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1.
Curr Cardiol Rep ; 22(9): 80, 2020 07 09.
Article in English | MEDLINE | ID: mdl-32648007

ABSTRACT

PURPOSE OF REVIEW: The TAVR procedure is a well-established therapy for patients with severe aortic stenosis at intermediate/high risk for surgery and a potential treatment for low-risk patients. It is much less invasive with short hospital stays and presents similar results compared with SAVR. Different "minimalist approach strategies" were proposed in order to obtain this performance. In these settings, transesophageal echocardiography (TEE) became less relevant for the TAVR procedure. The present review provides an update regarding the safety of TAVR without intraprocedural TEE. RECENT FINDINGS: Transthoracic echocardiography and fluoroscopy are the primary imaging tools during TAVR. Several studies proved that TAVR under local anesthesia without TEE is as safe as that performed under TEE guidance. However, not all patients have a proper window for TTE, and particular cases with complex anatomy can benefit from TEE support during the intervention. Intraprocedural TEE no longer plays a crucial role in the TAVR procedure, but in some instances, it remains of great help to detect and avoid complications.


Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Aortic Valve Stenosis/surgery , Echocardiography , Echocardiography, Transesophageal , Humans , Treatment Outcome
2.
Catheter Cardiovasc Interv ; 95(1): 97-104, 2020 01.
Article in English | MEDLINE | ID: mdl-30919577

ABSTRACT

BACKGROUND: Percutaneous recanalization of coronary chronic total occlusions (CTOs) traditionally relies on the use of dual-access and large bore catheters, with trans-femoral approach adoption in most cases. OBJECTIVES: Aim of this manuscript is to describe the outcomes of an alternative hybrid algorithm, called "Minimalistic Hybrid Algorithm," which has the purpose to minimize the use of double access, large bore catheters, and femoral approach in order to minimize the risk of vascular complications and patient's discomfort, without compromising efficacy. METHODS: In this single-center registry, a "minimalistic" approach was attempted in consecutive patients undergoing CTO PCI between March 2016 and October 2017. Data regarding the applicability of this algorithm and the related procedural success rates were collected, together with common demographic and angiographic characteristics. RESULTS: Of the 100 CTO PCI performed in the study period, 91(91%) were successfully approached according to the novel algorithm. Mean J-CTO score of all minimalistic procedures was 1.9 ± 1.2, with 31(34%) patients presenting with J-CTO score ≥3. In 52 procedures, the approach consisted of single-catheter access, 49(94.2%) of which were trans-radial. Out of the 39 patients approached with dual-catheters, 26(69.2%) were biradial, and 8(21%) radial-femoral. Procedural success in patients approached with the minimalistic algorithm was 89%, in line with the results of large-multicenter experiences nowadays available. CONCLUSIONS: Our results show that an alternative algorithm limiting the routine use of large bore catheters and trans-femoral approach is feasible in the clinical practice and yields good procedural outcomes.


Subject(s)
Algorithms , Catheterization, Peripheral , Clinical Protocols , Coronary Occlusion/therapy , Femoral Artery , Percutaneous Coronary Intervention , Radial Artery , Aged , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/instrumentation , Chronic Disease , Coronary Occlusion/diagnostic imaging , Coronary Occlusion/physiopathology , Decision Trees , Equipment Design , Female , Humans , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Registries , Retrospective Studies , Risk Factors , Treatment Outcome , Vascular Access Devices
3.
Front Cardiovasc Med ; 6: 146, 2019.
Article in English | MEDLINE | ID: mdl-31681798

ABSTRACT

Mitral valve disease affects more than 4 million people in the United States and it is the second most prevalent valvulopathy in Europe. The gold standard of treatment in these patients is surgical repair or mitral valve replacement. In the last decade, numerous transcatheter therapies have been developed to overcome the increased number of subjects with symptomatic severe mitral regurgitation and high surgical risk. The Mitraclip (Abbott Vascular, Menlo Park, CA), PASCAL (Edwards Lifesciences, Irvine, CA, USA), the Carillon™ Mitral Contour System™ (Cardiac Dimension Inc., Kirkland, WA, USA), the Mitralign™ (Mitralign, Tewksbury, Massachusetts), and the Cardioband (Edwards Lifesciences, Irvine, CA) are the principal percutaneous devices for mitral valve repair. We present an evidence-based clinical update that provides an overview of these technologies and their potential complications.

