SAGES masters program: the top 10 seminal articles for the laparoscopic left and sigmoid colectomy pathway for complex disease.

BACKGROUND: The SAGES University Colorectal Masters Program is a structured educational curriculum that is designed to aid practicing surgeons develop and maintain knowledge and technical skills for laparoscopic colorectal surgery. The Colorectal Pathway is based on three anchoring procedures (laparoscopic right colectomy, laparoscopic left and sigmoid colectomy for uncomplicated and complex disease, and intracorporeal anastomosis for minimally invasive right colectomy) corresponding to three levels of performance (competency, proficiency and mastery). This manuscript presents focused summaries of the top 10 seminal articles selected for laparoscopic left and sigmoid colectomy for complex benign and malignant disease. METHODS: A systematic literature search of Web of Science for the most cited articles on the topic of laparoscopic complex left/sigmoid colectomy yielded 30 citations. These articles were reviewed and ranked by the SAGES Colorectal Task Force and invited subject experts according to their citation index. The top 10 ranked articles were then reviewed and summarized, with emphasis on relevance and impact in the field, study findings, strength and limitations and conclusions. RESULTS: The top 10 seminal articles selected for the laparoscopic left/sigmoid colectomy for complex disease anchoring procedure include advanced procedures such as minimally invasive splenic flexure mobilization techniques, laparoscopic surgery for complicated and/or diverticulitis, splenic flexure tumors, complete mesocolic excision, and other techniques (e.g., Deloyers or colonic transposition in cases with limited colonic reach after extended left-sided resection). CONCLUSIONS: The SAGES Colorectal Masters Program top 10 seminal articles selected for laparoscopic left and sigmoid colectomy for complex benign and malignant disease anchoring procedure are presented. These procedures were the most essential in the armamentarium of practicing surgeons that perform minimally invasive surgery for complex left and sigmoid colon pathology.

Detection of Newly Secreted Antibodies Predicts Nonrecurrence in Primary Clostridioides difficile Infection.

Within 8 weeks of primary Clostridioides difficile infection (CDI), as many as 30% of patients develop recurrent disease with the associated risks of multiple relapses, morbidity, and economic burden. There are no clear clinical correlates or validated biomarkers that can predict recurrence during primary infection. This study demonstrated the potential of a simple test for identifying hospitalized CDI patients at low risk for disease recurrence. Forty-six hospitalized CDI patients were enrolled at Emory University Hospitals. Samples of serum and a novel matrix from circulating plasmablasts called "medium-enriched for newly synthesized antibodies" (MENSA) were collected during weeks 1, 2, and 4. Antibodies specific for 10 C. difficile antigens were measured in each sample. Among the 46 C. difficile-infected patients, 9 (19.5%) experienced recurrence within 8 weeks of primary infection. Among the 37 nonrecurrent patients, 23 (62%; 23/37) had anti-C. difficile MENSA antibodies specific for any of the three toxin antigens: TcdB-CROP, TcdBvir-CROP, and/or CDTb. Positive MENSA responses occurred early (within the first 12 days post-symptom onset), including six patients who never seroconverted. A similar trend was observed in serum responses, but they peaked later and identified fewer patients (51%; 19/37). In contrast, none (0%; 0/9) of the patients who subsequently recurred after hospitalization produced antibodies specific for any of the three C. difficile toxin antigens. Thus, patients with a negative early MENSA response against all three C. difficile toxin antigens had a 19-fold greater relative risk of recurrence. MENSA and serum levels of immunoglobulin A (IgA) and/or IgG antibodies for three C. difficile toxins have prognostic potential. These immunoassays measure nascent immune responses that reduce the likelihood of recurrence thereby providing a biomarker of protection from recurrent CDI. Patients who are positive by this immunoassay are unlikely to suffer a recurrence. Early identification of patients at risk for recurrence by negative MENSA creates opportunities for targeted prophylactic strategies that can reduce the incidence, cost, and morbidity due to recurrent CDI.

Development of a focal lesion phantom with clinically relevant lesion characteristics for image quality evaluation of breast ultrasound scanners.

