Showing papers by "Lenox Hill Hospital published in 2000"

Final Results of the Can Routine Ultrasound Influence Stent Expansion (CRUISE) Study

Abstract: Background—Intravascular ultrasound (IVUS) can assess stent geometry more accurately than angiography. Several studies have demonstrated that the degree of stent expansion as measured by IVUS directly correlated to clinical outcome. However, it is unclear if routine ultrasound guidance of stent implantation improves clinical outcome as compared with angiographic guidance alone. Methods and Results—The CRUISE (Can Routine Ultrasound Influence Stent Expansion) study, a multicenter study IVUS substudy of the Stent Anti-thrombotic Regimen Study, was designed to assess the impact of IVUS on stent deployment in the high-pressure era. Nine centers were prospectively assigned to stent deployment with the use of ultrasound guidance and 7 centers to angiographic guidance alone with documentary (blinded) IVUS at the conclusion of the procedure. A total of 525 patients were enrolled with completed quantitative coronary angiography, quantitative coronary ultrasound, and clinical events adjudicated at 9 months for 499 ...

Prevalence of human papillomavirus DNA in different histological subtypes of cervical adenocarcinoma.

Abstract: The prevalence of human papilloma virus (HPV) DNA in different histological subtypes of cervical adenocarcinoma and related tumors was examined using formalin-fixed, paraffin-embedded tissue samples from 105 primary cervical adenocarcinomas and adenosquamous carcinomas. Broad-spectrum HPV DNA amplification and genotyping was performed with the SPF10 primer set and line probe assay (LiPA), respectively. HPV DNA was detected in 82 of 90 (91%) mucinous adenocarcinomas, encompassing endocervical, intestinal, and endometrioid histological subtypes, and in nine of nine adenosquamous tumors (100%). HPV DNA was not detected in any nonmucinous adenocarcinomas including clear cell, serous, and mesonephric carcinomas (0/6). The most common viral types detected in adenocarcinoma were HPV 16 (50%) and HPV 18 (40%), followed by HPV 45 (10%), HPV52 (2%), and HPV 35 (1%). Multiple HPV types were detected in 9.7% of the cases. In conclusion, mucinous adenocarcinomas and adenosquamous carcinomas of the cervix demonstrate a very high prevalence of HPV DNA, similar to that reported for cervical squamous cell carcinoma. Only rare histological variants of cervical adenocarcinoma seem unrelated to HPV infection.

Incidence, management, and outcome of coronary artery perforation during percutaneous coronary intervention.

Abstract: We have analyzed the incidence, management, and outcome of 84 cases of coronary artery perforation in patients who underwent percutaneous coronary intervention at our institution. This complication was more frequent in female patients and in patients who underwent lesion modification with atheroablative devices. A total of 8 patients (9.5%) died after the procedure. They were usually older and had a higher incidence of cardiac tamponade; a larger percentage of these patients underwent emergency surgery than those who survived.

Neuropsychiatric aspects of traumatic brain injury

Abstract: Traumatic brain injury (TBI) may produce a variety of neuropsychiatric problems, including impaired cognition, depression, mania, affective lability, irritability, anxiety, and psychosis. Despite the common occurrence of these symptoms following TBI, there are relatively few studies that provide clear guidance regarding management. Many symptoms (eg, irritability, affective lability, fatigue, sleep disturbance, and impaired cognition) are primarily consequences of brain injury rather than symptoms of a comorbid psychiatric disorder such as major depression. Although it is difficult to study the complicated treatments needed for such symptom complexes, we are able to recommend an approach to the evaluation and treatment of neuropsychiatric problems following traumatic brain injury. A thorough assessment of the patient is a prerequisite to the prescription of any treatment. This assessment should include a thorough developmental, psychiatric, and medication history; a detailed mental status examination; a complete neurologic examination; and quantification of neuropsychiatric symptoms using standardized and accepted inventories (eg, Neurobehavioral Rating Scale, Neuropsychiatric Inventory ). All symptoms must be evaluated in the context of the patient's premorbid history and current treatment because neuropsychiatric symptoms may be influenced by either factor or by both factors. Psychotherapy is an important component of the treatment of neuropsychiatric problems following TBI. Additionally, patients should be encouraged to become involved with local TBI support groups. When medications are prescribed, it is essential to use cautious dosing (low and slow) and empiric trials with continuous reassessment of symptoms using standardized scales and monitoring for drug-drug interactions. In general, medications with significant sedative, antidopaminergic, and anticholinergic properties should be avoided, and benzodiazepines should be used sparingly, if at all. Although patients with TBI may be particularly susceptible to adverse effects of psychopharmacologic medications, at times dosages similar to those used for the non-brain-injured psychiatric patient may be needed. When a single medication does not provide adequate relief of symptoms or cannot be tolerated at therapeutic doses, an alternative strategy is to augment the effect of one medication by using a second low-dose agent with a different mechanism of action.

