[Argentinean consensus guidelines on the use of monoclonal antibodies in patients with migraine]. / Consenso sobre el uso de anticuerpos monoclonales en la migraña en Argentina.

INTRODUCTION: Migraine is a very prevalent disorder that is estimated to affect about 15% of adult subjects. Recently, the efficacy and safety of monoclonal antibodies that act on the calcitonin gene-related peptide pathway (MA-CGRP) has been evaluated in migraine. Several groups around the world have developed consensus guidelines about the use of monoclonal antibodies, however, in some regions is difficult to extrapolate the recommendations. AIM: To provide recommendations for the use of MA-CGRP in migraine in Argentina. DEVELOPMENT: A group of neurology experts from Argentina, by using the online surveys methodology as well as face to face meetings developed the intended consensus for the use of MA-CGRP in migraine in Argentina. Recommendations were established based on published evidence and the expert opinion. Recommendations focused on how, when, treatment duration and patients follow up. CONCLUSION: The recommendations of this consensus guidelines attempt to optimize the use of MA-CGRP in migraine in Argentina.

TITLE: Consenso sobre el uso de anticuerpos monoclonales en la migraña en Argentina.Introducción. La migraña es un trastorno muy prevalente que se estima que afecta a alrededor del 15% de los sujetos adultos. Durante los últimos años, se ha evaluado la eficacia y la seguridad de los anticuerpos monoclonales que actúan sobre la vía del péptido relacionado con el gen de la calcitonina (AM-PRGC) en la migraña. Diversos grupos de trabajo internacionales han intentado clarificar y normatizar el uso de estos medicamentos en la migraña. Sin embargo, en muchas ocasiones se extrapolan datos de otras regiones que no contemplan la realidad de cada lugar o son difíciles de implementar. Objetivo. Proveer recomendaciones sobre el uso de AM-PRGC en pacientes con migraña en Argentina. Desarrollo. Un grupo de expertos de Argentina conformado por neurólogos, mediante metodología de ronda de encuestas en la distancia y reuniones presenciales, llevó adelante la elaboración del consenso pretendido para el uso de AM-PRGC en pacientes con migraña en Argentina. Se establecieron las recomendaciones basadas en la evidencia publicada y en el criterio de los expertos que participaron. Las recomendaciones se enfocaron en el momento de usar los AM-PRGC en la migraña tanto crónica como episódica, la duración, los cuidados y el entorno para hacerlo. Conclusión. Las recomendaciones establecidas en el presente consenso permitirán optimizar el manejo de los AM-PRGC en pacientes con migraña en Argentina.

Risk stratification and outcomes of transluminal endografting for abdominal aortic aneurysm: 7-year experience and long-term follow-up.

