The State of the Absorb Bioresorbable Scaffold: Consensus From an Expert Panel.

Significant progress has been made in the percutaneous coronary intervention technique from the days of balloon angioplasty to modern-day metallic drug-eluting stents (DES). Although metallic stents solve a temporary problem of acute recoil following balloon angioplasty, they leave behind a permanent problem implicated in very late events (in addition to neoatherosclerosis). BRS were developed as a potential solution to this permanent problem, but the promise of these devices has been tempered by clinical trials showing increased risk of safety outcomes, both early and late. This is not too dissimilar to the challenges seen with first-generation DES in which refinement of deployment technique, prolongation of dual antiplatelet therapy, and technical iteration mitigated excess risk of very late stent thrombosis, making DES the treatment of choice for coronary artery disease. This white paper discusses the factors potentially implicated in the excess risks, including the scaffold consideration and deployment technique, and outlines patient and lesion selection, implantation technique, and dual antiplatelet therapy considerations to potentially mitigate this excess risk with the first-generation thick strut Absorb scaffold (Abbott Vascular, Abbott Park, Illinois). It remains to be seen whether these considerations together with technical iterations will ultimately close the gap between scaffolds and metal stents for short-term events while at the same time preserving options for future revascularization once the scaffold bioresorbs.

Effects of Percutaneous Transluminal Angioplasty on Diastolic Function in Patients With Chronic Occlusion of Lower-Extremity Artery.

OBJECTIVE: We investigated whether successful revascularization of total occlusion of a large lower-extremity artery is associated with improvement of left ventricular (LV) diastolic function. BACKGROUND: Total occlusion of a large lower-extremity artery might affect the systemic vascular resistance and increase the afterload, because the left ventricle must work harder to eject blood into a smaller vascular bed. Chronic elevation of afterload is a cause of LV diastolic dysfunction. METHODS: This is a single-center retrospective analysis of 20 patients (10 men, age 69.6 ± 12.3 years) with chronic total occlusions (CTOs) of the aorto-iliac and femoropopliteal segments who underwent a successful endovascular revascularization. Baseline and postprocedural evaluation of diastolic function was performed, and the primary endpoint was improvement in LV diastolic function, which was defined as any decrease of the baseline E/E' ratio or any increase of the baseline E' velocity after the index procedure. RESULTS: There was a significant effect of successful revascularization on the E/A ratio (from 1.5 ± 1.1 to 1.0 ± 0.3; P=.046) because of a significant increase of A velocity (from 86.3 ± 30.4 cm/s to 98.3 ± 21.8 cm/s; P=.03). The E' velocity (from 7.4 ± 2.0 cm/s to 8.3 ± 2.3 cm/s; P=.07) did not show a significant increase, but there was a significant reduction in E/E' ratio (from 14.6 ± 3.9 to 12.4 ± 3.3; P=.02). Logistic regression analysis did not identify possible predictors of improvement in LV diastolic function. CONCLUSION: Our results showed that a successful revascularization was associated with improvement in the echocardiographic parameters of LV diastolic function in patients with CTO of large lower-extremity artery, and these changes may be related to the afterload reduction.

Radioprotective lightweight caps in the interventional cardiology setting: a randomised controlled trial (PROTECT).

AIMS: The aim of this study was to test the radioprotection efficacy and comfort of newer bilayer barium sulphate-bismuth oxide composite (XPF) caps in an interventional cardiology setting. METHODS AND RESULTS: Operators were randomly assigned to wear standard fabric (n=59), 0.3 mm (n=74), or 0.5 mm (n=64) lead-equivalent XPF caps. Radiation doses were measured by using dosimeters placed outside and underneath the caps. Wearing comfort was assessed at the end of each measurement on a visual analogue scale (VAS) (0-100, with 100 indicating optimal comfort). Procedural data did not differ between the XPF and standard groups. Mean standard, XPF 0.3 mm, and XPF 0.5 mm cap weights were 12.5 g, 118.4 g, and 123.7 g, respectively. VAS comfort ratings of the standard and XPF caps did not differ significantly (p=0.272). The mean radiation protection was 12.0%, 95% CI: 4.9-19.1% (standard caps, n=35), 91.5%, 95% CI: 87.4-95.6% (XPF 0.3 mm caps, n=45) and 97.1%, 95% CI: 92.5-100% (XPF 0.5 mm caps, n=44) (p≤0.001 for all group comparisons). Using the XPF caps, a cumulative total radiation dose reduction by almost factor 10 was evident (272 procedures, 22,310 µSv outside the XPF caps, 2,770 µSv inside the caps). CONCLUSIONS: Lightweight XPF caps show comparable comfort to standard fabric caps, but provide substantial radiation protection during fluoroscopy-guided cardiac interventions.

Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study.

