Showing papers by "Lenox Hill Hospital published in 2001"

Localized intracoronary gamma-radiation therapy to inhibit the recurrence of restenosis after stenting

Abstract: Background Although the frequency of restenosis after coronary angioplasty is reduced by stenting, when restenosis develops within a stent, the risk of subsequent restenosis is greater than 50 percent. We report on a multicenter, double-blind, randomized trial of intracoronary radiation therapy for the treatment of in-stent restenosis. Methods Of 252 eligible patients in whom in-stent restenosis had developed, 131 were randomly assigned to receive an indwelling intracoronary ribbon containing a sealed source of iridium-192, and 121 were assigned to receive a similar-appearing nonradioactive ribbon (placebo). Results The primary end point, a composite of death, myocardial infarction, and the need for repeated revascularization of the target lesion during nine months of follow-up, occurred in 53 patients assigned to placebo (43.8 percent) and 37 patients assigned to iridium-192 (28.2 percent, P=0.02). However, the reduction in the incidence of major adverse cardiac events was determined solely by a diminish...

The association between head injuries and psychiatric disorders: findings from the New Haven NIMH Epidemiologic Catchment Area Study.

Abstract: Primary objective : To determine the association of report of any history of head injury with loss of consciousness or confusion and a lifetime diagnosis of psychiatric disorder in a general population. Research design : A probability sample of adults from the New Haven portion of the NIMH Epidemiologic Catchment Area programme were administered standardized and validated structured interviews. The main outcome measureswere lifetime prevalence of psychiatric disorders and suicide attempt in individuals with and without a history of traumatic brain injury. Main outcomes and results : Among 5034 individuals interviewed, 361 admitted to a history of severe brain trauma with loss of consciousness or confusion (weighted rate of 8.5/100). When controlling for sociodemographic factors, quality of life indicators and alcohol use, risk was increased for major depression, dysthymia, panic disorder, OCD, phobic disorder and drug abuse/dependence. In addition, lifetime risk of suicide attempt was greater in those who...

Results of the study to determine rotablator and transluminal angioplasty strategy (STRATAS)

Abstract: Rotational atherectomy is used to debulk calcified or complex coronary stenoses. Whether aggressive burr sizing with minimal balloon dilation ( 0.70 alone, or with adjunctive balloon inflation or =4 atm). Patient age was 62 +/- 11 years. Fifty-nine percent routine and 60% aggressive strategy patients had class III to IV angina. Fifteen percent routine and 16% aggressive strategy patients had a restenotic lesion treated; lesion length was 13.6 versus 13.7 mm. Reference vessel diameter was 2.64 mm. Maximum burr size (1.8 vs 2.1 mm), burr/artery ratio (0.71 vs 0.82), and number of burrs used (1.9 vs 2.7) were greater for the aggressive strategy, p 5 times normal in 7% of the routine versus 11% of the aggressive group. CK-MB elevation was associated with a decrease in rpm of >5,000 from baseline for a cumulative time >5 seconds, p = 0.002. At 6 months, 22% of the routine patients versus 31% of the aggressive strategy patients had target lesion revascularization. Angiographic follow-up (77%) showed minimum lumen diameter to be 1.26 mm in the routine group versus 1.16 mm in the aggressive group, and the loss index 0.54 versus 0.62. Dichotomous restenosis was 52% for the routine strategy versus 58% for the aggressive strategy. Multivariable analysis indicated that left anterior descending location (odds ratio 1.67, p = 0.02) and operator-reported excessive speed decrease >5,000 rpm (odds ratio 1.74, p = 0.01) were significantly associated with restenosis. Thus, the aggressive rotational atherectomy strategy offers no advantage over more routine burr sizing plus routine angioplasty. Operator technique reflected by an rpm decrease of >5,000 from baseline is associated with CK-MB elevation and restenosis.

