Feasibility and safety of transfemoral sheathless portico aortic valve implantation: Preliminary results in a single center experience.

BACKGROUND: Feasibility of transfemoral (TF) transcathteter aortic valve replacement (TAVR) is limited by the smallest diameter, the calcification and tortuosity of the iliofemoral access vessels. The use of the Portico system without delivery sheath results in significantly lower profile delivery system compared to standard technique. We herein report our single center experience, feasibility and safety of such an approach. METHODS: The Portico valve was implanted sheathless in 81 high-risk patients with severe aortic stenosis utilizing percutaneous femoral access. Mean minimal diameter of the ileo-femoral arterial access was 7.06 ± 1.89 mm. In most cases a multidetector computed tomography was performed before the intervention to assess the feasibility of vascular access and for aortic annulus measurements. The vascular access site was preclosed using two ProGlide suture systems. RESULTS: Device implantation was successful 98.7% of patients. Valve recapturing and repositioning as well as valve-in-valve deployment was performed in only one case (1.2%). There were no infarctions, 2 strokes (2.4%) and 2 acute kidney failure (2.4%), 1 major vascular complication1 (1.2%) 4 major bleedings (4.9%), 11 conductions disturbances and relative pace-maker implantations (14.2%). The mean gradient decreased from 42.3 ± 17 to 6.3 ± 2.78 mm Hg. Paravalvular regurgitation as assessed by TTE at discharge was absent or trivial in 19 patients, mild in 60 and moderate 1. Thirty-day mortality was 2.4%. CONCLUSIONS: Sheathless use of the Portico valve is feasible and appears to be safe, with excellent rates of complications and mortality in the short-term. Such an approach has the potential to further expand feasibility of TF TAVR to patients with severe peripheral arterial disease. Feasibility in patients with smaller femoral access and more challenging anatomy has to be proven in further studies. © 2017 Wiley Periodicals, Inc.

Long-term follow-up after left atrial appendage occlusion with comparison of transesophageal echocardiography versus computed tomography to guide medical therapy and data about postclosure cardioversion.

AIMS: The use of left atrial appendage (LAA) occluders in atrial fibrillation is increasing. There are few data on the comparison between transesophageal echocardiography (TEE) and computed tomography (MDCT) assessing peridevice flow and outcome of electrical cardioversion (ECV) in these patients. METHODS AND RESULTS: Single-center prospective registry from 2009 to 2015 including all LAA occluders to analyze success and complications during implantation and follow-up. Patients having ≥1 ECV were further analyzed. TEE was performed during implantation and at 6 weeks. In a subgroup of 77 patients, we compared MDCT with TEE at 6 weeks. Overall, 135 patients (69 ± 9 years; 70% male; CHA2 DS2 -VASc score: 3.6 ± 1.4; HAS-BLED score: 2.5 ± 0.6) received a LAA occluder (Watchman, n = 73; ACP-1, n = 59; Amulet, n = 3; PVI + LAA occluder, n = 91; and LAA occluder only, n = 44). Device implantation was successful in 131 (97%). Eight patients (5.9%) had major periprocedural complications (ischemic stroke/transient ischemic attacks, n = 4, tamponade, n = 2, device thrombosis, n = 2, Dressler syndrome, n = 1). The periprocedural complication rate was similar between concomitant procedure and LAA occluder only (8/91 vs. 5/44; P = 0.6). Twelve patients (9%) died (procedure-related, n = 2; 1%) during follow-up of 44 months (IQR: 43). MDCT (n = 77) at 6 weeks showed similar peridevice flow compared to TEE (TEE: 1.5 ± 1.9 mm vs. MDCT: 1.1 ± 2.2 mm, P = 0.25). Thromboembolic events occurred in 3 patients (CVA, n = 1; TIA, n = 2) during follow-up. In total, 41 ECV were performed in 26 patients (1.6 ± 0.9/patient), 13 months (IQR: 24) after implantation (<1 month: n = 8). No ECV-related clinical complications were observed. CONCLUSION: LAA occlusion is feasible with an acceptable safety profile and few events during long-term follow-up. ECV after LAA occlusion is feasible. MDCT could help to evaluate peridevice flow.

Safety and efficacy of the nMARQ catheter for paroxysmal and persistent atrial fibrillation.

