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Background: Objective measures of frailty have not been well defined as risk factors for a poor outcome after transcatheter aortic valve insertion. We hypothesized that assisted care as a baseline patient characteristic was a simple objective measure of frailty. We reviewed our experience to assess for an association between assisted care and outcome of operation., Methods: We retrospectively reviewed the records of 597 patients operated with transcatheter aortic valve insertion from November 2008 through July 2015. The study cohort included patients with a dichotomous baseline characteristic of receiving assisted care (AC group, n = 60, 10.1%) or not receiving assisted care (NC group, n = 537, 89.9%). The endpoints of the study were operative stroke/death and 1-year survival., Results: The age of the patients was 80.6 ± 9.0 years, male sex was present in 349 (58.5%), and STS predicted risk of mortality was 9.2 ± 6.2%. Alternate access was used in 26 (43.3%) patients in the AC care group and in 220 (41.0%) in the NC group (P = 0.724). Operative stroke/death occurred in 4 (6.7%) patients in the AC group and in 25 (4.7%) in the NC group (P = 0.492). Mortality at 1 year in the AC group was 14.8 ± 5.2% and in the NC group was 12.9 ± 1.7%; (P = 0. 250)., Conclusions: Assisted care as a baseline patient characteristic does not result in increased operative stroke/death or 1-year mortality in patients following transcatheter aortic valve insertion. Assisted care should not by itself preclude operation. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Objectives: To determine the feasibility of automated co-registration of angiography and intravascular ultrasound (IVUS) to facilitate integration of these two imaging modalities in a synchronous manner., Background: IVUS provides cross-sectional imaging of coronary arteries but lacks overview of the vascular territory provided by angiography. Co-registration of angiography and IVUS would increase utility of IVUS in the clinical setting., Methods: Forty-nine consecutive patients undergoing surveillance for cardiac allograft vasculopathy with angiography and IVUS of the left anterior descending artery (LAD) were enrolled. A pre-IVUS angiogram of the LAD was performed followed by an ECG-triggered fluoroscopy (ECGTF) during IVUS pullback at 0.5 mm/s using an automatic pullback device. ECGTF was used to track the IVUS catheter during pullback and establish a spatial relationship to the pre-IVUS angiogram. Angio-IVUS co-registration was performed with a research prototype (Siemens Healthcare, Germany) and accuracy was evaluated by distance mismatch between angiography and IVUS images at vessel bifurcations., Results: Median age was 54 (44.5, 67) years. The population was 82.6% male with minimal risk factors. The median (IQR) co-registration distance mismatch measured at 108 bifurcations in 42 (85%) patients was 0.35 (0.00-1.16) mm. Seven patients were excluded due to inappropriate data acquisition (n = 3) and failure of tracking (n = 4), e.g., due to overlapping sternal wires. Estimated effective radiation dose for ECGTF was 0.09 mSv., Conclusion: This study demonstrates the feasibility of angio-IVUS co-registration which may be used as a clinical tool for localizing IVUS cross-sections along an angiographic roadmap. © 2015 Wiley Periodicals, Inc., (© 2015 Wiley Periodicals, Inc.)

Background: Alcohol septal ablation has emerged as a therapy for patients with obstructive hypertrophic cardiomyopathy (HCM). However, there are limited data on the predictors of success with the procedure., Methods: We examined patient characteristics and cardiac morphology as well as procedural data on 166 HCM patients (mean age, 63 years; 43% men), who underwent ablation at Mayo Clinic. Patients were contacted to determine vital status and symptoms to assess the primary endpoint of survival free of death and severe symptoms (New York Heart Association, class III or IV dyspnea)., Results: The strongest patient characteristics that predicted clinical success were older age, less severe left ventricular outflow tract gradient, lesser ventricular septal hypertrophy, and a smaller left anterior descending (LAD) diameter. Mitral valve geometry or ventricular septal morphology did not predict outcome. Patients with ≥3 characteristics (age ≥65 years, gradient <100 mmHg, septal hypertrophy ≤18 mm, LAD diameter <4.0 mm) had superior 4-year survival free of death and severe symptoms (90.4%) in comparison to those with two characteristics (81.6%) and ≤1 characteristic (57.5%). Case volume with >50 patients was an independent predictor of survival free of severe symptoms. The volume of alcohol injected, number of arteries injected, or size of septal perforator artery were not predictive of clinical success., Conclusions: Greater case volume and selection for key patient and anatomic characteristics are associated with superior outcomes with alcohol septal ablation., (Copyright © 2012 Wiley Periodicals, Inc.)