Angiographic and clinical characteristics associated with increased in-hospital mortality in elderly patients with acute myocardial infarction undergoing percutaneous intervention (a pooled analysis of the primary angioplasty in myocardial infarction trials).

Abstract: Advanced age is associated with increased mortality in acute myocardial infarction (AMI) but the mechanism remains unclear. We performed a pooled analysis of 3,032 patients from the Primary Angioplasty in Myocardial Infarction (PAMI)-2, Stent-PAMI, and PAMI-No Surgery On Site trials to determine which clinical, hemodynamic, and angiographic characteristics in the elderly were associated with in-hospital death. There were 452 patients aged >/=75 years and 2,580 patients aged /=75 years, lower LV ejection fraction, lower final TIMI flow, higher Killip class, need for an intra-aortic balloon pump (IABP), and post-AMI stroke/transient ischemic attack, or significant arrhythmia. Despite avoiding thrombolysis, elderly patients remain at increased risk of bleeding, stroke, and other post-AMI complications, and death. Cardiac risk factor analysis and acute catheterization offer prognostic information but do not completely explain the mechanism of increased in-hospital mortality in the elderly.

Anthropometric measurements to design total knee prostheses for the Indian population

Abstract: An anthropometric computed tomography scan study was undertaken to design femoral components in 86 knees (47 osteoarthritic Indians—21 men, 26 women) who matched standards suggested by the Indian Council of Medical Research 1990. Patients were classified into 3 random groups based on anteroposterior diameter ( 59 mm). Most Indian men (86.8%) could have the femoral component satisfactorily replaced by available designs. A statistically significant number of women (60.4%, P 10 mm) in a given anteroposterior size was noted in all 3 groups. This pilot study representative of the Indian population can be used to manufacture prosthetic inventories suitable for most of the Asian-Pacific population having smaller anthropometric measurements than Western populations.

Safety, efficacy, and durability of carotid artery stenting for restenosis following carotid endarterectomy: a multicenter study.

Abstract: Purpose:To present the results of a multicenter registry established to collect data on carotid stent procedures in patients with restenosis following carotid endarterectomy.Methods:The procedural details, outcomes, and late follow-up results were collected from 14 centers in the United States. Thirty-day and late stroke and death rates were analyzed.Results:Three hundred and thirty-eight patients (201 men; 71 ± 8 years) underwent carotid stenting in 358 arteries. The average duration from carotid endarterectomy was 5.5 ± 7.3 years. Sixty-one percent of the patients were asymptomatic. The overall 30-day stroke and death rate was 3.7%. The minor stroke rate was 1.7% (6/358), and the major nonfatal stroke rate was 0.8% (3/358). The fatal stroke rate was 0.3% (1/358), and the nonstroke-related death rate was 0.9% (3/338). There was 1 (0.3%) fatal and 1 (0.3%) nonfatal stroke during the follow-up period. The overall 3-year rate of freedom from all fatal and nonfatal strokes was 96% ± 1% (±SE).Conclusions:Caro...