AIMS: Circular irrigated radiofrequency ablation using the nMARQ catheter has recently been introduced for the treatment of atrial fibrillation (AF). The aim of this study is to report the safety and efficacy of catheter ablation using this technology in patients with paroxysmal and persistent AF. METHODS AND RESULTS: The data of a prospective registry describing the experience of a single operator using this technology on 327 consecutive patients were analysed. The mean procedure time was 69 ± 22 min for paroxysmal AF (n = 228) and 75 ± 23 min for persistent AF (n = 97). Follow-up was available for 206 (63%) patients for 6 ± 5 months (range 1-23, median 3.3). Single procedure success off antiarrhythmic drugs was 75% in paroxysmal AF and 52% in persistent AF. Including the 5% redo cases and those on antiarrhythmic medication, freedom from AF was documented in 90 and 83% of paroxysmal and persistent AF patients, respectively. There were no serious complications in the first 325 patients, but the last two consecutive patients (0.6%) developed atrio-oesophageal fistulas and had a fatal outcome. The catheter has been recalled from market. CONCLUSION: The nMARQ catheter is a highly effective tool for treatment of paroxysmal and persistent AF. Nevertheless, the occurrence of life-threatening oesophageal fistulas is of major concern and requires further investigation.

Electrical activation in the coronary sinus branches as a guide to cardiac resynchronisation therapy: rationale for a coordinate system.

BACKGROUND: For successful cardiac resynchronisation therapy (CRT) a spatial and electrical separation of right and left ventricular electrodes is essential. The spatial distribution of electrical delays within the coronary sinus (CS) tributaries has not yet been identified. OBJECTIVE: Electrical delays within the CS are described during sinus rhythm (SR) and right ventricular pacing (RVP). A coordinate system grading the mitral ring from 0° to 360° and three vertical segments is proposed to define the lead positions irrespective of individual CS branch orientation. METHODS: In 13 patients undergoing implantation of a CRT device 6±2.5, (median 5) lead positions within the CS were mapped during SR and RVP. The delay to the onset and the peak of the local signal was measured from the earliest QRS activation or the pacing spike. Fluoroscopic positions were compared to localizations on a nonfluoroscopic electrode imaging system. RESULTS: During SR, electrical delays in the CS were inhomogenous in patients with or without left bundle branch block (LBBB). During RVP, the delays increased by 44±32 ms (signal onset from 36±33 ms to 95±30 ms; p<0.001, signal peak from 105±44 ms to 156±30 ms; p<0.001). The activation pattern during RVP was homogeneous and predictable by taking the grading on the CS ring into account: (% QRS) = 78-0.002 (grade-162)(2), p<0.0001. This indicates that 78% of the QRS duration can be expected as a maximum peak delay at 162° on the CS ring. CONCLUSION: Electrical delays within the CS vary during SR, but prolong and become predictable during RVP. A coordinate system helps predicting the local delays and facilitates interindividual comparison of lead positions irrespective of CS branch anatomy.

Effects of AV delay programming on ventricular resynchronisation: role of radionuclide ventriculography.

PURPOSE: Optimal atrioventricular delay (AVD) setting for cardiac resynchronisation therapy, i.e. biventricular pacing in patients with heart failure, remains a formidable challenge. Thus, the purpose of this study was to evaluate the effects of different AVD on inter- and intra-ventricular resynchronisation using phase histograms of radionuclide ventriculography (RNV). METHODS: In 17 consecutive patients (mean age 64 +/- 6 years), RNV was performed 236 +/- 350 days after pacemaker implantation for cardiac resynchronisation therapy. Images were acquired during atrial pacing at 80 bpm and during biventricular pacing with AVD ranging from 80 to 160 ms. Inter-ventricular dyssynchrony was measured by the delay between the mean phase angles of the left and right ventricles. Intra-ventricular dyssynchrony was measured by the standard deviation (SD) of left ventricular phase histograms. RESULTS: Left ventricular (LV) ejection fraction (EF) was inversely correlated to LV dyssynchrony (SD of LV phase histogram, R = -0.82, p < 0.0001). However, the increase in LVEF by biventricular pacing (mean +4.4 +/- 4%) showed only modest correlation to the resulting resynchronisation effect (characterised by a -13 +/- 8 degrees decrease in LV phase histogram SD, R = -0.38, p < 0.0001). CONCLUSION: RNV is helpful in optimising pacing parameters for resynchronisation therapy. Varying AVD did not have a major impact on intra- or inter-ventricular resynchronisation. Thus, the benefit of AVD-based LVEF optimisation seems to result from atrioventricular resynchronisation.