Correction of limb-length inequality during total hip arthroplasty

Abstract: Although several methods of intraoperative limb-length measurements have been described, their success in predicting the limb-length correction is not well documented. A new technique of measuring intraoperative limb lengthening using a vertical Steinmann pin at the infracotyloid groove of the acetabulum was studied in 100 consecutive primary total hip arthroplasties. Correlation of the predicted intraoperative correction was done with the postoperative radiographic measurements. Preoperative limb-length inequality ranged from -24 mm (short) to +2 mm (long) (mean, -4.2 mm). Intraoperative measurement of lengthening ranged from 0 to 15 mm (mean, 5.9 mm). Radiographic measurements of postoperative radiographs showed lengthening ranging from 0 to 17 mm (mean, 7.4 mm). There was significant correlation between the 2 values (r =.84). Postoperative limb-length inequality ranged from -7 mm to +8 mm (mean, 1.9 mm). None of the patients had to use shoe lifts for equalization of limb lengths.

Effect of gender on the outcomes of contemporary percutaneous coronary intervention.

Abstract: Limited information exists regarding the outcomes of newer percutaneous coronary intervention (PCI) technologies in women. This study sought to determine whether female gender is an independent risk factor for PCI mortality and/or complications in contemporary practice. Using information from the National Cardiovascular Network (NCN) Database on 109,708 (33% women) PCI cases from 22 hospitals between January 1994 and January 1998, we examined the association of gender with unadjusted and risk-adjusted procedural outcomes. Women undergoing PCI were older, smaller, and had more comorbid illness than men, but less extensive coronary disease. Temporal trends in PCI device selection were similar in men and women. Compared with men, women had higher unadjusted procedural mortality rates (1.8% vs 1.0%, p <0.001), more strokes (0.4% vs 0.2%, p <0.001), and higher vascular complication rates (5.4% vs 2.7%, p <0.001). However, after adjusting for baseline clinical risk factors, and importantly, body surface area, women and men had similar PCI mortality risks (adjusted odds ratio 1.07, 95% confidence interval 0.92 to 1.24). Gender was not an independent risk factor for mortality among subgroups receiving coronary stent or atherectomy devices after risk adjustment. However, women undergoing PCI remained at higher risk for stroke, vascular complications, and repeat in-hospital revascularization than men, even after risk adjustment. We conclude that in contemporary practice, a patient's body size rather than gender, conveys independent risk for mortality after PCI.

Transanal hemorrhoidal dearterialization is an alternative to operative hemorrhoidectomy.

Abstract: Background: Transanal hemorrhoidal dearterialization (THD), a new approach for patients who would otherwise require an operative hemorrhoidectomy, accomplishes hemorrhoidal symptom relief with far less postoperative pain than an operative hemorrhoidectomy. Methods: THD, an ambulatory procedure, employs a specially designed proctoscope coupled with a Doppler transducer to allow identification and suture ligation of the hemorrhoidal arteries. Results: Sixty patients between ages 22 and 87 were treated. Bleeding was fully corrected in 88%, protrusion in 92%, and pain in 71%. Two patients (3%) failed to improve with THD. Complications included pain resulting in greater than 2 days loss of work in 5 patients, postoperative perirectal thromboses developed in 4 patients, and an anal fissure developed in 1 patient. Conclusions: THD was an effective alternative to operative hemorrhoidectomy. It may be the only option for patients where an operative hemorrhoidectomy is contraindicated because of incontinence.

Final results of a randomized trial comparing the nir stent to the palmaz-schatz stent for narrowings in native coronary arteries

Abstract: The MULTI-LINK (ML) stent is a novel second generation coronary stent. The ACS MultiLink Stent Clinical Equivalence in De Novo Lesions Trial (ASCENT) randomized 1,040 patients with single, de novo native vessel lesions to treatment with the ML stent or the benchmark Palmaz-Schatz (PS) stent, to demonstrate that the ML stent was not inferior to (i.e., equivalent or better than) the PS stent in terms of target vessel failure by 9 months. Successful stent delivery was achieved in 98.8% versus 96.9% of patients, with a slightly lower postprocedural diameter stenosis (8% vs 10%, p = 0.04), and no difference in 30-day major adverse cardiac events (5.0% vs 6.5%) for the ML stent versus the PS stent. The primary end point of target vessel failure at 9 months was seen in 15.1% of ML-treated patients versus 16.7% of PS-treated patients, with the ML proving to be equal or superior to the PS stent (p <0.001 by test for equivalency). In a prespecified subset, angiographic restudy showed a nonsignificant trend for reduced ML restenosis (16.0% vs 22.1%). Thus, the ML stent showed excellent deliverability and acute results, with 9-month clinical and 6-month angiographic outcomes that were equivalent or better than the PS stent.