Objective: The objective of this study is to investigate the clinical outcome of a large cohort of patients with ST-segment elevation myocardial infarction (STEMI) treated with drug-eluting stents (DES) compared to bare metal stents (BMS)., Background: Several randomized controlled trials have demonstrated that PCI with the routine use of DES is safe and effective in patients with STEMI. However as randomized trials have strict inclusion criteria, further studies in unselected patient populations are needed., Methods: We performed a retrospective cohort analysis of the Mayo Clinic PCI database. A total of 552 consecutive STEMI patients who underwent a DES implantation between May 2003 and April 2006 were included in the study and compared to 557 who had BMS for STEMI earlier. No specific patient subsets were excluded., Results: Procedural success was achieved in 532 patients (96%). During initial hospitalization, 16 patients (2.9%) died and 8 (1.5%) suffered from a recurrent myocardial infarction. The median follow-up was 23 months (IQR: 13-27 months). At 12 months post discharge, the rate of target lesion revascularization and death were 2.9% and 3.7%, respectively, and survival free of major adverse cardiac events (MACE) was 90.9%. These rates were similar to or lower than those of patients treated for STEMI with BMS prior to the availability of DES., Conclusion: DES are safe and effective in the treatment of STEMI in an unselected cohort; 90.9% of patients are free of MACE at 12 months post discharge., (2008 Wiley-Liss, Inc.)

Objectives: The authors studied the safety and efficacy of the Cardiva Boomerang vascular closure device in patients undergoing diagnostic cardiac catheterization., Background: Conventional vascular closure devices (sutures, collagen plugs, or metal clips) have been associated with catastrophic complications including arterial occlusion and foreign body infections; furthermore, they cannot be utilized in patients with peripheral vascular disease or vascular access site in a vessel other than the common femoral artery. The Cardiva Boomerang device facilitates vascular hemostasis without leaving any foreign body behind at the access site, can be used in peripheral vascular disease, and can be used in vessels other than the common femoral artery, Methods: A total of 96 patients undergoing transfemoral diagnostic cardiac catheterization were included in this study, including 25 (26%) patients with contraindications to conventional closure devices. Femoral angiography was performed prior to deployment of the Cardiva Boomerang closure device. Patients were ambulated at 1 hr after hemostasis was achieved., Results: The device was successfully deployed and hemostasis achieved with the device alone in 95 (99%) patients. The device failed to deploy in 1 (1%) patient and required conversion to standard manual compression. Minor complications were observed in 5 (5%) patients. No patients experienced major complications including femoral hematoma > 4 cm, red blood cell transfusion, retroperitoneal bleed, arteriovenous fistula, pseudoaneurysm, infection, arterial occlusion, or vascular surgery., Conclusions: The Cardiva Boomerang device is safe and effective in patients undergoing diagnostic cardiac catheterization using the transfemoral approach, facilitating early ambulation with low rates of vascular complications., ((c) 2006 Wiley-Liss, Inc.)

Percutaneous revascularization of diseased saphenous vein grafts is associated with increased risk of adverse events, although the use of distal protection mitigates this to a significant extent. However, anatomic characteristics may preclude the use of such devices in a proportion of vein grafts intended for percutaneous treatment. We reviewed our consecutive experience of saphenous vein graft interventions from 1 May 2001 through 30 April 2002 to determine suitability for distal protection. Relevant angiographic characteristics included lesion within 5 mm of the ostium; lesion < 20 mm from the distal anastomosis; planned distal landing site of the occlusion balloon < 3 mm or > 6 mm in diameter; total occlusion of the vein graft; or lesion in a sequential vein graft distal to the first anastomosis. One hundred twenty-seven patients (140 procedures, 147 vein grafts) were treated. One or more of the angiographic exclusion criteria for a balloon occlusion protection system existed in 57% of grafts, while 42% had exclusions for a filter device. A large number of patients with vein graft disease intended for percutaneous treatment have anatomic exclusions to available distal protection technology., ((c) 2004 Wiley-Liss, Inc.)