4.
Perfusion ; 34(7): 613-617, 2019 10.
Article in English | MEDLINE | ID: mdl-31027458

ABSTRACT

INTRODUCTION: Surgery for infective endocarditis imposes great challenges in post-operative circulatory and pulmonary support but the role of veno-arterial extra-corporal membrane oxygenation in this respect is unclear. METHODS: All patients undergoing veno-arterial extra-corporal membrane oxygenation after infective endocarditis surgery were analysed for age, gender, medical history, microorganisms, clinical outcome, complications and surgical procedure. RESULTS: Between 2012 and 2016, 13 patients received veno-arterial extra-corporal membrane oxygenation following infective endocarditis surgery. The median age was 62 years (33-73) and 8/13 were male. Previous cardiac surgery was present in nine patients. Surgery for infective endocarditis consisted of a Bentall procedure in 10 patients, 2 of which received concomitant mitral valve surgery and 2 received concomitant coronary artery bypass graft. Valvular surgery alone was performed in three patients. Mortality on veno-arterial extra-corporal membrane oxygenation was 62% (8/13). Mortality during intensive care unit stay was 77% (10/13). Survival to discharge was 23% (3/13). One patient reached the 1 year survival point. Two patients who survived to discharge have not yet reached the 1 year survival point. Patient-related complications occurred in 54% (7/13) of patients and consisted of haemorrhage at the cannula site in four patients, leg ischaemia in one patient, haemorrhage at another site in one patient and infection of the cannula in one patient. Extra-corporal membrane oxygenation hardware-related complications occurred in one case consisting of clot formation in the oxygenator. CONCLUSION: Veno-arterial extra-corporal membrane oxygenation in post-cardiotomy patients who were operated on for infective endocarditis is feasible, but outcome is poor.


Subject(s)
Endocarditis/complications , Extracorporeal Membrane Oxygenation/methods , Heart Failure/therapy , Adult , Aged , Endocarditis/surgery , Female , Heart Failure/etiology , Humans , Male , Middle Aged
5.
Curr Cardiol Rep ; 21(5): 37, 2019 03 28.
Article in English | MEDLINE | ID: mdl-30924027

ABSTRACT

PURPOSE OF REVIEW: This review aims to provide an updated overview and a clinical perspective on novel transcatheter tricuspid valve interventions (TTVI), highlighting potential challenges and future directions. RECENT FINDINGS: Severe tricuspid regurgitation (TR) is a predictor of mortality. However, a sizeable number of patients remain untreated until the end-stage when cardiac surgery presents a prohibitive risk. The emergent need in finding a treatment for patients with TR, deemed for surgery options, has encouraged the development of TTVI. These procedures mimic classical surgery techniques and are mainly divided in four categories: annuloplasty and coaptation devices, edge-to-edge techniques and transcatheter tricuspid valve replacement. Early studies showed promising results, but long-term follow-up data are not available. For patients with severe TR and high surgical risk, several percutaneous options are available. However, these therapies are in a growing phase and bigger studies and long term follow-up are needed to prove their efficacy.