Proximal embolic protection with aspiration in percutaneous coronary intervention using the Proxis device.

Distal embolization during primary percutaneous coronary intervention (PCI) occurs in at least 15% of patients and is a strong predictor of more extensive myocardial damage and a poor prognosis. Several devices are designed to evacuate the intracoronary thrombus or to prevent distal embolization. The Proxis device is a proximal embolic protection system that completely blocks antegrade flow during PCI. It may prevent distal embolization during recanalization of thrombotic coronary occlusion and thus improve outcome. We created a registry of 172 patients with ST-segment elevation myocardial infarction who underwent primary PCI with proximal embolic protection and aspiration. The mean ST-segment elevation resolution (STR) at 1 hour was 77.7%+/- 15.2; STR was greater than 50% in 94% and greater than 70% in 72% of patients. The 1-year cumulative major adverse cardiac and cerebrovascular events rate was 10.5%. The overall mortality at 1 year was 2.3%.

Myeloid-related protein 8/14 complex is released by monocytes and granulocytes at the site of coronary occlusion: a novel, early, and sensitive marker of acute coronary syndromes.

AIMS: We investigated whether myeloid-related protein 8/14 complex (MRP8/14) expressed by infiltrating monocytes and granulocytes may represent a mediator and early biomarker of acute coronary syndromes (ACS). METHODS AND RESULTS: Immunohistochemistry of coronary thrombi was done in 41 ACS patients. Subsequently, levels of MRP8/14 were assessed systemically in 75 patients with ACS and culprit lesions, with stable coronary artery disease (CAD), or with normal coronary arteries. In a subset of patients, MRP8/14 was measured systemically and at the site of coronary occlusion. Macrophages and granulocytes, but not platelets stained positive for MRP8/14 in 76% of 41 thrombi patients. In ACS, local MRP8/14 levels [22.0 (16.2-41.5) mg/L] were increased when compared with systemic levels [13.4 (8.1-14.7) mg/L, P = 0.03]. Systemic levels of MRP8/14 were markedly elevated [15.1 (12.1-21.8) mg/L, P = 0.001] in ACS when compared with stable CAD [4.6 (3.5-7.1) mg/L] or normals [4.8 (4.0-6.3) mg/L]. Using a cut-off level of 8 mg/L, MRP8/14 but not myoglobin or troponin, identified ACS presenting within 3 h from symptom onset. CONCLUSION: In ACS, MRP8/14 is markedly expressed at the site of coronary occlusion by invading phagocytes. The occurrence of elevated MRP8/14 in the systemic circulation prior to markers of myocardial necrosis makes it a prime candidate for the detection of unstable plaques and management of ACS.

High-frequency mechanical vibration to recanalize chronic total occlusions after failure to cross with conventional guidewires.

BACKGROUND: Crossing chronic total occlusions (CTO) of coronary arteries continues to challenge interventional cardiologists. A clinical study was undertaken in four European centers to examine the feasibility of using the new CROSSER system that utilizes high-frequency mechanical vibration to penetrate atherosclerotic plaque material to cross CTOs in patients where conventional guidewire techniques had failed. The objective of the study was to determine whether the CROSSER system could safely cross such CTOs. PATIENTS AND METHODS: A total of 55 CTO lesions in 53 patients were treated in two clinical phases: (1) Phase 1 feasibility study (30 CTOs), with a primary focus on device safety; and (2) Phase 2 pivotal study (25 CTOs) using an improved version of the device, with a primary focus on effectiveness. RESULTS: The primary endpoint of device efficacy and the secondary endpoint of clinical success were both 76% (19 of 25) in the pivotal study phase. No major adverse cardiac events of death, Q-wave myocardial infarction or target lesion revascularization (by either coronary artery bypass graft surgery or percutaneous coronary intervention) were observed through 30-day follow up. No coronary perforation or pericardial tamponade occurred. CONCLUSIONS: The CROSSER system is a safe device that can cross many occlusions after a conventional guidewire failure. With additional refinement and improvements to the device, this success rate could be further increased.

Failure to retrieve undeployed paclitaxel-eluting coronary stents.