Our objective was to document change in stent usage in a single practice over time and to study "off-label" compared to Food and Drug Administration (FDA)-approved indications. Although only two intracoronary stents have been approved by the FDA, the relatively limited approved indications do not account for the dramatic increase in stent implantation. This increase has important implications for patient health care delivery. This study of stent usage in a single center over a 36-mo period included all patients treated with coronary stents at the Mayo Clinic from January 1993-December 1995, and evaluated the relative difference in frequency between "off-label" and FDA-approved indications for implantation. During the 36-mo period of study, 3,614 interventional procedures were done and one or more stents were placed in 25.4% of patients. The proportion of patients receiving stents increased throughout this time: during the first 6-mo period, stents were placed in 6.2% of procedures; during the last 6-mo period, stents were placed in 46.3% of procedures, an eightfold increase. During the final 6 mo, an unapproved device or an unapproved indication for an approved device constituted 59.4% of all stent procedures. In addition, use of the non-FDA-approved adjunctive treatment regimen without warfarin increased from 2.9% in the first 6-mo period of observation to 82.7% in the last 6 mo. The use of stents increased strikingly over a 36-mo period, from 6% to 46% of all procedures. The majority of implantations were performed either for an "off-label" unapproved indication or with an unapproved device.

We describe a method of validation of computerized quantitative coronary arteriography and report the results of a new UNIX-based quantitative coronary arteriography software program developed for rapid on-line (digital) and off-line (digital or cinefilm) analysis. The UNIX operating system is widely available in computer systems using very fast processors and has excellent graphics capabilities. The system is potentially compatible with any cardiac digital x-ray system for on-line analysis and has been designed to incorporate an integrated database, have on-line and immediate recall capabilities, and provide digital access to all data. The accuracy (mean signed differences of the observed minus the true dimensions) and precision (pooled standard deviations of the measurements) of the program were determined x-ray vessel phantoms. Intra- and interobserver variabilities were assessed from in vivo studies during routine clinical coronary arteriography. Precision from the x-ray phantom studies (6-In. field of view) for digital images was 0.066 mm and for digitized cine images was 0.060 mm. Accuracy was 0.076 mm (overestimation) for digital images compared to 0.008 mm for digitized cine images. Diagnostic coronary catheters were also used for calibration; accuracy.varied according to size of catheter and whether or not they were filled with iodinated contrast. Intra- and interobserver variabilities were excellent and indicated that coronary lesion measurements were relatively user-independent. Thus, this easy to use and very fast UNIX based program appears to be robust with optimal accuracy and precision for clinical and research applications.

There is limited information regarding the use of excimer laser coronary angioplasty (ELCA) in patients with restenotic lesions. The purpose of this investigation was to compare the results of ELCA in patients with restenosis following prior PTCA with results obtained in de novo (no restenosis) patients. A retrospective review was obtained of all patients undergoing attempted ELCA at each of the 12 participating clinical investigative centers. There were 620 patients in the prior restenosis group and 949 in the de novo group. Both laser success (88% vs 78%) and procedural success (92% vs 88%) were higher in restenosis lesions compared with de novo lesions (P less than 0.001). Six-month follow-up was available in 40% of patients. Restenosis occurred in 49% of the prior restenosis group vs 44% of the de novo group (P nonsignificant) but death was more common in the de novo group (2.2 vs 0.4%, P = 0.01). ELCA can be performed with a high success rate in patients with restenosis following prior balloon angioplasty but recurrent restenosis following laser procedure remains a significant problem.

In this study, we compared stenosis severity by quantitative coronary angiography from video and cine images with visual estimation in 14 patients who underwent PTCA. Both cine and video analysis demonstrated a change from 65.2 +/- 2.5 to 36.5 +/- 3.1% diameter stenosis following PTCA, whereas visual estimation (average of three observers) showed improvement from 89.9 +/- 1.7 to 36.0 +/- 3.2%. Percent area stenosis from quantitative angiography showed improvement from 87.9 +/- 1.8 to 56.4 +/- 5.8. These data indicate that visual assessment overestimated percent diameter of severe lesions. To determine if video analysis could provide rapid quantitative assessment of PTCA results, we compared percent diameter and percent area stenosis by video with cine (diameter: correlation coefficient, 0.82; slope, 0.79; area: correlation coefficient, 0.86; slope, 0.83). These results indicate that video-based measurements are not different from cine-derived measurements. Quantitative coronary angiography provides an accurate estimate of changes produced by PTCA and can be performed rapidly and accurately on video images, thus making results available during the PTCA procedure.