Randomized Comparison of GR-II Stent and Palmaz-Schatz Stent for Elective Treatment of Coronary Stenoses

Abstract: Background—This prospective multicenter randomized clinical trial was designed to evaluate the long-term angiographic and clinical outcomes of elective treatment with the GR-II stent compared with the Palmaz-Schatz (PS) stent in patients with coronary stenoses. Methods and Results—Seven hundred fifty-five patients with myocardial ischemia and de novo native coronary stenoses in 3- to 4-mm vessels were randomly assigned to the PS (375 patients) or the GR-II stent (380 patients). The primary end point was 12-month target lesion revascularization (TLR)-free survival. Angiography was performed at baseline and at follow-up in the first 300 consecutive patients to assess the frequency of angiographic restenosis. Procedure success was 98.5% for the GR-II stent and 99.4% for the PS stent (P=0.19). At 30 days, patients assigned to the GR-II stent had a higher stent thrombosis rate (3.9% versus 0.3% for PS stent, P<0.001) and TLR rate (3.9% versus 0.5% for PS stent, P<0.001). The GR-II group had a higher follow-up ...

Repair of chronic ruptures of the distal biceps tendon using flexor carpi radialis tendon graft.

Abstract: Five patients with chronic distal biceps tendon ruptures underwent tendon repair using double-looped flexor carpi radialis tendon graft. Fixation was performed with suture anchors through a single anterior incision. All patients had excellent functional results at a minimum 2-year follow-up.

Carotid artery stenting: technical considerations.

Abstract: BACKGROUND AND PURPOSE: Carotid endarterectomy (CEA) is one of the most frequently performed operations in the United States. To offer patients a less invasive means to achieve the same goal, carotid artery stenting (CAS) is investigated as an alternative treatment to CEA. METHODS: Three hundred ninety patients underwent CAS, with 451 vessels treated. CAS was performed using a coaxial system with a 7F 90-cm sheath for predilation, stent placement, and stent dilation. Pretreatment antiplatelet therapy was administered. We currently practice same-day admissions and 23-hour discharges. RESULTS: The technical success rate was 98%. The 30-day mortality/morbidity rates were as follows: death, 1.7% (two [0.5%] neurologic and five [1.2%] systemic] major strokes, 0.9% (two of four were related to the intervention); minor strokes, 5.5%. Among 25 patients who suffered minor strokes, 14 achieved complete recovery. On an annual basis, the incidence of minor stroke declined from 6.8% (1994–1995), to 5.8% (1995–1996), 5.3% (1996–1997), and then 4% (1997–1998), with no major strokes or neurologic deaths occurring during the 1997 to 1998 period. CONCLUSION: CAS is an effective treatment for carotid stenosis. With proper selection of patients and meticulous technique, complication rates compare favorably with those of CEA.

Follicular variant of papillary carcinoma: the diagnostic limitations of preoperative fine-needle aspiration and intraoperative frozen section evaluation.

Abstract: Objective Fine-needle aspiration (FNA) and frozen section (FS) have been widely reported in the literature as having high sensitivity in the diagnosis of papillary carcinoma. With the increased recognition of the follicular variant of papillary thyroid carcinoma (FVPTC), several reports have pointed out the difficulty in diagnosing this variant of papillary carcinoma owing to its overlapping cytomorphological features with benign and malignant follicular lesions. We undertook this study to determine the sensitivity of FNA and FS in the diagnosis of FVPTC. Methods Retrospective review of patients who underwent thyroidectomy from June 1994 to June 1999. Of the 63 patients found with a final pathological diagnosis of papillary thyroid carcinoma, only 47 had an adequate FNA and FS and were included in the study. These patients were divided into two groups, the usual type (n = 23) and the follicular variant (n = 24) of papillary carcinoma. Sensitivities of FNA and FS for these two groups of papillary carcinoma were then determined. Results The sensitivity of the FNA was 25% and of the FS was 29% for the follicular variant of papillary thyroid carcinoma. This is in contrast to the sensitivity of FNA and FS for the usual papillary carcinoma, which were 74% and 87%, respectively. Conclusion FNA and FS have low sensitivity in the diagnosis of the FVPTC. High degree of suspicion may increase the accuracy in the diagnosis of this variant of papillary carcinoma before or during surgery. However, the thyroid surgeon needs to realize that, like follicular carcinoma, FVPTC is often diagnosed only on final pathological examination.