BACKGROUND: The EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High-Risk registry and REALISM Continued Access Study High-Risk Arm are prospective registries of patients who received the MitraClip device (Abbott Vascular, Santa Clara, California) for mitral regurgitation (MR) in the United States. OBJECTIVES: The purpose of this study was to report 12-month outcomes in high-risk patients treated with the percutaneous mitral valve edge-to-edge repair. METHODS: Patients with grades 3 to 4+ MR and a surgical mortality risk of ≥12%, based on the Society of Thoracic Surgeons risk calculator or the estimate of a surgeon coinvestigator following pre-specified protocol criteria, were enrolled. RESULTS: In the studies, 327 of 351 patients completed 12 months of follow-up. Patients were elderly (76 ± 11 years of age), with 70% having functional MR and 60% having prior cardiac surgery. The mitral valve device reduced MR to ≤2+ in 86% of patients at discharge (n = 325; p < 0.0001). Major adverse events at 30 days included death in 4.8%, myocardial infarction in 1.1%, and stroke in 2.6%. At 12 months, MR was ≤2+ in 84% of patients (n = 225; p < 0.0001). From baseline to 12 months, left ventricular (LV) end-diastolic volume improved from 161 ± 56 ml to 143 ± 53 ml (n = 203; p < 0.0001) and LV end-systolic volume improved from 87 ± 47 ml to 79 ± 44 ml (n = 202; p < 0.0001). New York Heart Association functional class improved from 82% in class III/IV at baseline to 83% in class I/II at 12 months (n = 234; p < 0.0001). The 36-item Short Form Health Survey physical and mental quality-of-life scores improved from baseline to 12 months (n = 191; p < 0.0001). Annual hospitalization rate for heart failure fell from 0.79% pre-procedure to 0.41% post-procedure (n = 338; p < 0.0001). Kaplan-Meier survival estimate at 12 months was 77.2%. CONCLUSIONS: The percutaneous mitral valve device significantly reduced MR, improved clinical symptoms, and decreased LV dimensions at 12 months in this high-surgical-risk cohort. (Endovascular Valve Edge-to-Edge REpair STudy [EVERESTIIRCT]; NCT00209274).

Prospective comparison of palpation versus ultrasound-guided radial access for cardiac catheterization.

BACKGROUND: Radial access is increasingly used for both diagnostic and interventional cardiac procedures. Prospective data comparing ultrasound- versus palpation-guided radial catheterization are largely lacking. METHODS: In this prospective, single-center study, a total of 183 consecutive patients scheduled for transradial cardiac catheterization by an experienced interventionalist were assigned 1:1 to either palpation- or ultrasound-guided radial access. Demographic and procedure parameters were prospectively recorded. RESULTS: Baseline demographic and clinical parameters did not differ significantly between the ultrasound group (n = 92) and palpation group (n = 91). The initial radial catheterization success rate (87% vs 86.8%; P=.999) and time to access (47 seconds [interquartile range (IQR), 20-90 seconds] versus 31 seconds [IQR, 20-75 seconds]; P=.179) did not differ between the ultrasound and palpation groups, respectively. Pulse quality (absent, weak, strong) was independently associated with access failure in both groups (P<.001). Obesity was associated with access failure in the palpation group (P=.005), but not in the ultrasound group (P=.544). In 3/12 cases (25%) in the ultrasound group and 2/6 cases (33%) in the palpation group, the operator was able to establish radial access using the alternative method (P=.710). If palpation-guided radial access failed, an additional ultrasound-guided attempt before crossover to femoral access was associated with a shorter overall time to access (525 seconds [IQR, 462-567 seconds] versus 744 seconds [IQR, 722-788 seconds]; P=.016). CONCLUSIONS: Ultrasound-guided radial access seems to provide no substantial additional benefit over palpation-guided access alone. Attempting the alternative guiding methods to establish radial access before crossover to femoral access seems to be a reasonable approach.

Simple and reliable determination of the modified rankin scale score in neurosurgical and neurological patients: the mRS-9Q.

BACKGROUND: The modified Rankin Scale (mRS) is a 6-level outcome scale used to assess level of function in neurological disease. OBJECTIVE: We examined the interobserver reliability and intraobserver reliability of the mRS-9Q, a 9-question "yes/no" survey that measures the mRS score in neurosurgical and neurological patients. METHODS: The mRS-9Q was administered in person or by telephone, and a Web-based tool was used to calculate the mRS score and to perform error checking. Part 1 compared the mRS-9Q with an mRS structured interview (n = 80). Part 2 compared mRS-9Q administration by telephone and by hard copy (n = 80). Part 3 compared mRS-9Q administration by an expert interviewer with administration by a nonexpert (n = 83). Part 4 examined reproducibility of the mRS-9Q over a 2-week period (n = 84). RESULTS: Agreement was very good in all study parts. In Part 1 (mRS-9Q vs mRS with structured interview), κ = 0.80 and κw = 0.96. In Part 2 (mRS-9Q telephone vs hard copy), κ = 0.83 and κw = 0.95. In Part 3 (mRS-9Q expert vs nonexpert), κ = 0.73 and κw = 0.93. In Part 4 (mRS-9Q reproducibility), κ = 0.76 and κw = 0.93. CONCLUSION: The mRS-9Q is a simple, easy-to-administer survey with a custom Web-based mRS calculation and error-checking tool. The mRS-9Q can reliably determine the mRS by hard copy survey or by telephone and can be administered by experts or nonmedical study personnel. The mRS-9Q can be used to measure functional outcome in a broad population of patients with neurosurgical and neurological diseases.