PURPOSE: Contrast-detail (C-D) and anechoic-target (A-T) detectability are measures of an ultrasound scanner's ability to image lesions of varying contrast and size from background tissue and, as such, they are important tools for grading the imaging capabilities of ultrasound scanners. The objective of this study was to develop a range of contrast- and anechoic-detail phantoms with clinically relevant lesions, of various contrast and sizes, for performance testing of breast ultrasound equipment. METHODS: Tissue mimicking materials that represent the acoustic properties of breast fibroglandular tissue were produced and moulded to construct a range of C-D and A-T phantoms. Two phantom designs were produced, containing cylindrical and spherical targets. Both phantom types were constructed with contrast targets covering the range anechoic, -1, -2, -3 and -4 dB, with lesion diameters of 1-4 mm, positioned at four clinically relevant depths (10, 25, 40 and 55 mm). An image analysis program was developed to objectively analyse the lesion images and to determine the lesion-signal-noise-ratio (LSNR). RESULTS: Both phantoms were used to evaluate the performance of a breast ultrasound scanner. The use of cylindrical phantoms led to an artificially higher image quality performance compared with the more clinically relevant spherical lesion phantom, thus indicating the importance of using the appropriate targets in ultrasound phantoms. CONCLUSION: The spherical lesion phantoms, coupled with the quantitative metric of LSNR, provides a comprehensive approach for performance and quality control testing, as well as the evaluation of advanced ultrasound imaging modes and technologies.

Novel immunoassay for diagnosis of ongoing Clostridioides difficile infections using serum and medium enriched for newly synthesized antibodies (MENSA).

BACKGROUND: Clostridioides difficile infections (CDI) have been a challenging and increasingly serious concern in recent years. While early and accurate diagnosis is crucial, available assays have frustrating limitations. OBJECTIVE: Develop a simple, blood-based immunoassay to accurately diagnose patients suffering from active CDI. MATERIALS AND METHODS: Uninfected controls (N = 95) and CDI patients (N = 167) were recruited from Atlanta area hospitals. Blood samples were collected from patients within twelve days of a positive CDI test and processed to yield serum and PBMCs cultured to yield medium enriched for newly synthesized antibodies (MENSA). Multiplex immunoassays measured Ig responses to ten recombinant C. difficile antigens. RESULTS: Sixty-six percent of CDI patients produced measurable responses to C. difficile antigens in their serum or MENSA within twelve days of a positive CDI test. Fifty-two of the 167 CDI patients (31%) were detectable in both serum and MENSA, but 32/167 (19%) were detectable only in MENSA, and 27/167 (16%) were detectable only in serum. DISCUSSION: We describe the results of a multiplex immunoassay for the diagnosis of ongoing CDI in hospitalized patients. Our assay resolved patients into four categories: MENSA-positive only, serum-positive only, MENSA- and serum-positive, and MENSA- and serum-negative. The 30% of patients who were MENSA-positive only may be accounted for by nascent antibody secretion prior to seroconversion. Conversely, the serum-positive only subset may have been more advanced in their disease course. Immunocompromise and misdiagnosis may have contributed to the 34% of CDI patients who were not identified using MENSA or serum immunoassays. IMPORTANCE: While there was considerable overlap between patients identified through MENSA and serum, each method detected a distinctive patient group. The combined use of both MENSA and serum to detect CDI patients resulted in the greatest identification of CDI patients. Together, longitudinal analysis of MENSA and serum will provide a more accurate evaluation of successful host humoral immune responses in CDI patients.

Community Priority setting for Fetal Alcohol Spectrum Disorder Research in Australia.

INTRODUCTION: Fetal Alcohol Spectrum Disorder (FASD) is a neurodevelopmental disorder caused by prenatal alcohol exposure (PAE). FASD research is a rapidly growing field that crosses multiple disciplines. To ensure research is relevant and meaningful for people living with FASD, their families, and the broader public there is a need to engage community members in setting priorities for research. OBJECTIVES: Our primary objective was to formally identify the views of people living with FASD, their parents/caregivers, service providers, and the general community on the research priorities for FASD and alcohol use in pregnancy in Australia. Our secondary objective was to provide an overview of current research in the highest priority areas identified. METHODS: The approach for this study involved two community surveys and a consensus workshop, followed by a rapid literature review. Survey responses (n = 146) were collected and grouped using qualitative thematic analysis. The themes identified were then ranked in a second survey (n = 45). The 22 highest ranked themes were considered in a workshop with 21 community members, and consensus on the top ten priority areas was sought. The priority areas were grouped into conceptually similar topics and rapid literature reviews were undertaken on each. RESULTS: A diverse range of priorities was identified within key areas of prevention, diagnosis, and therapy. On request from participants, separate priority lists were developed by Aboriginal and non-Aboriginal participants. CONCLUSION: There is need for a national network of researchers to take forward the research commenced by the Centre of Research Excellence, FASD Research Australia, in addressing community priorities. KEY WORDS: Community, priorities, FASD, rapid review, Australia.