Carotid stenting for severe radiation-induced extracranial carotid artery occlusive disease.

Abstract: PURPOSE To present our experience with carotid artery stenting as an alternative treatment to endarterectomy in patients with radiation-induced carotid artery occlusive disease. METHODS AND RESULTS Fourteen patients (10 males; mean age 61 years, range 52 to 79) underwent percutaneous stenting of 15 carotid arteries for severe radiation-induced extracranial stenoses. Technical success was achieved in all patients, with reduction of the mean stenosis from 77% +/- 6% to 8% +/- 2%. In 2 patients, ipsilateral vertebral artery lesions were stented concomitantly. One patient had a minor stroke after the procedure but recovered fully in 2 days. No other complications were encountered. Nine (64%) patients had 6-month follow-up imaging (angiography or duplex scanning) that showed no evidence of restenoses (obstruction > or = 50%). At 18 +/- 2 months, 3 (21%) patients had died from unrelated causes. No neurological events occurred, and no repeat carotid artery interventions were required in the remaining patients. CONCLUSIONS Carotid stenting is an effective treatment option for severe radiation-induced carotid artery occlusive disease.

Sonographic and clinical methods in the diagnosis of macrosomia.

Abstract: Receiver operator characteristic curves for both clinical and sonographic predictions of macrosomia subsume areas between 0.81 and 0.95, significantly larger than the area of 0.5 that indicates a useless test. Thus, these tests are defined as useful from a statistical point of view. Prediction of macrosomia by clinical or imaging techniques, however, is limited by the substantial false-positive and false-negative rates inherent in these tests. We recommend that physicians continue to use clinical methods to estimate fetal weight, including asking women with parity to provide their own estimates. We recognize that the relative error associated with clinical or sonographic estimates of fetal weight limits their use in clinical practice. Sonographic laboratories may improve their results by performing ROC curve analysis on their own data and by selecting cutoff values that best predict macrosomia in their setting. Serial sonographic measurements that are above the limits chosen to define macrosomia increase the likelihood that a birth weight will be macrosomic. Separate ROC curves must be generated for twins and breech presentations and for patients with diabetes to answer weight-related clinical questions such as mode and timing of delivery. Three-dimensional ultrasound and magnetic resonance imaging are expected to generate ROC curves for estimates of fetal weight that are better than those for two-dimensional ultrasound or clinical estimates. Such analyses have yet to be published.

Clinical and radiographic evaluation of the Harris-Galante Cup

Abstract: A retrospective evaluation of the clinical and radiographic results of the Harris-Galante acetabular cups was performed in 112 patients with 127 total hip arthroplasties. Patients with 14 hips had died, and patients with 20 hips were lost to follow-up. A total of 82 patients with 93 hips was available for follow-up. There were 67 men and 45 women. The mean follow-up was 87 months (range, 48–113 months). There were a total of 9 revisions: 2 for recurrent dislocations, 1 for a loose cup, and 6 for wear and osteolysis. Radiographic evaluation demonstrated that 22 (24%) hips had periacetabular osteolysis, and 16 of these 22 (73%) were associated with the screws. Twenty-two hips (23%) demonstrated osteolytic lesions around the femoral stem. Mean femoral head displacement was of 1.00 mm (range, 0.40–4.5 mm) with a rate of 0.16 mm/yr (range, 0.05–0.44 mm/yr). The Harris-Galante socket has maintained a low implant failure rate at intermediate term, even in these young patients. As follow-up increases, wear of the polyethylene and periprosthetic osteolysis may become growing concerns.

