endovascular stent graft (ESG) repair of an aortic aneurysm was performed in North America. Following the treatment of this patient, we have continued to evaluate ESG over the past 10 years in the treatment of 817 patients. Abdominal (AAA) or thoracic (TAA) aortic aneurysms are a significant health concern traditionally treated by open surgical repair. ESG therapy may offer protection from aneurysm rupture with a reduction in procedure morbidity and mortality. Over a 10-year period, 817 patients were treated with ESGs for AAA (723) or TAA (94). Patients received 1 of 12 different stent graft devices. Technical and clinical success of ESGs was reviewed, and the incidence of procedure-related complications was analyzed. The mean age was 74.3 years (range, 25-95 years); 678 patients (83%) were men; 86% had 2 or more comorbid medical illnesses, 67% of which included coronary artery disease. Technical success, on an intent-to-treat basis was achieved in 93.8% of patients. Primary clinical success, which included freedom from aneurysm-related death, type I or III endoleak, graft infection or thrombosis, rupture, or conversion to open repair was 65 +/- 6% at 8 years. Of great importance, freedom from aneurysm rupture after ESG insertion was 98 +/- 1% at 9 years. There was a 2.3% incidence of perioperative mortality. One hundred seventy five patients died of causes not related to their aneurysm during a mean follow-up of 15.4 months. Stent graft therapy for aortic aneurysms is a valuable alternative to open aortic repair, especially in older sicker patients with large aneurysms. Continued device improvements coupled with an enhanced understanding of the important role of aortic pathology in determining therapeutic success will eventually permit ESGs to be a more durable treatment of aortic aneurysms.

Localised Prostate Cancer: Important Points of Conduct for Radical Retropubic Prostatectomy

Radical prostatectomy offers the best chance of cure for patients with organ-confined prostate cancer. However, until approximately 15 years ago the procedure was associated with high morbidity, including excessive blood loss, urinary incontinence, and erectile dysfunction. Now, advances in radical retropubic techniques have led to better outcome in terms of tumour control and the incidence of procedure-related complications. This article proposes seven surgical goals for improved success rates after radical prostatectomy: (1) venous plexus control without the need for transfusion; (2) complete capsular micropedicle release along the nerve bundle; (3) nerve bundle release at the prostate apex before urethral transection; (4) complete sphincter preservation; (5) urethral transection near the verumontanum, the same limit as transuretheral resection of the prostate; (6) independent seminal vesicle tip removal if necessary for pelvic plexus preservation; and (7) preservation of the pelvic floor, the puboperinealis ‘quick-stop’ muscle. Also outlined are the important points of conduct for radical retropubic prostatectomy, best practice in preparing for surgery, and some crucial surgical tips. Employing these points of conduct and surgical tips should increase the chance of ensuring that the patient achieves long-term, tumour-free survival and an excellent quality of life provided by full functional recovery.

Randomized trial of a distal embolic protection device during percutaneous intervention of saphenous vein aorto-coronary bypass grafts

Background. Stents provide effective treatment for stenotic saphenous venous aorto-coronary bypass grafts, but their placement carries a 20% incidence of procedure-related complications, which potentially are related to the distal embolization of atherosclerotic debris. We report the first multicenter randomized trial to evaluate use of a distal embolic protection device during stenting of such lesions. Methods and Results. Of 801 eligible patients, there were 406 randomly assigned to stent placement over the shaft of the distal protection device, and 395 were assigned to stent placement over a conventional 0.014 angioplasty guidewire (control group). The primary endpoint - a composite of death, myocardial infarction, emergency bypass, or target lesion revascularization by 30 days - was observed in 65 patients (16.5%) assigned to the control group, and 39 patients (9.6%) assigned to the embolic protection device (p = 0.004). This 42% relative reduction in major adverse cardiac events was driven by myocardial infarction (8.6% versus 14.7%; p = 0.008) and no-reflow phenomenon (3% versus 9%; p = 0.02). Clinical benefit was seen even when platelet glycoprotein IIb/IIIa receptor blockers were administered (61% of patients), with composite endpoints occurring in 10.7% of protection device patients versus 19.4% of control patients (p = 0.008). Conclusions. Use of this distal protection device during stenting of stenotic venous grafts was associated with a highly significant reduction in major adverse events compared with stenting over a conventional angioplasty guidewire. This demonstrates the importance of distal embolization in causing major adverse cardiac events and the value of embolic protection devices in preventing such complications.