Prevalence of recreational drug use reported by men who have sex with men attending sexual health clinics in Manchester, UK.

Recreational drug use (RDU) has been reported to be disproportionately higher in men who have sex with men (MSM) when compared to their heterosexual counterparts. To identify RDU, links to risky sexual practices and infections for MSM attending three sexual health clinics across Manchester, United Kingdom, a retrospective case note review was conducted using a random powered sample of service users attending three sites during 2014. Three hundred and fifty-seven case notes were reviewed across three sites. Eighteen per cent of service users reported any type of RDU. Use of at least one of the three drugs associated with chemsex (crystal methamphetamine, mephedrone, gamma hydroxybutyrate/gamma butyrolactone) was reported by 3.6%. A statistically significant difference was identified between non-drug users and any-drug users reporting: group sex (odds ratio [OR] 5.88, p = 0.013), condomless receptive anal intercourse (CRAI) (OR 2.77, p = 0.003) and condomless oral intercourse (OR 2.52, p = 0.016). A statistically significant difference was identified between chemsex-related drug user and non-drug user groups reporting: group sex (OR 13.05, p = 0.023), CRAI (OR 3.69, p = 0.029) and condomless insertive anal intercourse (OR 1.27, p = 0.039). There was also a statistically higher incidence of gonorrhoea infection in chemsex-related drug use compared with those not using drugs (p = 0.002, OR 6.88). This study identifies that substance use is common in MSM attending sexual health clinics in Manchester. High-risk sexual practices and certain sexually transmitted infections are more common in MSM reporting RDU.

Assessment of the accuracy of an ultrasound elastography liver scanning system using a PVA-cryogel phantom with optimal acoustic and mechanical properties.

The accuracy of a transient elastography liver-scanning ultrasound system was assessed using a novel application of PVA-cryogel as a tissue-mimicking material with acoustic and shear elasticity properties optimized to best represent those of liver tissue. Although the liver-scanning system has been shown to offer a safer alternative for diagnosing liver cirrhosis through stiffness measurement, as compared to the liver needle biopsy exam, the scanner's accuracy has not been fully established. Young's elastic modulus values of 5-6 wt% PVA-cryogel phantoms, also containing glycerol and 0.3 µm Al(2)O(3) and 3 µm Al(2)O(3), were measured using a 'gold standard' mechanical testing technique and transient elastography. The mechanically measured values and acoustic velocities of the phantoms ranged between 1.6 and 16.1 kPa and 1540 and 1570 m s(-1), respectively, mimicking those observed in liver tissue. The values reported by the transient elastography system overestimated Young's elastic modulus values representative of the progressive stages of liver fibrosis by up to 32%. These results were attributed to the relative rather than absolute nature of the measurement arising from the single-point acoustic velocity calibration of the system, rendering the measurements critically dependent on the speed of sound of the sample under investigation. Given the wide range of acoustic velocities which exist in the liver, spanning healthy tissue to cirrhotic pathology, coupled with the system's assumption that the liver is approximately elastic when it is rather highly viscoelastic, care should be exercised when interpreting the results from this system in patient groups.

The effect of pre-operative counselling on smoking patterns in patients undergoing forefoot surgery.

BACKGROUND: Smoking contributes to higher surgical complication rates. Previous studies assessing smoking cessation interventions examined the provision of comprehensive packages. The use of surgery as an incentive to complement brief advice has not been fully evaluated. METHODS: Smokers were counselled and referred to their general practitioners for specific cessation strategies. Smoking status was recorded prior to surgery, on admission and in post-operative clinics. A telephone survey at a mean of 12 months post-operation ascertained long-term behavioural changes. RESULTS: Ninety-seven patients underwent surgery with twenty-five recorded as smokers. Sixteen stopped smoking pre-operatively; a further four reduced their intake, as a direct consequence of counselling. No patients were previously aware of the detrimental effects of smoking associated with foot surgery. CONCLUSIONS: Surgery provides an incentive for smoking cessation, maintained post-operatively. Although forefoot fusions and arthrodeses were used in our study, the results are transferable to other branches of orthopaedic surgery.

The use of post-operative reverse camber shoes following scarf osteotomy.

