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There is limited organized “real life” data regarding the long-term structural and functional durability of transcatheter aortic valve implants, a topic of major importance. We assessed the 5-year structural and functional integrity outcomes following trans-catheter aortic valve implantation (TAVI) with both self-expandable and balloon-expandable prosthetic valve devices. This study included 450 consecutive patients who underwent TAVI for severe symptomatic aortic stenosis (AS) between September 2008 and December 2011. Data were acquired from a multicenter Israeli registry and the median follow up time was 5.6 years. In 184 patients (40.9%) who survived 5 years, prostheses displayed sustained hemodynamic performance, with average peak and mean aortic valve gradients of 16.2 ± 8.9 and 9.2 ± 6.6 mm Hg, respectively. Late structural valve deterioration was found in 22 (12.3%) patients. Of these, 16 (8.9%) experienced valve deterioration and 6 (3.3%) experienced valve failure. Among the 6 patients with bioprosthetic valve failure, only 3 underwent re-interventions. Bioprosthetic valve dysfunction occurred more frequently in patients with small valves (23 mm) and high peak and mean transvalvular gradients at baseline. In conclusion, a relatively low rate of valve deterioration or failure was noted in our long-term follow-up study after TAVI procedures with both the catheter-based self-expandable and balloon-expandable prosthetic valves.

Blood group systems based on red blood cell antigens are genetically determined and can identify patients at risk. Type non-O of the ABO blood group system has been associated with coronary artery disease, thrombosis, and a worse prognosis. The present study evaluated the distribution of blood group types in patients with heart failure (HF) and the impact on clinical outcome. We evaluated the ABO and Rhesus D antigen (RhD) blood types in a large cohort of chronic HF patients (n = 3,815). ABO blood type distribution in the HF population was not significantly different to that reported in the general national population (A 40%, B 20%, AB 8%, and O 33%). The percentage of Rh-negative per blood type was also similar (A 10%, B 9%, AB 10%, and O 7%). Patients with type O were more likely to be hypertensive compared with non-O type. Mean follow-up was 4.2 years. Overall survival during follow-up was 55%. Cox regression analysis after adjustment for significant predictors demonstrated that RhD-negative was associated with a worse prognosis in patients with ischemic cardiomyopathy (n = 2,881, 76%): hazard ratio 1.26, 95% confidence interval 1.04 to 1.53, p = 0.02. Type non-O was also independently associated with a worse prognosis compared with type O in patients with non-ischemic cardiomyopathy: hazard ratio 1.32, 95% confidence interval 1.04 to 1.67, p = 0.02. In conclusion, blood group type distribution in HF patients are similar to the general population. RhD-negative is associated with a worse prognosis in patients with ischemic cardiomyopathy.

Large thrombus burden negatively affects the results of percutaneous coronary intervention (PCI) for acute ST-segment elevation myocardial infarction (STEMI). We investigated the impact of thrombus burden in patients with STEMI undergoing primary PCI with the mesh-covered MGuard stent (InspireMD Ltd., Tel Aviv, Israel) versus a control bare-metal or drug-eluting stent. In 433 patients with STEMI randomized to the MGuard stent versus a control stent, angiographically visible thrombus was identified in 383 patients (88.5%), with median thrombus area 30.15 mm(2) (22.70, 41.93). Lesions with large thrombus (areamedian) were treated with more frequent use of manual aspiration (80.8% vs 65.8%, p = 0.0009) and longer (22.1 ± 5.9 vs 19.4 ± 5.4 mm, p0.0001) and larger (3.46 ± 0.40 vs 3.29 ± 0.36 mm, p0.0001) stents. PCI of lesions with large thrombus burden had more thrombotic complications (30.6% vs 15.9%, p = 0.0007) and reduced angiographic success (80.3% vs 91.1%, p = 0.003). In large thrombus lesions, the MGuard stent was more effective than control stents in achieving Thrombolysis In Myocardial Infarction-3 flow (87.9% vs 74.5%, p = 0.02) and tended to result in less slow flow or no reflow (8.8% vs 17.6%, p = 0.07). ST-segment resolution was improved with the MGuard, and clinical outcomes were favorable in both stent groups, regardless of thrombus burden. In conclusion, reperfusion success is reduced after primary PCI in lesions with large thrombus burden, an outcome that may be modified by the MGuard stent.