Subject(s)
Cardiac Catheterization/methods , Heart Valve Prosthesis Implantation/methods , Tricuspid Valve Insufficiency/surgery , Tricuspid Valve/surgery , Humans , Treatment Outcome
6.
Int J Cardiol ; 283: 84-87, 2019 05 15.
Article in English | MEDLINE | ID: mdl-30449693

ABSTRACT

Percutaneous recanalization of coronary chronic total occlusions (CTOs) traditionally relies on the use of dual access and large bore catheters, with trans-femoral approach adoption in most of the cases. Aim of this manuscript is to describe an alternative algorithm, that we called "Minimalistic Hybrid Algorithm", in order to minimize the use of double access, large bore catheters, and femoral approach thus reducing patient's discomfort and possibly procedural complications. This algorithm can be interpreted as an evolution of the classic "Hybrid Algorithm" and requires the operator to be confident with all techniques known in this conventional algorithm. Indeed, all possible techniques and approaches of the conventional hybrid approach to treat CTOs are included in a novel diagram for procedural strategy, which offers an alternative sequence of steps to limit, whenever possible, the invasiveness of the procedure. After dividing the cases in "simple" or "complex" CTO lesions according to the available complexity scores and to the "feeling", knowledge and expertise of the operator, a systematic description of the procedural steps is provided. This includes antegrade and retrograde approaches, as well as sub-intimal and intra-luminal techniques, in order to maintain the simpler single-catheter transradial strategies in the first line for the simple CTO, and the adoption of more complex, double access and transfemoral ones in the further steps. The minimalistic hybrid algorithm herein described is a possible alternative sequence of steps in the setting of CTO recanalization, with the potential of limiting the use of double access, large bore catheters, and femoral approach.


Subject(s)
Algorithms , Coronary Occlusion/surgery , Minimally Invasive Surgical Procedures/methods , Percutaneous Coronary Intervention/methods , Chronic Disease , Coronary Angiography , Coronary Occlusion/diagnosis , Femoral Artery , Humans , Radial Artery
8.
Catheter Cardiovasc Interv ; 92(5): E299-E307, 2018 11 01.
Article in English | MEDLINE | ID: mdl-29411523

ABSTRACT

BACKGROUND: Coronary chronic total occlusions (CTO) usually coexist with diffusely diseased coronary segments proximal and/or distal to the CTO segment. During percutaneous treatment of CTO, multiple overlapping stents are often needed to treat these long lesions. OBJECTIVES: Aim of this study is to report the first use of long, tapered coronary sirolimus-eluting stents (SES) in this setting. METHODS AND RESULTS: This is a retrospective analysis of 100 consecutive patients undergoing CTO recanalization following the hybrid algorithm. Procedural success rate was 89% (11 failures). Among the successful cases, "conventional" drug-eluting stents(DES) were used in 40(44.9%) patients, while in 49(55%) patients long-tapered SES were attempted with a success rate of 98% (1 cross-over to regular stents). Total stent length in the long-tapered DES group was higher compared to the "conventional" stenting group (76 ± 28 mm vs 46 ± 22 mm, P < .001), with a similar total number of stent (1.6 ± 0.8 vs 1.9 ± 0.8). At quantitative coronary analysis, proximal and distal segment involvement was more extended in patients undergoing long-tapered stenting, with longer overall lesion length. No differences in periprocedural complications and clinical outcomes at a mean follow-up of 303 ± 179 days were observed. CONCLUSIONS: The use of long tapered coronary DES is technically feasible and safe for the percutaneous treatment of CTOs, especially for patients presenting with long lesions.


Subject(s)
Angioplasty, Balloon, Coronary/adverse effects , Angioplasty, Balloon, Coronary/instrumentation , Cardiovascular Agents/administration & dosage , Coronary Occlusion/therapy , Drug-Eluting Stents , Sirolimus/administration & dosage , Aged , Cardiovascular Agents/adverse effects , Chronic Disease , Coronary Occlusion/diagnostic imaging , Coronary Occlusion/physiopathology , Female , Humans , Male , Middle Aged , Prosthesis Design , Retrospective Studies , Sirolimus/adverse effects , Time Factors , Treatment Outcome , Vascular Patency
9.
Eur Heart J Qual Care Clin Outcomes ; 3(2): 141-147, 2017 04 01.
Article in English | MEDLINE | ID: mdl-28927175