BACKGROUND: Reverse camber shoes are a popular choice for immobilization following scarf osteotomy. There are no reports in the literature giving guidance on the duration of shoe use. METHODS: Seventy-eight patients were reviewed. All had been advised to remain in reverse camber shoes until point of radiographic follow up. Data regarding time spent in shoes, associated adverse symptoms of shoes, and complications were recorded. RESULTS: Three groups emerged. Group 1 (65 patients) wore the shoes for the instructed period of time. Group 2 (six patients) were those who removed the shoes early. Group 3 (seven patients) were those who wore the shoes following review. There were no differences in complication rates between the groups. CONCLUSION: The use of post-op shoes is for symptom control. Our practice now is to advise patients to wear their shoes for as long as they feel necessary rather than giving them a prescriptive time limit.

First recanalization of a coronary artery chronic total obstruction in an 11-year-old child with Kawasaki disease sequelae using the CROSSER catheter.

This is a case of an 11(1/2)-year-old diagnosed with Kawasaki disease at 6 months of age. Distal left main coronary aneurysm involving the proximal anterior descending and circumflex had progressed into a chronic total occlusion. We report the first application of a novel percutaneous technique using the CROSSER catheter system in a child. The CROSSER is a high-frequency mechanical vibration catheter-based technology developed to safely penetrate through calcific and noncalcific coronary artery occlusions. This is also the first Kawasaki disease patient to benefit from this technology; in this disease, coronary artery stenosis is typically associated with heavy calcification.

The StarClose Vascular Closure System: interventional results from the CLIP study.

BACKGROUND: The StarClose Vascular Closure System is a femoral access site closure technology that uses a flexible nitinol clip to complete a circumferential, extravascular arteriotomy close. The Clip CLosure In Percutaneous Procedures study was initiated to study the safety and efficacy of the StarClose device in subjects undergoing diagnostic and interventional catheterization procedures. METHODS: A total of 17 U.S. sites enrolled 596 subjects, with 483 subjects randomized at a 2:1 ratio to receive StarClose or standard compression of the arteriotomy after the percutaneous procedure. The study included roll-in (n = 113), diagnostic (n = 208), and interventional (n = 275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis. RESULTS: The results of the diagnostic StarClose cohort have been reported separately. Results for the interventional arm revealed major vascular complications occurring in 1.1% of StarClose subjects (2/184) and 1.1% in manual compression subjects (1/91; P = 1.00). No infections were seen in either cohort. Minor complications in the StarClose interventional group occurred at a rate of 4.3% (8/184) and with compression at 9.9% (9/91; P = 0.107). Pseudoaneurysm or arteriovenous fistula was not seen with StarClose. With StarClose, procedural success was 100% (136/136) for the diagnostic group and 98.9% (181/183) in the interventional group. Device success for the treatment group was 86.8%. In the interventional cohort, 87.3% (158/181) of StarClose subjects reported a pain scale of 0-3 compared with 93.3% (84/90) in the compression group, which was not statistically different. CONCLUSIONS: The clinical results of this study demonstrate that the StarClose Vascular Closure System is noninferior to manual compression with respect to the primary safety endpoint of major vascular events in subjects who undergo percutaneous interventional procedures. StarClose significantly reduced time to hemostasis, ambulation, and dischargeability when compared with compression.

The safety and efficacy of the StarClose Vascular Closure System: the ultrasound substudy of the CLIP study.