Effect of Intracoronary γ-Radiation Therapy on In-Stent Restenosis An Intravascular Ultrasound Analysis from the Gamma-1 Study

Abstract: Background—The aim of this study was to use serial volumetric intravascular ultrasound to evaluate the effect of g-radiation on recurrent in-stent restenosis. Methods and Results—After successful reintervention, patients were randomized to receive either 192 Ir or placebo. Intravascular ultrasound studies with motorized pullback (0.5 mm/s) were performed immediately after irradiation and at 8-month follow-up in 70 patients. Paired volumetric analysis of the stented segment and of 5-mm proximal and distal reference segments was performed; this included measurements of the external elastic membrane, lumen, plaque and media (external elastic membrane minus lumen), stent, and intimal hyperplasia (stent minus lumen). Baseline proximal reference, stent, and distal reference measurements were similar in both groups. The changes in proximal and distal reference measurements of the external elastic membrane, plaque and media, and lumen areas were similar in both groups. However, the decrease in stented segment lumen volume was less in the 192 Ir patients than the placebo patients (‐25634 mm 3 versus ‐ 48642 mm 3 ; P50.0225), and the increase in the volume of intimal hyperplasia in the stented segment was less in the 192 Ir patients than in the placebo patients (28637 mm 3 versus 50640 mm 3 ; P50.0352). When averaged over the length of the stented segment (32613 mm versus 33614 mm; P50.9), the increase in mean area of intimal hyperplasia was 0.861.0 mm 2 in the 192 Ir group and 1.661.2 mm 2 in the control group (P50.0065). Late stent-vessel wall malapposition was noted in one placebo patient and no 192 Ir patients. Conclusions— g-Radiation therapy can effectively prevent recurrent in-stent restenosis by inhibiting neointimal formation within the stent. At the stent edge, there were no significant differences between 192 Ir and placebo patients. (Circulation. 2000;102:2915-2918.)

Relationship of prostate-specific antigen and prostate volume in patients with biopsy proven benign prostatic hyperplasia.

Abstract: BACKGROUND Emerging data suggest a direct correlation between prostate-specific antigen (PSA) and prostate volume in patients with lower urinary tract symptoms (LUTS) and clinical evidence of benign prostatic hyperplasia (BPH). We attempt to confirm that a similar correlation exists between PSA and prostate volume in patients with biopsy-proven BPH. METHODS Over a 5 year period, 2,270 patients were confirmed to have BPH as the only histological diagnosis after evaluation with serum PSA, trans-rectal ultrasound (TRUS) biopsy, and prostate volume measurement. PSA and prostate volume were statistically analyzed by age-stratified cohorts, including multiple regression analysis and assessment of correlation using the Pearson correlation coefficient (r). RESULTS Mean PSA and prostate volume increased with each advancing cohort of age, and the correlation of PSA and prostate volume was determined to be statistically significant (P < 0.001) in each cohort with a correlation coefficient ranging from 0.33 to 0.41. CONCLUSIONS We confirm that the relationship between PSA and prostate volume in a large series of patients with biopsy-proven BPH provides a comparable correlation to data for patients with LUTS and clinical BPH. As such, PSA represents a valuable approximation of prostate volume, and may prove to be clinically useful in the management of patients with BPH. Prostate 45:315–319, 2000. © 2000 Wiley-Liss, Inc.

Short- and Intermediate-Term Clinical Outcomes From Direct Myocardial Laser Revascularization Guided by Biosense Left Ventricular Electromechanical Mapping