Organizing the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST): National Institutes of Health, Health Care Financing Administration, and industry funding

Abstract: The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is a prospective, randomized, multicenter clinical trial of carotid endarterectomy (CEA) versus carotid artery stenting (CAS) as prevention for stroke in patients with symptomatic stenosis greater than or equal to 50%. CREST is sponsored by the US National Institute of Neurological Disorders and Stroke (NINDS) of the US National Institutes of Health (NIH), with additional support by a device manufacturer, and will provide data to the US Food and Drug Administration (FDA) for evaluation of a stent device. Because of budget constraints for CREST, Health Care Financing Administration (HCFA) reimbursement for hospital costs incurred by CREST patients will be essential. The involvement of academic scientists, industry, and three separate government agencies (NIH, FDA, HCFA) has presented many challenges in conducting the trial. A review of the pathways followed to meet these challenges may be helpful to others seeking to facilitate sharing of the costs and burdens of conducting innovative clinical research.

Early fracture of the sacrum or pelvis: an unusual complication after multilevel instrumented lumbosacral fusion.

Abstract: STUDY DESIGN A retrospective review of a series of cases with a complication of instrumented lumbosacral fusion. OBJECTIVES To present a previously undescribed complication, early sacral or pelvic stress fracture, after instrumented lumbosacral fusion and to identify the risk factors associated with this complication. BACKGROUND There are a number of well-described complications of instrumented lumbosacral fusion, including delayed stress fracture of the pelvis. Early sacral or pelvic stress fracture after instrumented lumbosacral fusion has not been previously reported, to the authors' knowledge. METHODS The authors present three cases of early stress fracture occurring at 2-4 weeks after surgery in patients who underwent instrumented multilevel lumbosacral fusions for degenerative lumbosacral disease. RESULTS Two patients had sacral fracture, which to the authors' knowledge, has not been previously reported. Risk factors included lumbosacral instrumentation and fusion, osteoporosis in elderly women, and iliac crest bone graft procurement. All patients were treated conservatively, with restricted ambulation and gradual return to activity. CONCLUSION This complication can cause significant morbidity and a delay in the patient's return to function. A better understanding of the related biomechanical forces and preoperative risk factors may identify patients at risk and may aid in surgical planning and in expectations of postoperative recovery.

Stray radiation in the cardiac catheterisation laboratory.

Abstract: Staff radiation risk is related to the radiation field in which individuals work. Traditional protective measures focus on reducing stochastic risk. However, deterministic injury to the operator's hands cannot always be ignored. The stray radiation field is almost totally attributable to scatter from the patient. Its relative intensity is greatest near the entry port of the useful beam into the patient. The entry port moves during the procedure as the operator selects various required projections. Therefore, the relative exposure rate at any particular location in the laboratory changes with the clinical projection. The absolute scatter intensity is also dependent on the size and strength of the useful beam. Operators may put their hands near or in the useful beam. Leaded surgical gloves provide some overall finger protection for scatter fields. However, because of automatic dose rate controls, these gloves often increase risk when the operator's hands are seen on the image monitor.

Extent and distribution of in-stent intimal hyperplasia and edge effect in a non-radiation stent population.

Abstract: Intimal hyperplasia within the body of the stent is the primary mechanism for in-stent restenosis; however, stent edge restenosis has been described after brachytherapy. Our current understanding about the magnitude of in vivo intimal hyperplasia and edge restenosis is limited to data obtained primarily from select, symptomatic patients requiring repeat angiography. The purpose of this study was to determine the extent and distribution of intimal hyperplasia both within the stent and along the stent edge in relatively nonselect, asymptomatic patients scheduled for 6-month intravascular ultrasound (IVUS) as part of a multicenter trial: Heparin Infusion Prior to Stenting. Planar IVUS measurements 1 mm apart were obtained throughout the stent and over a length of 10 mm proximal and distal to the stent at index and follow-up. Of the 179 patients enrolled, 140 returned for repeat angiography and IVUS at 6.4 ± 1.9 months and had IVUS images adequate for analysis. Patients had 1.2 ± 0.6 Palmaz-Schatz stents per vessel. There was a wide individual variation of intimal hyperplasia distribution within the stent and no mean predilection for any location. At 6 months, intimal hyperplasia occupied 29.3 ± 16.2% of the stent volume on average. Lumen loss within 2 mm of the stent edge was due primarily to intimal proliferation. Beyond 2 mm, negative remodeling contributed more to lumen loss. Gender, age, vessel location, index plaque burden, hypercholesterolemia, diabetes, and tobacco did not predict luminal narrowing at the stent edges, but diabetes, unstable angina at presentation, and lesion length were predictive of in-stent intimal hyperplasia. In a non-radiation stent population, 29% of the stent volume is filled with intimal hyperplasia at 6 months. Lumen loss at the stent edge is due primarily to intimal proliferation.