BACKGROUND: The StarClose Vascular Closure System (Abbott Vascular, Redwood City, CA) features a nitinol clip that is designed to achieve closure of the femoral arteriotomy access site. The CLIP Study was performed to assess the safety and efficacy of StarClose when compared with standard manual compression following 5-6 French diagnostic or interventional percutaneous procedures. A substudy of this trial was designed to assess the utility of duplex ultrasonography to assess patency of the femoral artery and to determine access site complications (pseudoaneurysm, arteriovenous fistula, hematoma, deep vein thrombosis) in a multicenter prospective trial. This is the report of the duplex ultrasound (DUS) substudy of the CLIP trial. METHODS: A total of 17 U.S. sites enrolled 596 subjects with 483 subjects randomized at a 2:1 ratio to receive StarClose or manual compression of the arteriotomy after a percutaneous procedure. The study included roll-in (n = 113), diagnostic (n = 208), and interventional (n = 275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis. A substudy of the CLIP interventional arm evaluated DUS images of the closure site at five study sites, targeting 100 subjects at day 30 following hemostasis. The DUS protocol was devised and implemented by an independent vascular ultrasound core laboratory with extensive experience in vascular device trials. DUS inguinal region from 6 cm proximal to 6 cm distal to the arteriotomy puncture was performed. A qualitative examination was performed to determine the presence of iatrogenic vascular injuries: hematoma, pseudoaneurysm (PSA), arteriovenous fistula (AVF), and arterial/venous thrombosis or stenosis using 2-dimensional gray scale, color, and focused Doppler images. RESULTS: DUS of 96 subjects randomized to StarClose (n = 71) and compression (n = 25) were performed and evaluated. There was no evidence of hematoma, PSA, or AVF observed in the StarClose group. No StarClose subjects in the substudy had a PSA or AVF. All patients in the substudy demonstrated patency of the access site artery and vein without thrombosis or stenosis. Finally, in the entire study cohort, no clinically-driven DUS studies demonstrated iatrogenic vascular injury or vessel thrombosis in the StarClose treated patients. CONCLUSION: DUS, a safe and reliable method for determining the safety and efficacy of access site closure devices, is a reliable, safe, inexpensive and accurate method of assessing vascular access site complications in multicenter trials. In this substudy of the CLIP study, DUS found no statistical difference in access site complications between the StarClose and manual compression groups. Both groups maintained vessel patency without stenosis, thrombosis, hematoma, pseudoaneurysm, or AV fistula.

Operative shortening of the elongated defunctioned tendoachillies following previous rupture.

Healing of the tendoachilles (TA) following rupture may result in lengthening over a long segment rather than discrete scar interposition. We describe our experience and results of a direct TA shortening technique of dysfunctionally long TAs. Five patients presented with impairment of their sporting level. Four patients had TA injuries that were managed by physiotherapy alone and 1 had been cast immobilised for 6 weeks. At open operation the TAs were found to be confluent but with evidence of scarring over a long segment. A 'Z' shortening was performed. The patients were reviewed up to a mean of 30 months post op. The overall scores were excellent in 1, good in 3 and fair in 1. All returned to their chosen level of sporting activity. The technique described is relatively straightforward and gives predictable improvement in function. It is therefore a useful technique in this often-unrecognised condition

Outcome prediction model for very elderly critically ill patients.

CONTEXT: Very elderly critically ill patients have three possible hospital outcomes: discharge to home, discharge to a skilled nursing or rehabilitation facility, or death. The factors associated with these outcomes are unknown. OBJECTIVE: To develop a three-outcome prediction model for very elderly critically ill patients. DESIGN: Retrospective chart abstraction with ordered logistic regression analysis. SETTING: Academic medical center. PATIENTS: Four hundred and fifty-five patients 85 yrs or older admitted to intensive care units (ICU) during 1996 and 1997. MEASUREMENTS AND MAIN RESULTS: A fitted ordinal logistic regression predictive model was developed using data from 243 patients hospitalized in 1996, and validated on data from 212 patients hospitalized in 1997. Model variables include age, gender, baseline support level, type of ICU, heart rate at ICU admission, use of mechanical ventilation, vasopressors or a pulmonary artery catheter during the ICU stay, and the development of respiratory, neurologic or hematologic failure or sepsis while in the ICU. When tested on the 1997 data, the model was well calibrated and had a high discriminant index. CONCLUSIONS: This mathematical model can be used to predict the risks of these three hospital outcomes for this population of patients. These predictions can provide a context when discussing goals and expectations with patients, families, and other healthcare providers and to aid in hospital discharge planning.

Fluid accumulation and the rapid spread of bacteria in the pathogenesis of external fixator pin track infection.

An animal model was used to study the pathogenesis of pin track infection. The roles of fluid accumulation around the pin/bone interface and mechanical loosening of the pin were specifically studied. In addition, the spread of bacteria in relation to the clinical appearance of the pin track was assessed. This study demonstrated that fluid accumulation around the interface is an important factor in the spread of infection from the superficial wound track to the medulla of the bone. Spread occurs despite the absence of mechanical pin loosening, and can occur before any clinical features of infection are apparent.

Therapeutic ultrasound for chronic total coronary artery occlusions.

This article focuses on the use of catheter-delivered ultrasound as a device for treatment of coronary arterial total occlusion (CTO). The standard treatment of CTO is reviewed and serves as the basis for the need for new treatment options, such as catheter-delivered ultrasound (SONICROSS). The results of FDA-approved Phase I and Phase II clinical trials using SONICROSS for refractory CTO are described. The Phase II trials indicate that the SONICROSS-facilitated guidewire passage in 71% of CTOs are otherwise refractory to guidewire passage. However, at present, the SONICROSS catheter system is limited in its ability to be delivered reliably to the CTO because of catheter size and trackability.