ABSTRACT

Aims: After the introduction of the European Society of Cardiology (ESC) guidelines on prevention, diagnosis, and treatment of infective endocarditis (IE) in 2009, prophylaxis for patients at risk became less strict. We hypothesize that there will be a rise in IE after the introduction of the guideline update. Methods and Results: We performed a nationwide retrospective trend study using segmented regression analysis of the interrupted time series. The patient data were obtained via the national healthcare insurance database, which collects all the diagnoses nationwide. We compared the data before and after the introduction of the 2009 ESC guideline. Between 2005 and 2011, a total of 5213 patients were hospitalized with IE in the Netherlands. During this period, there was a significant increase in IE from 30.2 new cases per 1 000 000 in 2005 to 62.9 cases per 1 000 000 in 2011 (P < 0.001). In 2009, the incidence of IE increased significantly above the projected historical trend (rate ratio: 1.327, 95% CI: 1.205-1.462; P < 0.001). This coincides with the introduction of the 2009 ESC guideline. After the introduction of the ESC guideline, the streptococci-positive cultures increased significantly in the following years 2010-11 from 31.1 to 53.2% (P = 0.0031). Conclusion: This observational study shows that there has been a steady increase in the IE incidence between 2005 and 2011. After the introduction of the 2009 ESC guidelines, the incidence increased more than expected from previous historical trends. Furthermore, there was a significant increase in streptococci-related IE cases.


Subject(s)
Cardiology , Endocarditis/epidemiology , Practice Guidelines as Topic/standards , Registries , Societies, Medical , Adult , Aged , Aged, 80 and over , Endocarditis/diagnosis , Endocarditis/therapy , Europe , Female , Follow-Up Studies , Humans , Incidence , Male , Middle Aged , Netherlands/epidemiology , Retrospective Studies , Time Factors
10.
Cardiovasc Diagn Ther ; 6(2): 160-5, 2016 Apr.
Article in English | MEDLINE | ID: mdl-27054105

ABSTRACT

Percutaneous edge-to-edge mitral valve (MV) repair is a relatively new treatment option for mitral regurgitation (MR). After the feasibility and safety having been proved in low-surgical-risk patients, the use of this procedure has shifted more to the treatment of high-risk patients. With the absence of randomized controlled trials (RCT) for this particular subgroup, observational studies try to add evidence to the safety aspect of this procedure. These also provide short- and mid-term mortality figures. Several mortality predictors have been identified, which may help the optimal selection of patients who will benefit most from this technique. In this article we provide an overview of the literature about mortality and its predictors in patients treated with the percutaneous edge-to-edge device.

11.
Catheter Cardiovasc Interv ; 87(3): 467-75, 2016 Feb 15.
Article in English | MEDLINE | ID: mdl-26268819

ABSTRACT

OBJECTIVES: To evaluate long-term survival in high surgical risk patients undergoing percutaneous mitral valve repair (MVR) using the MitraClip(®) system and to identify preprocedural predictors of long-term mortality. BACKGROUND: Data for long-term survival and preprocedural predictors of mortality after percutaneous MVR in high surgical risk patients are sporadic. METHODS: From January 2009 to April 2013, 136 consecutive high surgical risk patients, with symptomatic moderate-to-severe or severe mitral regurgitation (MR), underwent percutaneous MVR using the MitraClip system. Cardiac and overall survival was determined at one and 2 years postprocedure. Univariate and multivariate analysis was performed to identify preprocedural predictors of long-term mortality. RESULTS: One year postprocedure, cardiac and overall survival was 86.7% and 84.6%, respectively and at 2 years cardiac and overall survival was 77.7% and 74.8%, respectively. In univariate analysis advanced age, lower body mass index, impaired renal function, elevated levels of log-N-terminal-pro-brain-natriuretic-peptide (log-NTproBNP), poor performance in functional tests (New York Heart Association (NYHA) class) and high logistic Euroscore (LES) and Society of Thoracic Surgeons (STS) score were identified as preprocedural predictors of long-term cardiac mortality. In multivariate analysis preoperative NYHA class III and IV, elevated levels of log-NTproBNP and advanced age predicted long-term cardiac mortality. CONCLUSIONS: Percutaneous MVR using the MitraClip system has favorable long-term survival rates in high surgical risk patients. Preprocedural NYHA functional class III and IV, elevated log-NTproBNP levels and advanced age predict higher long-term cardiac mortality and should be considered during patient selection.