PURPOSE: To determine early and late outcomes of transluminal endografting (TE) in patients with abdominal aortic aneurysm (AAA), stratified by predicted risk of procedure-related mortality with conventional operation. MATERIALS AND METHODS: A retrospective study was conducted in consecutive risk-stratified AAA patients undergoing TE at a not-for-profit cardiovascular referral center from March 1994 through November 2000 with follow-up through February 2001. With use of conventional risk strata (0 = low, 1 = minimal, 2 = moderate, and 3 = high), predicted procedure-related mortalities were 0%-1% in stratum 0 (n = 40), 1%-3% in stratum 1 (n = 118), 3%-8% in stratum 2 (n = 116), and 8%-30% in stratum 3 (n = 31). Main outcome measures were: (i) TE procedural success, (ii) procedure-related mortality, (iii) major nonfatal complications, (iv) composite adverse outcome (ii + iii), (v) length of stay (LOS), (vi) freedom from AAA rupture, (vii) late survival, (viii) late complications, and (ix) endoleaks and their classification and management. RESULTS: Women were significantly less likely than men to qualify for and undergo endografting: 24 of 91 (26.4%) women underwent TE, compared to 281 of 684 (41.1%) men. Of 305 attempted TE procedures, 291 (95.4%) were successful, four (1.3%) were urgently converted to open repair, and 10 (3.3%) were aborted. Procedure-related mortalities occurred in eight cases (2.6%) overall and one of 40 (2.5%), one of 118 (0.8%), four of 116 (3.4%), and two of 31 (6.5%) cases for risk strata 0-3, respectively. Perioperative survivors were significantly younger than nonsurvivors (74.3 y +/- 9 vs 81.6 y +/- 5.1; P =.0087). Forty-six patients (15.1%) had major complications. Composite adverse outcome was worse for patients in stratum 3 than those in stratum 1 (P =.0296) and those in strata 0, 1, and 2 combined (P =.026). Procedure-related mortality declined with institutional experience, from 4% among the first 100 patients undergoing TE to 1% among the last 105. For strata 0-3, median LOS were 2, 3, 3, and 4 days, respectively. Seventy patients (22.9%) had 75 endoleaks, of which 30 necessitated additional procedures, 17 self-resolved, and 22 were untreated as of March 1, 2001. Five patients with endoleak died of unrelated causes. One late-onset type IA endoleak (26 mo) resulted in the only AAA rupture and death in the follow-up period among the 291 patients who underwent successful transluminal endograft implantation. Actuarial survival rates at 1 year after TE were 90.3% +/- 1.9% for the overall study group and 97.5% +/- 2.5%, 94% +/- 2.5%, 86.9% +/- 3.3%, and 81.3% +/- 7.7% for risk strata 0-3, respectively. At 5 years, overall actuarial survival was 69.6% +/- 6.1%. Thirty-eight late deaths were attributable to post-TE AAA rupture (n = 1), AAA rupture late after failed TE with no further treatment (n = 1), other cardiovascular disorders (n = 7), cancer (n = 15), other causes (n = 10), and unknown causes (n = 4). Late deaths occurred in risk strata 0-3 at the following rates: two of 40 (5%), 10 of 118 (8.5%), 16 of 116 (13.8%), and 10 of 31 (32.3%), respectively (stratum 0 vs stratum 3, P =.0017; stratum 1 vs stratum 3, P =.003). CONCLUSIONS: TE is safe and confers durable protection against AAA rupture in treated populations. Still, protection is not absolute in patients with endoleaks, because late AAA enlargement and even rupture can occur. Given current knowledge, technology, and practice, careful patient selection and close surveillance of patients after implantation of transluminal endografts is essential.

Idiopathic pedunculated mural thrombus of the nonaneurysmal infrarenal aorta presenting with popliteal embolization: two cases treated with thrombolytic therapy.

The source of emboli to large or medium sized arteries is most commonly the heart; occasionally, it is an aortic aneurysm. The unusual embolic source of aortic mural thrombus in an otherwise minimally diseased aorta has been infrequently reported, and the etiology and management of this entity are not well defined. We describe two cases of infrarenal aortic mural thrombus treated with thrombolytic therapy and review the published experience with this entity.

Five-step protocol for carotid endarterectomy in the managed health care era.

BACKGROUND: We developed a protocol combining 5 cost-effective strategies to determine whether elective carotid endarterectomy (CEA) could be performed safely without adversely affecting well-established low morbidity and mortality rates and with significant hospital cost savings. METHODS: Between April 1, 1995, and December 31, 1996, 109 of 141 patients were prospectively enrolled as candidates into a 5-step CEA protocol: (1) duplex ultrasonography (DU) performed at an accredited vascular laboratory as the sole diagnostic carotid preoperative study, (2) admission the day of operation, (3) cervical block anesthesia to eliminate intraoperative electroencephalogram monitoring, (4) transfer from the recovery room after a 4-hour observation period to the vascular ward, and (5) discharge the first postoperative morning. The other 32 patients were excluded from analysis; 16 patients were treated by vascular surgeons not participating in the protocol, 9 were treated concomitantly for other medical problems, and 7 were admitted emergently. RESULTS: One patient died of carotid hemorrhage the first postoperative morning, and one had an intraoperative embolic stroke for a combined mortality-stroke rate of 1.8% (2 of 109). Of the 109 patients, 70% (76) underwent operation using DU as the sole diagnostic study, 95% (104) were admitted the day of operation, 76% (83) had cervical block anesthesia, 59% (64) were transferred to the floor the day of operation, and 83% (90) were discharged the morning after operation. None of the 109 patients were adversely affected by these 5 cost-saving strategies except potentially the patient who bled the first postoperative morning. The predicted charges of a patient treated with a perioperative protocol that many vascular surgeons currently use (preoperative arteriography, general anesthesia with intraoperative electroencephalogram monitoring, overnight intensive care unit stay, discharge on postoperative day 2) was $16,073 compared with $10,437 for a patient who completed all 5 steps of the protocol detailed above. CONCLUSIONS: On the basis of these results documenting significant cost savings and acceptably low morbidity and mortality rates, this 5-step protocol may be considered the standard for performing CEA in this era of cost containment. These results may be compared with endovascular intervention, which has recently been proposed as a less expensive technique to treat carotid disease.