Following the observation of difficulty in retrieving undeployed paclitaxel-eluting coronary stents (Taxus), we performed a retrospective analysis of 1,415 consecutive percutaneous coronary interventions and addressed the frequency of damaged or lost undeployed coronary stents. The incidence for Cypher, Taxus, and bare metal stents was 0%, 1.5%, and 0.3%, respectively (p = 0.0007). In the 11 cases involving Taxus stents, the treated vessel was invariably severely tortuous and/or calcified. The device was successfully retrieved despite being damaged and/or dislodged from the stent balloon in 5 cases; in 6 cases, stent embolization occurred. The clinical consequences were chronic claudication due to lower extremity device embolization in 1 patient and urgent surgical stent removal in 1 patient.

Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization.

BACKGROUND: Sirolimus-eluting stents and paclitaxel-eluting stents, as compared with bare-metal stents, reduce the risk of restenosis. It is unclear whether there are differences in safety and efficacy between the two types of drug-eluting stents. METHODS: We conducted a randomized, controlled, single-blind trial comparing sirolimus-eluting stents with paclitaxel-eluting stents in 1012 patients undergoing percutaneous coronary intervention. The primary end point was a composite of major adverse cardiac events (death from cardiac causes, myocardial infarction, and ischemia-driven revascularization of the target lesion) by nine months. Follow-up angiography was completed in 540 of 1012 patients (53.4 percent). RESULTS: The two groups had similar baseline clinical and angiographic characteristics. The rate of major adverse cardiac events at nine months was 6.2 percent in the sirolimus-stent group and 10.8 percent in the paclitaxel-stent group (hazard ratio, 0.56; 95 percent confidence interval, 0.36 to 0.86; P=0.009). The difference was driven by a lower rate of target-lesion revascularization in the sirolimus-stent group than in the paclitaxel-stent group (4.8 percent vs. 8.3 percent; hazard ratio, 0.56; 95 percent confidence interval, 0.34 to 0.93; P=0.03). Rates of death from cardiac causes were 0.6 percent in the sirolimus-stent group and 1.6 percent in the paclitaxel-stent group (P=0.15); the rates of myocardial infarction were 2.8 percent and 3.5 percent, respectively (P=0.49); and the rates of angiographic restenosis were 6.6 percent and 11.7 percent, respectively (P=0.02). CONCLUSIONS: As compared with paclitaxel-eluting stents, the use of sirolimus-eluting stents results in fewer major adverse cardiac events, primarily by decreasing the rates of clinical and angiographic restenosis.

Novel doppler assessment of intracoronary volumetric flow reserve: validation against PET in patients with or without flow-dependent vasodilation.

UNLABELLED: Volumetric blood flow (Q) determination requires simultaneous assessment of mean blood flow velocity and vessel cross-sectional area. At present, no method provides both values. Intracoronary Doppler-based assessment of coronary flow velocity reserve (CFVR) relies on average peak velocity (APV). Because this does not account for changes in velocity profile or vessel area usually occurring with flow-dependent vasodilation, results can be misleading. The aim of this clinical study was to validate against the current gold standard (measurement of myocardial perfusion reserve [MPR] by PET) a new, Doppler-based method for calculating coronary Q and coronary flow reserve (CFR). METHODS: Doppler-based intracoronary Q was measured with a proprietary guidewire device in a nonstenotic coronary artery at baseline and during adenosine-induced hyperemic flow (140 mug/kg/min intravenously during 7 min). Three gate positions were assessed, of which 2 were lying within the vessel and 1 was intersecting the vessel. The zeroth (M(0)) and the first (M(1)) Doppler moments of the intersecting gate were used to calculate mean blood flow velocity (M(1)/M(0)) and vessel area (M(0)), and M(0) of the 2 proximal gates was used to correct for scattering and attenuation. CFR was calculated as hyperemic/resting flow with Q and compared with APV-derived CFVR and with the corresponding segmental MPR obtained with (15)O-labeled water and PET. RESULTS: Q (CFR, 2.60 +/- 1.07) correlated well with PET (MPR, 2.58 +/- 1.11) (r = 0.832, P < 0.005; Bland-Altman limits, -1.42 to 1.09), whereas CFVR did not (r = 0.09, P = not statistically significant; Bland-Altman limits, -3.36 to 2.24). However, in vessels without dilation, there was no difference between CFR, CFVR, and MPR. CONCLUSION: This procedure for intracoronary Q measurement using the proprietary Doppler guidewire system, which accounts for both changes in flow profile and changes in vessel area, allows invasive, accurate assessment of CFR even in the presence of flow-dependent vasodilation.

Morphometric analysis of particulate debris extracted by four different embolic protection devices from coronary arteries, aortocoronary saphenous vein conduits, and carotid arteries.