Subject(s)
Cardiac Catheterization/mortality , Heart Valve Prosthesis Implantation/mortality , Mitral Valve Insufficiency/therapy , Mitral Valve , Aged , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Female , Heart Valve Prosthesis , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/instrumentation , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Mitral Valve/physiopathology , Mitral Valve Insufficiency/diagnosis , Mitral Valve Insufficiency/mortality , Mitral Valve Insufficiency/physiopathology , Multivariate Analysis , Proportional Hazards Models , Prosthesis Design , Risk Assessment , Risk Factors , Severity of Illness Index , Time Factors , Treatment Outcome
14.
JACC Cardiovasc Interv ; 7(8): 875-81, 2014 Aug.
Article in English | MEDLINE | ID: mdl-25147032

ABSTRACT

OBJECTIVES: The goal of this study was to compare survival between transcatheter mitral valve (MV) repair using MitraClip system (Abbott Vascular, Santa Clara, California), MV-surgery, and conservative treatment in high-surgical-risk patients symptomatic with severe mitral valve regurgitation (MR). BACKGROUND: Up to 50% of patients with symptomatic severe MR are denied for surgery due to high perioperative risk. Transcatheter MV repair might be an alternative. METHODS: Consecutive patients (n = 139) treated with transcatheter MV repair were included. Comparator surgically (n = 53) and conservatively (n = 59) treated patients were identified retrospectively. Surgical risk was based on the logistic European System for Cardiac Operative Risk Evaluation (log EuroSCORE) or the presence of relevant risk factors, as judged by the heart team. RESULTS: The log EuroSCORE was higher in the transcatheter MV repair group (23.9 ± 16.1%) than in the surgically (14.2 ± 8.9%) and conservatively (18.7 ± 13.2%, p < 0.0001) treated patients. Left ventricular ejection fraction was higher in surgical patients (43.9 ± 14.4%, p = 0.003), with similar values for the transcatheter MV repair (36.8 ± 15.3%) and conservatively treated (34.5 ± 16.5%) groups. After 1 year of follow-up, the transcatheter MV repair and surgery groups showed similar survival rates (85.8% and 85.2%, respectively), whereas 67.7% of conservatively treated patients survived. The same trend was observed after the second and third years. After weighting for propensity score and controlling for risk factors, both the transcatheter MV repair (hazard ratio [HR]: 0.41, 95% confidence interval [CI]: 0.22 to 0.78, p = 0.006) and surgical (HR: 0.52, 95% CI: 0.30 to 0.88, p = 0.014) groups showed better survival than the conservatively treated group. The transcatheter MV repair and surgical groups did not differ (HR: 1.25, 95% CI: 0.72 to 2.16, p = 0.430). CONCLUSIONS: Despite a higher log EuroSCORE, high-surgical-risk patients with symptomatic severe MR treated with transcatheter MV repair show similar survival rates compared with surgically treated patients, with both displaying survival benefit compared with conservative treatment.