Abstract: Background —Direct myocardial revascularization (DMR) has been examined as an alternative treatment for patients with chronic refractory myocardial ischemic syndromes who are not candidates for conventional coronary revascularization. Methods and Results —We used left ventricular electromagnetic guidance in 77 patients with chronic refractory angina (56 men, mean age 61±11 years, ejection fraction 0.48±0.11) to perform percutaneous DMR with an Ho:YAG laser at 2 J/pulse. Procedural success (laser channels placed in prespecified target zones) was achieved in 76 of 77 patients with an average of 26±10 channels (range 11 to 50 channels). The rate of major in-hospital cardiac adverse events was 2.6%, with no deaths or emergency operations, 1 patient with postprocedural pericardiocentesis, and 1 patient with minor embolic stroke. The rate of out-of-hospital adverse cardiac events (up to 6 months) was 2.6%, with 1 patient with myocardial infarction and 1 patient with stroke. Exercise duration after DMR increased from 387±179 to 454±166 seconds at 1 month and to 479±161 seconds at 6 months ( P =0.0001). The time to onset of angina increased from 293±167 to 377±176 seconds at 1 month and to 414±169 seconds at 6 months ( P =0.0001). Importantly, the time to ST-segment depression (≥1 mm) also increased from 327±178 to 400±172 seconds at 1 month and to 436±175 seconds at 6 months ( P =0.001). Angina (Canadian Cardiovascular Society classification) improved from 3.3±0.5 to 2.0±1.2 at 6 months ( P Conclusions —Percutaneous DMR guided by left ventricular mapping is feasible and safe and reveals improved angina and prolonged exercise duration for up to a 6-month follow-up.

Polytetrafluoroethylene-covered stent for the treatment of narrowings in aorticocoronary saphenous vein grafts.

Abstract: We compared the outcome of patients with saphenous graft disease treated with polytetrafluoroethylene (PTFE)-covered stents or noncovered stents. Angiographic success was similar; non-Q-wave myocardial infarction was lower in the PTFE group (p = 0.06) and long-term major cardiac events and restenosis rate were similar in the 2 groups. Implantation of PTFE-covered stent in vein graft disease seems to reduce the occurrence of distal embolization.

Coronary stenting versus balloon angioplasty in small coronary artery with complex lesions.

Abstract: The impact of stenting on small vessels ( 40%). We compared early and late outcome of patients with complex coronary lesions in small vessel treated with traditional coronary angioplasty (angioplasty group) and with elective stent implantation (stent group). Angioplasty group (n = 97) and stent group (n = 112) were comparable for all clinical and angiographic characteristics. All patients in the two groups had clinical and angiographic follow-up. Major adverse cardiac events (MACE) and restenosis rate were evaluated. No patients in the two groups experienced in-hospital death or bypass surgery. Myocardial infarction occurred in four patients in the angioplasty group and in seven patients in the stent group (P = 0.36). No patients in either the angioplasty or the stent group had acute stent thrombosis, whereas subacute stent thrombosis occurred in only one patients of the stent group (0.9%). Long-term MACEs (20 ± 4 month) were not different in the two groups (angioplasty group 39% vs. stent group 44%, P = 0.35). Target lesion revascularization rate was 33% in the angioplasty group and 34% in the stent group (P = 0.50). Restenosis rate was not statistically different in the two groups (stent group 41% vs. angioplasty group 38%, P = 0.41). In conclusion, compared to balloon angioplasty, elective stent implantation in small vessels with complex lesions does not improve early and late outcome. Cathet. Cardiovasc. Intervent. 50:390–397, 2000. © 2000 Wiley-Liss, Inc.

Transabdominal mimially invasive direct coronary artery bypass grafting (MIDCAB)

Abstract: The major limitations of current minimally invasive direct coronary artery bypass (MIDCAB) techniques are multivessel and distal vessel disease frequently seen in patients with extensive stent restenosis ('full metal jacket syndrome') and reoperative surgery. Two separate minimal access incisions (minithoracotomy, lower partial sternotomy) have been used to bypass two separate arteries (left internal mammary artery (LIMA) to left anterior descending (LAD), right gastroepiploic artery (RGEA) to posterior descending artery (PDA)). To bypass multiple coronary arteries using multiple arterial conduits without violation of bony parts, we use a new minimal access incision by 'transabdominal approach'.