Randomized Trial of a Distal Embolic Protection Device During Percutaneous Intervention of Saphenous Vein Aorto-Coronary Bypass Grafts

Stents provide effective treatment for stenotic saphenous venous aorto-coronary bypass grafts, but their placement carries a 20% incidence of procedure-related complications, which potentially are related to the distal embolization of atherosclerotic debris. We report the first multicenter randomized trial to evaluate use of a distal embolic protection device during stenting of such lesions. Of 801 eligible patients, 406 were randomly assigned to stent placement over the shaft of the distal protection device, and 395 were assigned to stent placement over a conventional 0.014-inch angioplasty guidewire (control group). The primary end point-a composite of death, myocardial infarction, emergency bypass, or target lesion revascularization by 30 days-was observed in 65 patients (16.5%) assigned to the control group and 39 patients (9.6%) assigned to the embolic protection device (P=0.004). This 42% relative reduction in major adverse cardiac events was driven by myocardial infarction (8.6% versus 14.7%, P=0.008) and "no-reflow" phenomenon (3% versus 9%, P=0.02). Clinical benefit was seen even when platelet glycoprotein IIb/IIIa receptor blockers were administered (61% of patients), with composite end points occurring in 10.7% of protection device patients versus 19.4% of control patients (P=0.008). Use of this distal protection device during stenting of stenotic venous grafts was associated with a highly significant reduction in major adverse events compared with stenting over a conventional angioplasty guidewire. This demonstrates the importance of distal embolization in causing major adverse cardiac events and the value of embolic protection devices in preventing such complications.

Routine surveillance endomyocardial biopsy continues to detect significant rejection late after heart transplantation

Background The need for continued surveillance endomyocardial biopsies beyond the first year after cardiac transplantation is controversial. We evaluated the incidence of rejections requiring treatment (International Society Heart and Lung Transplantation grade 3A or greater) in patients 5 years or more after heart transplantation. Methods We conducted a retrospective chart review of all patients who underwent at least 1 endomyocardial biopsy at our center 5 years or more after heart transplantation. Results A total of 461 biopsies were performed in 77 patients 5 or more years after heart transplantation. Nine episodes of grade 3A or greater rejection were identified in 8 of 77 patients (10%). During the first year, 7.6% of biopsies were grade 3A or greater. Grade 3A rejection occurred in approximately 3.5% to 4% of biopsies during years 2 to 7. The overall incidence of procedural related complications at our institution was < 0.5%. Conclusion Endomyocardial biopsies continue to detect clinically significant rejection beyond 5 years after cardiac transplantation. The overall incidence of procedural related complications requiring treatment was low and none was life threatening. The absence of early rejection does not predict freedom from late rejection. Therefore, we continue to recommend surveillance biopsies in cardiac transplant recipients late after transplantation.

Aortoiliac stent deployment versus surgical reconstruction: Analysis of outcome and cost

Purpose:The purpose of this study is to compare complication rate, primary patency, and cost of stent deployment with direct surgical reconstruction for the treatment of severe aortoiliac occlusive disease. Methods:From March 1, 1992, to May 31, 1996, 119 patients receiving treatment for aortoiliac occlusive disease were analyzed after exclusions. Sixty-five patients had stent deployment and 54 patients had surgical reconstruction. Data were evaluated within and between the groups by univariate and multivariate logistic regression, life-table, t-test, and cross tabulation with χ 2 analysis. Results:There was no significant difference between the groups with regard to demographic features or presenting symptoms (all p values > 0.07). Incidence of procedure-related complications was similar ( p = 0.30). However, there were more systemic complications in the surgery group (15 versus 2; RR = 5.5, p < 0.01) and more vascular complications in the stent group (16 versus 3; RR = 12, p < 0.002). Incidence and type of late complications were not appreciably different (all p values > 0.05). Cumulative primary patency rate of bypass grafts was significantly better than stented iliac arteries at 18 months (93% versus 77%), 30 months (93% versus 68%) and 42 months (93% versus 68%); p = 0.002, log rank. Multivariate analysis identified female gender (RR = 4.6, p = 0.03), ipsilateral SFA occlusion (RR = 5.6, p = 0.01), procedure-related vascular complication (RR = 9.7, p = 0.002), and hypercholesterolemia (RR = 5.0, p = 0.02) as independent predictors of bypass graft or stent thrombosis. Mean total hospital cost per limb treated did not differ significantly between surgery and stent deployment groups ($9383 versus $8626, respectively; p = 0.66, t-test). Conclusions:Treatment of severe aortoiliac occlusive disease by surgical reconstruction or stent deployment has a similar complication rate. Mean hospital cost per limb treated is essentially equal. However, cumulative primary patency rate of bypass grafts is superior to stents. Therefore, considering the elements of cost and patency, surgical revascularization has greater value. The benchmark for cost-effective treatment of severe aortoiliac occlusive disease is direct surgical reconstruction. (J Vasc Surg 1998;28:94-103.)