Carotid angioplasty with stenting in post-carotid endarterectomy restenosis.

Abstract: Recurrent stenosis post-carotid endarterectomy (CEA) is not a solitary or unusual phenomenon. Compared to the initial CEA, the reoperation is often more technically challenging and frequently results in local and neurological complications. Carotid artery angioplasty with stenting (CAS) is currently being investigated as an alternative to carotid endarterectomy. In our study, ninety-nine patients underwent CAS in 110 arteries. Procedural success was 99% (109/110). Our results show that CAS treatment in post-CEA restenosis, especially with improved technique and distal protection, is safe with a low neurological complication rate, without any "local" complications and without any cranial nerve palsies. This study suggests that the future primary mode of treatment of post-CEA restenosis might be carotid stenting rather than surgery.

Clinical and angiographic outcome in the laser angioplasty for restenotic stents (LARS) multicenter registry.

Abstract: In-stent restenosis (ISR), when treated with balloon angioplasty (PTCA) alone, has an angiographic recurrence rate of 30%–85%. Ablating the hypertrophic neointimal tissue prior to PTCA is an attractive alternative, yet the late outcomes of such treatment have not been fully determined. This multicenter case control study assessed the angiographic and clinical outcomes of 157 consecutive procedures in 146 patients with ISR at nine institutions treated with either PTCA alone (n = 64) or excimer laser assisted coronary angioplasty (ELCA, n = 93)) for ISR. Demographics were similar except more unstable angina at presentation in ELCA-treated patients (74.5% vs. 63.5%; P = 0.141). Lesions selected for ELCA were longer (16.8 ± 11.2 mm vs. 11.2 ± 8.6 mm; P < 0.001), more complex (ACC/AHA type C: 35.1% vs. 13.6%; P < 0.001), and with compromised antegrade flow (TIMI flow < 3: 18.9% vs. 4.5%; P = 0.008) compared to PTCA-treated patients. ELCA-treated patients had similar rate of procedural success [93 (98.9% vs. 62 (98.4%); P = 1.0] and major clinical complications [1 (1.1%) vs. 1 (1.6%); P = 1.0]. At 30 days, repeat target site coronary intervention was lower in ELCA-treated patients (1.1% vs. 6.4% in PTCA-treated patients; P = 0.158), but not significantly so. At 1 year, ELCA-treated patients had similar rate of major cardiac events (39.1% vs. 45.2%; P = 0.456) and target lesion revascularization (30.0% vs. 32.3%; P = 0.646). These data suggest that ELCA in patients with complex in-stent restenosis is as safe and effective as balloon angioplasty alone. Despite higher lesion complexity in ELCA-treated patients, no increase in event rates was observed. Future studies should evaluate the relative benefit of ELCA over PTCA alone for the prevention of symptom recurrence specifically in patients with complex in-stent restenosis. Cathet Cardiovasc Intervent 2001;52:24–34. © 2001 Wiley-Liss, Inc.

Malignant disease in pregnancy.