Subject(s)
Cardiac Catheterization , Cardiac Surgical Procedures , Mitral Valve Insufficiency/therapy , Mitral Valve/surgery , Aged , Aged, 80 and over , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Cardiac Catheterization/mortality , Cardiac Surgical Procedures/adverse effects , Cardiac Surgical Procedures/instrumentation , Cardiac Surgical Procedures/mortality , Female , Humans , Kaplan-Meier Estimate , Male , Mitral Valve/physiopathology , Mitral Valve Insufficiency/diagnosis , Mitral Valve Insufficiency/mortality , Mitral Valve Insufficiency/physiopathology , Mitral Valve Insufficiency/surgery , Propensity Score , Proportional Hazards Models , Retrospective Studies , Risk Assessment , Risk Factors , Severity of Illness Index , Stroke Volume , Time Factors , Treatment Outcome , Ventricular Function, Left
15.
Catheter Cardiovasc Interv ; 80(5): 756-65, 2012 Nov 01.
Article in English | MEDLINE | ID: mdl-22419603

ABSTRACT

OBJECTIVE: The aim of this pilot study was to determine whether early atorvastatin treatment will reduce left ventricle (LV) remodeling, infarct size, and improve microvascular perfusion. BACKGROUND: In animal studies, early statin therapy reduces reperfusion injury after a percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). METHODS: Forty-two consecutive patients (82% male, mean age 61.2 ± 9.8) who underwent a primary PCI for a first ST-elevated AMI were randomized for pretreatment with atorvastatin 80 mg (n = 20) or placebo (n = 22) and continued with the same dosage daily for 1 week. All patients received atorvastatin 80 mg once daily 7 days after primary PCI. The LV function and infarct size were measured by magnetic resonance imaging within 1 day, at 1 week, and 3 months follow up. The primary endpoint was the end-systolic volume index (ESVI) at 3 months. Secondary endpoints were global LV function measurements, myocardial infarct size, biochemical cardiac markers, TIMI flow, and ST-T elevation resolution. RESULTS: ESVI 3 months after AMI was 25.1 mL/m(2) in the atorvastatin arm and 25.0 mL/m(2) in the placebo arm (P = 0.74). The differences in change from baseline to 3 months follow up in global LV function and myocardial infarct size did not differ between both treatment arms. Furthermore, biochemical markers, TIMI flow, and ST-T elevation resolution did not differ between atorvastatin and placebo arm. CONCLUSIONS: In this pilot study, pretreatment with atorvastatin in an acute myocardial infarction does not result in an improved cardiac function, microvascular perfusion, or decreased myocardial infarct size.


Subject(s)
Heptanoic Acids/administration & dosage , Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage , Myocardial Infarction/therapy , Percutaneous Coronary Intervention , Pyrroles/administration & dosage , Aged , Atorvastatin , Biomarkers/blood , Chi-Square Distribution , Coronary Circulation/drug effects , Drug Administration Schedule , Female , Hemodynamics/drug effects , Humans , Magnetic Resonance Imaging , Male , Microcirculation/drug effects , Middle Aged , Myocardial Infarction/blood , Myocardial Infarction/drug therapy , Myocardial Infarction/pathology , Myocardial Infarction/physiopathology , Myocardium/pathology , Netherlands , No-Reflow Phenomenon/etiology , No-Reflow Phenomenon/physiopathology , No-Reflow Phenomenon/prevention & control , Percutaneous Coronary Intervention/adverse effects , Pilot Projects , Predictive Value of Tests , Time Factors , Treatment Outcome , Ventricular Function, Left/drug effects , Ventricular Remodeling/drug effects
16.
JACC Cardiovasc Interv ; 5(1): 105-11, 2012 Jan.
Article in English | MEDLINE | ID: mdl-22230156