Different embolic protection devices have been introduced for endovascular interventions: filters or balloon occlusion and aspiration systems. Despite widening use in a variety of vascular beds and clinical syndromes, little is known about the particulate burden liberated from different vascular beds and caught by different protection devices. We performed histologic and morphometric analyses of particulate debris captured during stenting of degenerated saphenous vein bypass grafts and native coronary arteries during acute myocardial infarction or during elective intervention and carotid arteries to assess the relative performance of different protection devices. We analyzed 232 interventions (90 saphenous vein bypass grafts, 77 native coronary arteries, and 65 carotid arteries) with 4 different devices (65 FilterWires, 99 Interceptors, 41 GuardWires, and 27 Proxis catheters) using the RapidVue particle analyzer. No difference in embolic volume retrieved was demonstrated between devices in saphenous vein bypass grafts and carotid interventions. A smaller volume of particulate debris was retrieved by the GuardWire compared with the FilterWire and the Proxis catheter in native coronary artery interventions. The Interceptor and the GuardWire captured more smaller particles than did the FilterWire or Proxis catheter. During saphenous vein bypass graft or carotid intervention, different embolic protection strategies were performed similarly. In native coronary artery stenting, however, proximal embolic protection retrieved larger amounts of debris than did distal filters or occlusion devices. These data may allow greater tailoring of embolic protection device development and application in specific anatomic locales.

Inflammatory markers at the site of ruptured plaque in acute myocardial infarction: locally increased interleukin-6 and serum amyloid A but decreased C-reactive protein.

BACKGROUND: Acute myocardial infarction (AMI) is associated with inflammation. However, it remains unclear whether it originates from the ruptured plaque or represents a systemic process. METHODS AND RESULTS: In 42 patients with AMI, a balloon-based embolization protection device and aspiration catheter (PercuSurge) were used during acute coronary interventions. Samples from the site of the ruptured plaque were taken under distal balloon occlusion. Systemic samples were taken from the aorta. Sera, plaques, and thrombi were analyzed for inflammatory markers and lipoproteins. Systemic levels of C-reactive protein (CRP), interleukin-6 (IL-6), and serum amyloid A (SAA) in the aorta amounted to 3.0 mg/L, 5.0 ng/L, and 22.1 mg/L, respectively (interquartile ranges [IQRs], 1.1 to 7.4 mg/L, 5.0 to 6.5 ng/L, and 13.9 to 27.0 mg/L, respectively). In blood surrounding ruptured plaques, local levels of IL-6 (8.9 ng/L; IQR, 5.0 to 16.9 ng/L) and SAA (24.3 mg/L; IQR, 16.3 to 44.0 mg/L) were significantly higher, whereas CRP levels (2.5 mg/L; IQR, 0.9 to 7.7 mg/L) were decreased compared with the aorta (all P<0.0001). The coronary levels of IL-6 determined in vivo showed biological activity in vitro. Harvested thrombus contained CD68-positive monocytes expressing IL-6 and showed extracellularly and intracellularly positive staining for SAA, whereas CRP was found exclusively in the cytoplasm of phagocyting white blood cells. CONCLUSIONS: Coronary levels of IL-6 and SAA at the site of plaque rupture were increased relative to the systemic circulation, indicating local production of biologically active inflammatory mediators. In contrast, CRP was locally decreased, at least in part by uptake by the phagocyting cells, suggesting a systemic origin of the protein.

Isolated dextrocardia in a commercial pilot candidate.

Positional anomalies of the heart are rare and are seldom found during routine physical examinations. We describe the case of a 25-yr-old Swiss airline pilot candidate whose aeromedical examination was normal except that an unusual ECG raised suspicion, leading to a diagnosis of dextrocardia with a normal arrangement of atria and abdominal viscera. This diagnosis in a pilot candidate should raise concern because a high percentage of such individuals have congenital heart defects. Further tests were conducted to rule out associated cardiac malformations, conduction anomalies, or rhythm disturbances. Testing also excluded other associated diseases such as primary ciliary dyskinesia and Kartagener's syndrome. Dextrocardia is not listed as a disqualifying condition in the applicable aeromedical regulations (Joint Aviation Authorities Medical Manual, Joint Aviation Requirements-Flight Crew Licensing guidelines). Therefore, after demonstrating that there were no physical, hemodynamic, or electrophysiological abnormalities, the candidate was allowed to enroll in civilian pilot training without restrictions.