Is balloon angioplasty indicated for "short" stenoses of failing vein grafts?

Previous reports have suggested "short" focal stenoses in peripheral vein grafts (PVGs), namely less than 2 cm long, can be successfully balloon dilated with good long-term patency rates. We questioned if enthusiasm for balloon angioplasty of these lesions in failing PVGs is warranted. Between August 1, 1993 and December 31, 1996, we performed balloon angioplasty of "short" stenoses in 19 PVGs in 16 patients. Bypasses included seven femoropopliteal, six femorotibial, and six popliteal-tibial or -pedal PVGs. All bypasses were originally performed for limb salvage. Single lesions were present in 13 grafts and two lesions in six grafts. Ten lesions were located at an anastomosis, 10 were located in the body of the graft, and five were peri-anastomotic. Fifteen procedures were performed percutaneously. Four angioplasties were performed using an open surgical approach because a percutaneous attempt failed in one case and three grafts were either in situ or tunneled subcutaneously making them easy to expose. Completion arteriogram documented excellent initial results in all 19 grafts. Cumulative one-year primary patency rate was 39%. The assisted primary patency rate at one year was 73%. Only five grafts remained patent 7-20 months (mean, 10 months) during follow-up without requiring further revision. One patient died with a patent graft 23 months post-balloon angioplasty. Complications included two hematomas following a percutaneous approach that required surgical repair. These results when compared to publications detailing patency following surgical revision suggest that balloon angioplasty of "short" stenoses less than 2 cm long in PVGs may be better treated by surgical revision. We reserve balloon angioplasty for "short" lesions when surgical revision is associated with inordinate difficulty such as a scarred groin wound in an obese patient.

Do distal arteriovenous fistulae improve patency rates of prosthetic infrapopliteal arterial bypasses?

We retrospectively analyzed if distal anastomotic adjunctive arteriovenous fistulae (AVF) improved patency rates of prosthetic bypasses to infrapopliteal arteries. Between July 1, 1991 and June 30, 1996, we performed 43 polytetrafluoroethylene (PTFE) bypasses to infrapopliteal (19 peroneal, 13 anterior tibial, 11 posterior tibial) arteries. All bypasses were performed for limb salvage when autologous vein was not available for a conduit. Adjunctive AVFs were performed in 21 bypasses (PTFE-AVF) and 22 bypasses did not have a fistula (PTFE-ONLY). Patients were allocated to the PTFE-AVF or PTFE-ONLY groups at the discretion of the surgeons, with adjunctive AVFs being performed for small arteries with poor run-off. There were no significant differences in age, sex, site of the proximal anastomosis, or indication for surgery (p > 0.05). There were statistically significant differences in the site of distal anastomosis and quality of arterial run-off based on the Society for Vascular Surgery Ad Hoc Committee on Reporting Standards criteria (p < 0.05). All patients were placed on heparin 500 units/hour postoperatively, maintained on life-long Coumadin and followed every 3 months with duplex ultrasonography to assess graft patency. Aggressive intervention was carried out for failing grafts suspected by duplex scanning. The hospital mortality rate was 2.3% (1/43; 1 PTFE-AVF). Two-year primary patency rates were significantly better for PTFE-AVF grafts than for PTFE-ONLY grafts (23% versus 5%) (p = 0.04). Although statistical significance was not reached, there was a suggestion of higher assisted primary (34% versus 15%) (p > 0.05) and secondary (61% versus 48%) (p > 0.05) patency rates in the PTFE-AVF group versus the PTFE-ONLY group, although limb salvage rates were similar (74% versus 71%) (p > 0.05). Two AVFs required ligation because of steal resulting in diminished distal perfusion. These results support the use of adjunctive distal AVFs to improve overall two-year patency rates of prosthetic infrapopliteal arterial bypasses.

Selective use of duplex ultrasound to replace preoperative arteriography for failing arterial vein grafts.