The risk of death in heart failure (HF) is high. The electrocardiographic spatial QRS-T angle reflects changes in the direction of the repolarization sequence and predicts death in the general population. The frontal QRS-T angle is simple to measure but has not been evaluated in a large chronic HF cohort. We examined the significance of the frontal QRS-T angle in predicting the clinical outcome in a large cohort of patients with HF. The QRS-T angle was calculated from the frontal QRS and T axis of the baseline 12-lead surface electrocardiogram. The patients were followed for cardiac-related hospitalizations and death; 5,038 patients with HF were evaluated. The mean follow-up period was 576 days; 51% were men. Overall survival during the follow-up period was 83%. Cox regression analysis after adjustment for significant predictors, including age, gender, ischemic heart disease, hypertension, atrial fibrillation, body mass index, pulse, serum hemoglobin, sodium, estimated glomerular filtration rate, and urea levels, demonstrated that the QRS-T angle was an incremental predictor of increased mortality in both genders. For women, a QRS-T angle of ≥60° had a hazard ratio of 1.35 (95% confidence interval 1.04 to 1.75; p

Potassium levels are often abnormal in patients with heart failure (HF) and have a detrimental effect on clinical outcome. We evaluated potassium levels in a real-world cohort of patients with HF and its effect on mortality. All patients with a diagnosis of HF at a health maintenance organization were evaluated and followed for cardiac-related hospitalizations and death. The cohort consisted of 6,073 patients with HF. Mean potassium levels were 4.57 ± 0.53 mmol/L. Most patients (68%) had potassium levels in the normal range (4.0 to 5.0 mmol/L). High-normal potassium levels (5.0 to 5.5) were present in 17% of the patients, low potassium levels (4.0) in 11%, and hyperkalemia (K ≥5.5) in 4%. Mean follow-up was 576 days. The overall mortality rate during this period was 14%. Survival rate by Kaplan-Meier analysis demonstrated that hypokalemia (K ≤3.5) was associated with the lowest survival rate. Survival was highest in patients with high-normal potassium levels. Cox regression analysis after adjustment for significant predictors including co-morbidities and standard HF drug therapies demonstrated that high-normal potassium levels were independently associated with reduced mortality compared with normal reference levels (hazard ratio 0.78, 95 confidence interval [CI] 0.64 to 0.95, p = 0.01). Subgroup analysis showed improved outcome with high-normal potassium levels in patients with reduced renal function, spironolactone, and loop diuretic therapy. In conclusion, potassium levels in the high-normal range appear to be safe and are associated with an improved outcome in patients with HF.

The E-Five is a prospective, nonrandomized, multicenter global registry of patients receiving the Endeavor zotarolimus-eluting stent (ZES; Medtronic Vascular, Santa Rosa, CA) for the treatment of coronary artery stenosis. All consecutive procedures were included in the registry, without any specific anatomic or clinical exclusion criteria. Since October 2005, 8,318 patients have been enrolled in the E-Five Registry at 188 hospitals in Europe, South America, Australia, New Zealand, and Asia, and 10,343 lesions have been treated. The primary end point is the rate of major adverse cardiac events (MACE) at 1 year. Of the lesions treated, 60.3% were American College of Cardiology (ACC) and American Heart Association (AHA) type B2 or C lesions, and 16.5% were bifurcation stenoses. The average lesion length was 18.50 +/- 10.60 mm, and 50.6% of the lesions wereor =16 mm long. Clinical data have been analyzed for 1,989 of the patients (23.9%) receiving the Endeavor ZES in this registry, with 30-day clinical outcomes available for 1,985 of these 1,989 patients (99.8%). The acute procedure success rate in these patients was 98.6%, comparable with procedure success rates observed in previous Endeavor ZES clinical trials. The 30-day rate of MACE in these patients was just 1.7%, comparable with 30-day rates of MACE observed in previous ENDEAVOR clinical trials. In an early analysis of a subgroup of patients enrolled in the E-Five Registry, the Endeavor ZES demonstrated encouraging acute and 30-day outcomes in a real-world population of patients who underwent single-vessel or multivessel percutaneous coronary intervention.