Estimulación intestinal en portadores de colostomía / Intestinal stimulation in patients with colostomy

Presentamos nuestra experiencia en la recuperación de la función evacuadora del intestino en pacientes ingresados en nuestro servicio con orientación diagnóstica de íleo paralítico o adinámico (funcional) que, por alguna causa, han sido intervenidos quirúrgicamente y son portadores de una colostomía temporal o permanente. Nuestra experiencia está basada en más de 10 pacientes, pero sólo se recogieron los datos de diez historias clínicas. La estimulación se ha conseguido introduciendo una sonda tipo Foley a través del estoma, procurando no producirle al paciente la más mínima molestia. Hemos buscado la justificación, tanto fisiológica como anatómica, que conlleva esta respuesta de recuperación del peristaltismo intestinal, utilizando un cuerpo sólido y no líquidos, con la idea de que así respetamos mejor el normal funcionamiento intestinal en estos pacientes, que ya lo tienen alterado al ser portadores de una colostomía(AU)

We presented/displayed our experience in the recovery of the evacuator function of the intestine in patients entered in our service with direction diagnoses of Ileo Paralítico or Adinámico (Functional), that by some cause has been taken part surgically and is carrying of a temporary or permanent colostomía. Our experience is based on more than 10 patients, but we have only gathered the data of ten clinical histories. This stimulation we have obtained it, introducing a sounding Foley type through estoma, trying not to produce to the patient the minimum annoyance to him. We have looked for justification, as much physiological as anatomical, that it entails this answer of recovery of the intestinal peristaltismo, using body solid and not liquid, with idea that thus we respected better the normal intestinal operation in these patients, that already has it altered, to the being carrying of a colostomía(AU)

[Intestinal stimulation in patients with colostomy]. / Estimulación intestinal en portadores de colostomía.

We presented/displayed our experience in the recovery of the evacuator function of the intestine in patients entered in our service with direction diagnoses of Ileo Paralitico or Adinámico (Functional), that by some cause has been taken part surgically and is carrying of a temporary or permanent colostomia. Our experience is based on more than 10 patients, but we have only gathered the data of ten clinical histories. This stimulation we have obtained it, introducing a sounding Foley type through estoma, trying not to produce to the patient the minimum annoyance to him. We have looked for justification, as much physiological as anatomical, that it entails this answer of recovery of the intestinal peristaltismo, using body solid and not liquid, with idea that thus we respected better the normal intestinal operation in these patients, that already has it altered, to the being carrying of a colostomia.

Anemia is associated with abdominal aortic aneurysm (AAA) size and decreased long-term survival after endovascular AAA repair.

OBJECTIVE: Anemia is a common comorbid condition in various inflammatory states and an established predictor of mortality in patients with chronic heart failure, ischemic heart disease, and end-stage renal disease. The present study of patients with abdominal aortic aneurysm (AAA) undergoing endovascular repair (EVAR) assessed the relationships between baseline hemoglobin concentration and AAA size, as well as anemia and long-term survival. METHODS: Between March 1994 and November 2006, 711 patients (65 women, mean age 75.8 +/- 7.8 years) underwent elective EVAR. Anemia was defined as a hemoglobin level <13 g/dL in men and <12 g/dL in women. Post-EVAR mean follow-up was 48.3 +/- 32.0 months. Association of hemoglobin level with AAA size was assessed with multiple linear regression. Mortality was determined with use of the internet-based Social Security Death Index and the electronic hospital record. Kaplan-Meier survival curves of anemic and nonanemic patient groups were compared by the log-rank method. Multivariable logistic regression models were used to determine the influence of anemia on vital status after EVAR. RESULTS: A total of 218/711 (30.7%) of AAA patients undergoing EVAR had anemia at baseline. After adjustment for various risk factors, hemoglobin level was inversely related to maximum AAA diameter (beta: - .144, 95%-CI: -1.482 - .322, P = .002). Post-EVAR survival was 65.5% at 5 years and 44.4% at 10 years. In long-term follow-up, survival was significantly lower in patients with anemia as compared to patients without anemia (P < .0001 by log-rank). Baseline hemoglobin levels were independently related to long-term mortality in multivariable Cox regression analysis adjusted for various risk factors (adjusted HR: 0.866, 95% CI: .783 to .958, P = .005). Within this model, statin use (adjusted HR: .517, 95% CI: .308 to .868, P = .013) was independently related to long-term survival, whereas baseline AAA diameter (adjusted HR: 1.022, 95% CI: 1.009 to 1.036, P = .001) was an independently associated with increased mortality. CONCLUSIONS: Baseline hemoglobin concentration is independently associated with AAA size and reduced long-term survival following EVAR. Thus, the presence or absence of anemia offers a potential refinement of existing risk stratification instruments.