Treatment of In-Stent Coronary Restenosis by Excimer Laser Angioplasty

We evaluated the efficacy and safety of excimer laser angioplasty (ELCA) with adjunctive balloon angioplasty in patients with restenotic or occluded coronary stents. ELCA was performed in 70 patients (60 ± 9 years), who had previously been treated with Micro Stents (n = 65), Palmaz–Schatz (n = 38), Wiktor, NIR, Freedom, and Multi-Link stents (n = 1 each). Restenosis (≥50% diameter stenosis) was documented in 90 stents, another 17 stents were occluded. Laser energy was delivered to the lesions with catheters 1.4, 1.7 (eccentric), and 2.0 mm in diameter. Procedural success was controlled by intravascular ultrasound in a subgroup. Laser catheters crossed all restenotic or occluded stents and decreased diameter stenosis from 80 ± 13% to 44 ± 11% (p <0.001). Adjunctive balloon angioplasty further reduced diameter stenosis to 13 ± 13% (p <0.001). In 13 patients with 21 stents, serial intravascular ultrasound imaging revealed a reduction of plaque area within the stent by 34 ± 22% (from 4.2 ± 1.8 mm 2 to 2.7 ± 1.1 mm 2) after ELCA and a reduction by 65 ± 16% (to 1.5 ± 0.7 mm 2) after balloon angioplasty (p <0.01). There were 4 patients with an increase of creatine kinase levels, 8 patients with major dissections (in 7 patients they were related to adjunctive balloon angioplasty), 1 patient with distal embolization, 2 with minor perforations, and 1 patient with stent dislocation. Reintervention during hospitalization was necessary in 3 patients. ELCA is an efficient and safe technique to debulk tissue in restenotic lesions and total occlusions within stents. The incidence of procedure related complications was low.

The Multicentre European Radiofrequency Survey (MERFS): complications of radiofrequency catheter ablation of arrhythmias. The Multicentre European Radiofrequency Survey (MERFS) investigators of the Working Group on Arrhythmias of the European Society of Cardiology.

Radiofrequency (RF) catheter ablation has developed into a new non-pharmacological therapy for the definitive treatment of patients with cardiac arrhythmias. Although an increasing number of recent reports have indicated the widespread use of the procedure, no data are available to estimate the number of procedures performed in Europe. Furthermore, currently no data on a large series of patients are available that provide information on the risk of procedure-related complications. This report presents the results of the Multicentre European Radiofrequency Survey (MERFS) that was conducted by the Working Group on Arrhythmias of the European Society of Cardiology. The objectives of this voluntary retrospective survey were to assess the number of radiofrequency catheter ablation procedures performed in 86 European institutions from January 1987 until March 1992 and the incidence of procedure-related complications with respect to the different types of ablative procedures. A total of 4398 patients were reported on from 68 out of 86 institutions (79%) from 15 European countries that agreed to participate in MERFS. From 1987 to 1991, the number of patients who underwent RF ablation per year increased from 45 to 2000. In the first 3 months of 1992, a total of 1640 patients were reported on. The number of patients reported on in relation to the different types of ablative procedures were: ablation of atrial tachycardialatrial flutter: n = 141 (3.2%); ablation of the atrioventricular junction: n = 900 (20.5%); modification of the atrioventricular junction in atrioventricular nodal reentrant tachycardia: n = 815 (18.5%); ablation of accessory pathway: n = 2222 (50.5%); ablation of ventricular tachycardia: n = 320 (7.3%). Procedure-related complications occurred in 223 patients (5.1%). The incidence of complications in relation to the ablative procedure was: ablation of atrial tachycardia/atrial flutter: 5.0%; ablation of the atrioventricular junction: 3.2%; modification of the atrioventricular junction in atrioventricular nodal reentrant tachycardia: 8.0%; ablation of accessory pathway: 4.4%; ablation of ventricular tachycardia: 7.5%. Complications occurred significantly more often in patients who underwent modification of the atrioventricular junction in atrioventricular nodal reentrant tachycardia, when compared to ablation of the atrioventricular junction (P < 0.001) or ablation of accessory pathway (P < 0.001), and in patients who underwent ablation of ventricular tachycardia, when compared to ablation of the atrioventricular junction (P < 0.002) or ablation of accessory pathway (P < 0.02). The highest incidence of complications was reported after modification of the atrioventricular junction in atrioventricular nodal reentrant tachycardia.(ABSTRACT TRUNCATED AT 400 WORDS)