Behind armour blunt trauma--an emerging problem.

Behind Armour Blunt Trauma (BABT) is the non-penetrating injury resulting from the rapid deformation of armours covering the body. The deformation of the surface of an armour in contact with the body wall arises from the impact of a bullet or other projectile on its front face. The deformation is part of the retardation and energy absorbing process that captures the projectile. In extreme circumstances, the BABT may result in death, even though the projectile has not perforated the armour. An escalation of the available energy of bullets and the desire of armour designers to minimise the weight and bulk of personal armour systems will increase the risk of BABT in military and security forces personnel. In order to develop materials that can be interposed between the armour and the body wall to attenuate the transfer of energy into the body, it is essential that the mechanism of BABT is known. There is a great deal of activity within UK and NATO to unravel the interactions; the mechanism is likely to be a combination of stress (pressure) waves generated by the rapid initial motion of the rear of the armour, and shear deformation to viscera produced by gross deflection of the body wall. Physical and computer model systems are under development to characterise the biophysical processes and provide performance targets for materials to be placed between armours and the body wall in order to attenuate the injuries (trauma attenuating backings-TABs). The patho-physiological consequences of BABT are being clarified by research, but the injuries will have some of the features of blunt chest trauma observed in road traffic accidents and other forms of civilian blunt impact injury. The injuries also have characteristics of primary blast injury. An overview diagnosis and treatment is described.

Anterior tibiotalar impingement associated with chronic ankle instability.

The authors describe the surgical treatment of 13 cases of chronic ankle instability and concomitant anterior bony impingement of the ankle in professional and recreational athletes. All patients had symptoms and signs of lateral instability and a painful block to dorsiflexion. Two patients presented with recurrence of impingement after a previous debridement alone without an ankle stabilization. The anterior osteophytes were debrided arthroscopically and a Brostrom-Gould open stabilization was performed. After a mean follow-up period of 12 months (range 4-23 months), all 13 patients had mechanically and functionally stable ankles. The mean improvement in range of dorsiflexion was 12.4 degrees and all but one had improvement with respect to a subjective and functional outcome assessment. There have been no recurrences of impingement to date. These results suggest that ankle stabilization performed in conjunction with debridement of osteophytes may reduce the recurrence of exostoses as well as improving the outcome.

Acute MI. Age-related presentations and treatment options.

At least 60% of all acute myocardial infarctions (AMIs) occur in patients age 65 and older and about one-third in patients older than age 75. The presentation of AMI is modified by age-related changes in endothelial function, smooth muscle cell activity, diastolic function, and responses to circulating catecholamines. Atypical presentations are common in the older patient and require the physician to maintain a high index of suspicion for AMI. ECG findings of ST-segment depression make many older patients ineligible for reperfusion by thrombolytic therapy. Acute and post-MI medical therapies are underused in the older population and should be individualized, based on the presence of comorbid conditions.

Directional coronary atherectomy in intermediate sized vessels: final results of the intermediate vessel atherectomy trial (IVAT).

Revascularization options for intermediate sized vessels (2.5-2.9 mm) have historically been limited. IVAT is a pilot study to assess the efficacy and safety of debulking intermediate sized vessels using directional coronary atherectomy (DCA). Between March 1996 and June 1997, 50 patients were enrolled at seven hospitals in the United States. Of those patients, 70% presented with unstable angina and 52% had single vessel disease. Of the lesions treated, 96% were de novo. Adjunctive PTCA after DCA was performed in 90% of cases at the discretion of the investigator to maximize luminal diameter. The GTO DCA device was used in 90% of cases. Procedural success (residual stenosis <50% without major complications) was 94%. Stents were placed in 12% of patients. The only complications were three non-Q wave MIs. Mean reference vessel diameter increased from 2.49 mm pre-procedure to 2.57 mm after DCA and 2.61 post-procedure; mean MLD increased from 0.76 mm to 2.03 mm to 2.31 mm; and mean stenosis decreased from 70% to 21% post DCA and to 11% post procedure. At six months follow-up, 18.0% of target lesions required revascularization. Total revascularization, including non-target vessels, was 32%. These results suggest that DCA has a high procedural success rate and a low target lesion revascularization rate in intermediate sized vessels.