Effectiveness and safety of the Proxis system in demonstrating retrograde coronary blood flow during proximal occlusion and in capturing embolic material.

The Feasibility And Safety Trial for its embolic protection device during transluminal intervention in coronary vessels: a European Registry (FASTER) was designed to demonstrate that (1) the Proxis embolic protection system can control anterograde flow and reverse blood flow in native coronary arteries and saphenous vein grafts; and (2) this system can capture embolic debris. Percutaneous coronary intervention on stenotic coronary lesions revolutionized treatment of coronary disease, but is associated with the risk of major adverse cardiac events. This prospective, nonrandomized, multicenter clinical feasibility and safety study enrolled 40 patients with 51 lesions at 4 centers who underwent treatment of stenotic lesions with proximal emboli protection (Proxis system). Proxis was successfully used 95% of the time, and embolic debris was qualitatively identified in all cases. Major adverse cardiac events occurred in 2 patients (5.0%): 1 late in-stent thrombosis resulting in death and 1 non-Q-wave infarction when a lesion was crossed before deployment of the Proxis system. Mean vessel occlusion time was 4.3 +/- 2.4 minutes. Native flow reversal was sufficient in 31 patients, with a mean aspirate volume of 11.8 +/- 6.5 ml. When the infusion catheter was used to augment reflow, mean occlusion time was 4.6 minutes. In conclusion, this trial is the first to demonstrate that retrograde blood flow can be achieved during proximal occlusion and that the Proxis system can be used safely during intervention of saphenous vein grafts and native coronary arterial lesions to capture embolic material.

Gender and noninvasive diagnosis of coronary artery disease in women and men.

OBJECTIVES: The purpose of this prospective study was to investigate the impact of the gender of physicians and patients on the accuracy of diagnosing coronary artery disease (CAD) based on the patient history only. METHODS: Screening involved 1082 consecutive patients undergoing coronary angiography for suspected CAD. Known CAD was an exclusion criterion. The inclusion criteria were met by 144 patients (47 females). All patients were inverviewed by both an experienced male cardiologist (n=6) and an experienced female cardiologist (n=5), who had to state before coronary angiography if CAD was present relying solely on the patient interview. Eligible subjects also answered a questionnaire. Diagnostic performance to assess the presence or absence of CAD by history taking by male and female cardiologists, exercise testing, patient self-assessment, and the questionnaire were compared. RESULTS: Coronary angiography showed significant CAD in 20 females (43%) and 70 males (72%). Diagnostic accuracy was not different between male (79%) and female (79%) cardiologists and comparable to the results of exercise testing (74%) but better than self-assessment by the patients (65%, p=0.01) or a questionnaire (68%, p=0.01). The accuracy of female physicians was better in men than in women (85% vs. 66%, p=0.01). The specificity of male physicians tended to be better in women than in men (74% vs. 59%, p=0.25). Female cardiologists overestimated the presence of CAD in women (specificity 48% vs. 74%, p=0.04). CONCLUSIONS: The female cardiologists did not assess women more accurately than did their male colleagues. The diagnostic accuracy of these male and female cardiologists was quite good. However, both tend to assess patients of the opposite gender more specifically. There may be an impact of the gender of the physician on the accuracy of diagnosis of CAD by history taking.

Comparison of costs and safety of a suture-mediated closure device with conventional manual compression after coronary artery interventions.

The aim of this study was to assess costs and safety of immediate femoral sheath removal and closure with a suture-mediated closure device (Perclose, Menlo Park, CA) in patients undergoing elective (PCI). A total of 193 patients was prospectively randomized to immediate arterial sheath removal and access site closure with a suture-mediated closure device (SMC; n = 96) or sheath removal 4 hr after PCI followed by manual compression (MC; n = 97). In the SMC group, patients were ambulated 4 hr after elective PCI if hemostasis was achieved. In the MC group, patients were ambulated the day after the procedure. In addition to safety, total direct costs including physician and nursing time, infrastructure, and the device were assessed in both groups. Total direct costs were significantly (all P < 0.001) lower in the SMC group. Successful hemostasis without major complication was achieved in all patients. The time to achieve hemostasis was significantly shorter in the SMC group (7.1 +/- 3.4 vs. 22.9 +/- 14.0 min; P < 0.01) and 85% of SMC patients were ambulated on the day of intervention. Suture-mediated closure allows a reduction in hospitalization time, leading to significant cost savings due to decreased personnel and infrastructural demands. In addition, the use of SMC is safe and convenient to the patients.