Effects of thyroplasty type I on vocal fold vibration

Abstract: Objective To ascertain effects of medialization thyroplasty on vocal fold vibration in glottic incompetence dysphonia Study Design Quantitative videostroboscopic glottic measurements and vocal function study were perioperatively undertaken in 20 patients undergoing Isshiki's thyroplasty type I Methods In digitized images, the glottal area, glottal width, posterior glottal width, and amplitude over an entire glottal cycle were measured and normalized by membranous vocal fold length The ratio of closed phase to total phase of vibratory cycle was calculated from the data of the glottal area and the glottal width at the middle point of the membranous vocal fold Well-accepted acoustic, aerodynamic, and perceptual measures analyzed vocal function Results Glottal area and glottal width were reduced after surgery While preoperative closure of glottal area was incomplete in all 20 patients, incomplete closure was obtained in 16 patients after surgery In these 16 patients, closure of glottal width at the middle point of the membranous vocal fold was complete, whereas a posterior glottal gap remained in 14 patients Closed phase over one cycle of glottal width waveform and amplitude of vocal fold vibration were increased after surgery Glottal area, glottal width, posterior glottal width, and closed phase over one cycle of glottal width waveform correlated with vocal function measures Conclusions Thyroplasty type I reduces a glottal gap and increases closed phase over one cycle and amplitude of vocal fold vibration, although a posterior glottal gap remains With the improved glottic vibration, thyroplasty type I provides more efficient phonation in patients with glottic incompetence dysphonia

Unusual infant death: dog attack or postmortem mutilation after child abuse?

Abstract: An unusual form of fatal child abuse is reported in which investigations by the police and the medical examiner were able to distinguish blunt force head trauma followed by postmortem dismemberment from a fatal dog attack. A discussion of the approaches used to ascertain the correct diagnosis is presented, as well as an overview of dog attacks on humans.

Nucleated red blood cells in growth-restricted fetuses: associations with short-term neonatal outcome.

Abstract: Objective: To determine the utility of the neonatal nucleated red blood cell (NRBC) count as an independent predictor of short-term perinatal outcome in growth-restricted fetuses. &

Experimental evaluation of a short transitional edge protection balloon for intracoronary stent deployment.

Abstract: The purpose of this study was to determine if balloon injury to the adjacent arterial wall during intracoronary stent deployment influences late in-stent neointimal formation. Stent design and deployment techniques are considered important factors in determining acute and long-term success with intracoronary stenting. Experimental and clinical studies support that the extent of neointimal formation and the probability for restenosis are influenced by the magnitude of arterial trauma induced with stenting. Nineteen 18-mm-long balloon-expandable stainless steel stents (MULTI-LINK Duet) were implanted at a 1:1 stent-to-artery ratio in the coronary arteries of swine with a conventional noncompliant balloon (n = 10) or a novel noncompliant balloon with short tapered shoulders to prevent edge dissection (n = 9). Quantitative coronary angiography and histology were used to evaluate balloon and artery interactions and the chronic vascular responses to the stents. Nineteen stents were implanted in the coronary arteries of seven swines at an inflation pressure of 14 atm using a standard noncompliant (n = 10) or a unique short transitional edge protection (n = 9) balloon. Histologic analysis at 28 days demonstrated balloon-associated barotrauma in 13 of 20 (65%) of adjacent nonstented arterial segments with the conventional balloon and only 3 of 18 (17%) of the adjacent nonstented arterial segments with the short transition edge protection balloon (P = 0.022). In-stent neointimal area and % stenosis correlated with the severity of peristent arterial injury (r = 0.43, P = 0.01). In-stent vessel injury scores were similar for stents with peristent injury (1.0 ± 0.3) versus stents without peristent injury (1.0 ± 0.03, P = 0.73). In-stent neointimal area and % stenosis were greater for stents with peristent injury (2.36 ± 0.74 mm 2 , 32% ± 9%) as compared to stents without peristent injury (1.39 ± 0.70 mm 2 , 20% ± 10%, P = 0.01). Arterial wall injury adjacent to a stent after high-pressure deployment contributes to late in-stent neointimal hyperplasia in this model. These experimental data suggest that further study is warranted to refine stent implantation techniques and that modifications of balloon shape or material may be useful to optimize stent deployment and reduce arterial trauma.