PURPOSE: In an effort to minimize costs and patient discomfort, we determined whether duplex ultrasound (DU) could selectively replace preoperative arteriography performed in the radiology suite to diagnose failing arterial bypass grafts (FABs) constructed of autogenous vein. METHODS: Between January 1, 1994, and December 31, 1996, we treated 106 FABs. Graft revision solely on the basis of DU was performed only if a focal stenosis was clearly identified in the graft (peak systolic velocity [PSV] > 300 cm/sec, ratio of adjacent PSVs > 3.0) or in inflow or outflow arteries (resulting in uniform graft PSVs < 45 cm/sec). Intraoperative arteriograms were frequently obtained to confirm DU findings. Preoperative arteriograms were obtained if DU revealed multiple or ill-defined stenoses, diffuse inflow or outflow arterial disease, uniformly low PSVs without an identifiable lesion, or equivocal stenosis despite clinical evidence of an FAB. RESULTS: Seventy-three (69%) FABs with 81 lesions were revised on the basis of DU only. Of 76 stenotic lesions, an intraoperative arteriogram or surgical findings confirmed a diameter stenosis of 75% to 99% in 69 grafts (91%) and stenosis of 50% to 74% in three grafts (4%). DU incorrectly identified the site of stenosis or underdiagnosed the extent of disease in four grafts (5%). DU correctly identified the site of missed arteriovenous fistulas in five grafts. The 73 FABs were treated with intraoperative balloon angioplasty (30 grafts), patch angioplasty (20), interposition or jump grafts (12), ligation of arteriovenous fistula (3), a new bypass graft (1), or a combination of these interventions (7). A significant change in intraoperative strategy potentially could have been avoided if a preoperative arteriogram had been obtained in three of the 73 FABs (4.1%). CONCLUSIONS: DU can reliably be used to revise FABs and avoid the morbidity, discomfort, and cost of confirmatory arteriography in two thirds of cases.

Use of arm and lesser saphenous vein compared with prosthetic grafts for infrapopliteal arterial bypass: are they worth the effort?

PURPOSE: Arm and lesser saphenous veins (ALSVs) are generally considered to be the best alternative for infrapopliteal arterial bypass grafts when greater saphenous vein is not available. The need for additional incisions and repositioning of the patient, along with occasional use of general anesthesia for arm vein harvesting, led to our perception that the use of ALSVs increased operative time and possibly patient discomfort. Therefore, we compared the outcome of ALSVs with that of prosthetic infrapopliteal arterial bypass procedures performed at our hospital. METHODS: Between July 1, 1991, and Dec. 31, 1996, we performed 96 infrapopliteal arterial bypass procedures using 45 ALSVs (28 arm vein, 17 lesser saphenous) and 51 polytetrafluoroethylene (PTFE) grafts. Seventy grafts were single-length ALSV or PTFE bypass grafts, and 26 grafts were placed as the distal segment of a sequential or composite bypass graft. Every attempt was made to use ALSV and avoid the use of PTFE, even if a short segment of the vein graft measured less than 4.0 mm in diameter. There were no significant differences between patients with ALSV compared with PTFE grafts in terms of age, sex, indication for surgery, or number of previous revascularization procedures (2.1 vs 1.7), respectively (p > 0.05). However, ALSV grafts had more factors associated with an expected worse outcome: they were more commonly anastomosed to pedal arteries (17% [8 of 45] vs 0%; p = 0.0009), less commonly single-segment grafts (62% [28 of 45] vs 82% [42 of 51]; p = 0.03), had higher average runoff resistance values (2.3 vs 1.5; p = 0.001), and were less frequently treated with lifelong warfarin (65% [29 of 45] vs 95% [48 of 51]; p = 0.0001). RESULTS: The hospital mortality rate was 3.1% (3 of 96; 3 PTFE). All deaths were cardiac-related. Despite the potential factors associated with worse patency rates for ALSVs, 2-year assisted primary patency rates tended to be higher for arm veins (46%) than for lesser saphenous veins (23%) and PTFE grafts (26%), although this difference was not statistically significant. Limb salvage rates were similar between ALSV and PTFE grafts (76% vs 71%, respectively). The average operative time was significantly longer for ALSV bypass procedures (mean, 6.2 hours) than for PTFE bypass procedures (mean, 4.9 hours; p = 0.003), and for single-length conduits when revision of previously placed grafts was not attempted, the operative time was 4.0 hours for ALSV grafts and 2.5 hours for PTFE grafts. CONCLUSION: In our experience ALSV bypass grafts to infrapopliteal arteries do not function as well as reported by some others. In spite of the extra effort involved, arm vein grafts are preferred over PTFE grafts for their likely higher assisted primary patency rates and equivalent, if not better, limb salvage rates.