ABSTRACT

OBJECTIVES: This study sought to assess the feasibility and safety of percutaneous edge-to-edge mitral valve (MV) repair in patients with an unacceptably high operative risk. BACKGROUND: MV repair for mitral regurgitation (MR) can be accomplished by use of a clip that approximates the free edges of the mitral leaflets. METHODS: All patients were declined for surgery because of a high logistic EuroSCORE (>20%) or the presence of other specific surgical risk factors. Transthoracic echocardiography was performed before and 6 months after the procedure. Differences in New York Heart Association (NYHA) functional class, quality of life (QoL) using the Minnesota questionnaire, and 6-min walk test (6-MWT) distances were reported. RESULTS: Fifty-five procedures were performed in 52 patients (69.2% male, age 73.2 ± 10.1 years, logistic EuroSCORE 27.1 ± 17.0%). In 3 patients, partial clip detachment occurred; a second clip was placed successfully. One patient experienced cardiac tamponade. Two patients developed inguinal bleeding, of whom 1 needed surgery. Six patients (11.5%) died during 6-month follow-up (5 patients as a result of progressive heart failure and 1 noncardiac death). The MR grade before repair was ≥3 in 100%; after 6 months, a reduction in MR grade to ≤2 was present in 79% of the patients. Left ventricular (LV) end-diastolic diameter, LV ejection fraction, and systolic pulmonary artery pressure improved significantly. Accompanied improvements in NYHA functional class, QoL index, 6-MWT distances, and log N-terminal pro-B-type natriuretic peptide were observed. CONCLUSIONS: In a high-risk population, MR reduction can be achieved by percutaneous edge-to-edge valve repair, resulting in LV remodeling with improvement of functional capacity after 6 months.


Subject(s)
Catheterization/methods , Heart Valve Diseases/pathology , Heart Valve Prosthesis Implantation/methods , Mitral Valve/pathology , Aged , Catheterization/adverse effects , Catheterization/instrumentation , Echocardiography , Exercise Test , Female , Health Status Indicators , Heart Valve Diseases/diagnostic imaging , Heart Valve Diseases/surgery , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/instrumentation , Humans , Male , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Prognosis , Quality of Life , Risk Assessment , Severity of Illness Index , Stroke Volume , Surveys and Questionnaires , Ventricular Function, Left
19.
Circulation ; 114(9): 921-8, 2006 Aug 29.
Article in English | MEDLINE | ID: mdl-16908768

ABSTRACT

BACKGROUND: Sirolimus-eluting stents markedly reduce the risk of restenosis compared with bare metal stents. However, it is not known whether there are differences in effectiveness between bare metal and sirolimus-eluting stents in patients with total coronary occlusions. METHODS AND RESULTS: In a prospective, randomized, single-blind, 2-center trial, we enrolled 200 patients with total coronary occlusions: Half (n = 100) were randomly assigned to receive bare metal BxVelocity stents and half (n = 100) to receive sirolimus-eluting Cypher stents. The primary end point was angiographic binary in-segment restenosis rate at 6-month follow-up. Secondary end points were a composite of major adverse cardiac events, target vessel failure, binary in-stent restenosis rate, in-stent and in-segment minimal lumen diameter, percent diameter stenosis, and late luminal loss at 6-month follow-up. The sirolimus stent group showed a significantly lower in-stent binary restenosis rate of 7% compared with 36% in the bare metal stent group (P < 0.001). The in-segment binary restenosis rate was 11% in the group receiving a sirolimus stent versus 41% in the bare metal stent group (P < 0.0001), resulting in a target lesion revascularization rate of 4% in the sirolimus group versus 19% in the bare metal group (P < 0.001). Patients who received the drug-eluting stent also had significantly lower rates of target vessel revascularization, target vessel failure, and all major adverse cardiac events. CONCLUSIONS: In patients with total coronary occlusions, use of the sirolimus-eluting stents are superior to the bare metal stents with significant reduction in angiographic binary restenosis, resulting in significantly less need for target lesion and target vessel revascularization.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Coronary Stenosis/surgery , Sirolimus/therapeutic use , Stents , Aged , Coronary Angiography , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/drug therapy , Equipment Design , Female , Follow-Up Studies , Humans , Male , Middle Aged , Myocardial Ischemia/etiology , Risk Factors , Single-Blind Method
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