Abstract: Cancers in pregnancy are uncommon but do occur with an average frequency of 1 in 1,000 births. This gives rise to opposing emotional reactions in these women: they are happy they are pregnant, but usually devastated when they hear they have cancer. The major reasons for suspecting that pregnancy adversely affects the clinical course of cancer is the immunologic tolerance that characterizes both conditions. It has been pointed out that normal pregnancy and cancer are the only two biologic conditions in which the antigenic tissues is tolerated by a seemingly intact system. It may be stated that the mechanisms that insure the survival of fetus during pregnancy presumably also favors the progress of the neoplasia. Management requires individualization with careful thought as whether termination is necessary or whether continuing with the pregnancy is possible prior to definitive treatment. The physician's aim must be to cure the cancer and deliver live, healthy infants. This is one question when a joint decision is probably best reached among the obstetrician, surgical and medical oncologists and other disciplines. The life-threatening cancer should be managed both for the diagnosis and treatment as in the non-pregnant state. An early small cancer gives a better prognosis than an advanced cancer. The same holds for the non-pregnant patient. The survival in the non-pregnant patient stage for stage is the same as for the pregnant patient. However, all too often in the pregnant state the cancer is more advanced than in the non-pregnant patient. The disease must be evaluated and treated in full light of its exact location in conjunction with an understanding of the natural history within the context of the pregnancy with the potentially viable unborn infant. Concern that maternal cancer may metastasize to the fetus is not justified from a review of the accumulated literature. Infrequency of fetal involvement has led to speculation about biologic protective mechanisms that may exist for the placenta and the fetus and the role circulatory separation in the placenta and immunologic responses of the fetus may play. The association of cancer in pregnancy represents a major physiologic process for the maintenance of the race and a major pathologic process that accounts for numerous deaths. It presents a controlled growth and an uncontrolled growth in the same host.

Distraction laminoplasty for decompression of lumbar spinal stenosis.

Abstract: Distraction laminoplasty is a technical modification of routine laminectomy that allows decompression of the lumbar spinal canal with maximal bone preservation. The technique involves the application of a distraction force, in conjunction with an undercutting laminoplasty technique. It is safe, easily applied, and allows excellent canal visualization and decompression with minimal bone resection. The purpose of the current study is to describe the technical aspects of the technique.

Spinal cord and nerve root monitoring during surgical treatment of lumbar stenosis.

Abstract: The author describes application of intraoperative neurophysiologic monitoring to surgical treatment of lumbar stenosis. Benefits of somatosensory and motor evoked potential studies during surgical correction of spinal deformity are well known and documented. Free-running and evoked electromyographic studies during pedicle screw implantation is an accepted practice at many institutions. However, the functional integrity of spinal cord, cauda equina, and nerve roots should be monitored throughout every stage of surgery including exposure and decompression. Somatosensory evoked potentials monitor overall spinal cord function. Intraoperative electromyography provides continuous assessment of motor root function in response to direct and indirect surgical manipulation. Electromyographic activities observed during exposure and decompression of the lumbosacral spine included complex patterns of bursting and neurotonic discharge. In addition, electromyographic activities at distal musculature were elicited by impacting a surgical instrument or graft plug against bony elements of the spine. All electromyographic events provided direct feedback to the surgical team and were regarded as a cause for concern. Simultaneously monitored evoked potential and electromyographic studies protect spinal cord and nerve roots during seemingly low-risk phases of a surgical procedure when neurologic injury may occur and the patient is placed at risk for postoperative myelopathy or radiculopathy.

Design and rationale of CONTRAST--a prospective, randomized, placebo-controlled trial of fenoldopam mesylate for the prevention of radiocontrast nephropathy.

Abstract: Radiocontrast-induced nephropathy develops in approximately 10% to 20% of patients following administration of iodine-based dye and is one of the most prognostically detrimental complications that invasive cardiologists and radiologists encounter. Preexisting renal dysfunction and diabetes mellitus are two of the most powerful predictors of the likelihood of developing acute renal insufficiency after contrast delivery. To date, only adequate preprocedural hydration and postprocedural hydration to offset dehydration from contrast-induced diuresis have been shown to be effective in preventing this condition. Fenoldopam mesylate, a systemic vasodilator currently FDA-approved for short-term, in-hospital management of severe hypertension, has been shown to increase renal plasma flow in patients with and without chronic renal insufficiency. As a selective agonist of the dopamine-1 receptor, fenoldopam may preserve outer medullary renal blood flow and thereby attenuate radiocontrast-induced nephropathy. Small studies with fenoldopam prior to iodine-based dye administration have demonstrated low rates of radiocontrast nephropathy, and a larger, randomized trial has found that renal blood flow 1 hour after angiography rose in the fenoldopam group compared to a decline in the placebo group. The CONTRAST study has been designed to determine whether fenoldopam is indeed effective in diminishing the occurrence of radiocontrast-induced nephropathy.