This study examines the effect of coronary angioplasty on the progression and appearance of new disease in sites of the coronary tree that were not dilated by the balloon. We examined 355 pairs of coronary angiograms from 252 patients. The study consisted of consecutive patients who were referred for catheterization1 month after successful angioplasty. Progression/regression and the appearance of new narrowings at sites not dilated by angioplasty were determined. The life-table method was used to determine outcome, and any event (progression, regression, and new narrowing) was analyzed according to the time of occurrence. The angioplasty artery was compared with the non-angioplasty artery and the effect of restenosis was determined by comparing arteries with and without restenosis. Progression/regression rates were not significantly different in angioplasty and non-angioplasty arteries. More new narrowings were identified in the angioplasty artery (p0.01). With regard to narrowings located in the angioplasty artery, progression was more common, regression less common, and the appearance of new narrowings more common in arteries with restenosis than in non-angioplasty arteries or arteries without restenosis. We believe that mechanical trauma to the artery during angioplasty could accelerate disease progression and the appearance of new narrowings in angioplasty arteries, whereas normalization of flow rate and pattern, especially in arteries without restenosis, attenuates the rate of progression and the appearance of new narrowings in these arteries. The final outcome depends on the balance between these factors.

To compare the long-term prognosis of a group of patients treated by an early invasive approach after a non-Q-wave anterior wall acute myocardial infarction (AMI) with a similar group treated conservatively, data from 110 consecutive patients with non-Q-wave AMI were retrospectively obtained from 3 different hospitals: (1) a hospital with coronary angioplasty and coronary bypass facilities favoring on early invasive approach, (2) a hospital with a catheterization laboratory and no coronary angioplasty or coronary bypass facilities, and (3) a community hospital without a catheterization laboratory. Patients were divided according to the presence or absence of an early invasive approach: those who had undergone in-hospital catheterization and revascularization (n = 55) and those with a conservative approach (n = 55). The early invasive approach resulted in a significant decrease in major events. The rate of recurrent myocardial infarction was 29% in the conservative group versus 7.2% in the invasive group (p = 0.025). Survival rate curves at 3-year follow-up showed significant differences in mortality (p = 0.001), recurrent myocardial infarction (p = 0.002), recurrent angina pectoris (p = 0.001), and development of congestive heart failure (p = 0.05). Multivariate analysis disclosed the early invasive approach to be an independent predictor for decreasing the likelihood of recurrent infarction by 86% (odds ratio 0.14, confidence intervals 0.04 to 0.48, p = 0.0006), and for decreasing the likelihood of recurrent angina by 66% (odds ratio 0.34, confidence intervals 0.18 to 0.63, p0.005). The early invasive strategy may result in an improved outcome in the treatment of patients with non-Q-wave anterior wall AMI compared with patients treated conservatively.

The combination of diagnostic angiography and angioplasty as a single procedure is becoming common practice in many institutions, but the feasibility and safety of this strategy have not been reported. This report describes 2,069 patients who underwent coronary angioplasty over a 3-year period at an institution where combined angiography and angioplasty is the norm. All patients were prepared before angiography for potential immediate angioplasty. In 1,719 patients, angioplasty was performed immediately after the diagnostic angiogram, while separate procedures were performed in 350 patients. Of those 350 patients, 254 were referred for angioplasty after diagnostic angiography at other hospitals. One thousand one hundred ninety-seven patients were admitted electively for treatment of stable angina pectoris, and 872 underwent procedures during hospitalization for unstable angina or acute myocardial infarction. One thousand nine hundred seven patients (92.2%) had successful angioplasties; in 130 patients (6.3%) the lesion could not be dilated, but no complication occurred, and in 32 patients (1.5%) angioplasty ended with a major complication (0.8% death, 1.0% Q-wave myocardial infarction, 0.5% emergency coronary artery bypass surgery). There was no difference between the combined and staged groups with regard to success, major and minor complication rates or in length of hospitalization after angioplasty. We conclude that routine combined strategy for angiography and angioplasty is feasible, safe, easier for the patient, and more cost-effective than 2 separate procedures.

A national study was performed in early 1992 in the 25 operating coronary care units in Israel, which enabled the assessment of whether the therapeutic management of patients with acute myocardial infarction was affected by patient gender. During a 2-month period, 1,014 consecutive patients with acute myocardial infarction were hospitalized. Thrombolytic therapy was given to 47% of men (362 of 769), and 43% of women (106 of 245) (p = NS). After adjustment for age, no gender differences in the administration of thrombolytic therapy were noted (odds ratio 0.95; 95% confidence interval 0.73–1.23). Coronary angiography was more frequently performed in men (22%) than in women (16%) (p

The angiographic appearance of the coronary arteries was examined in 308 patients with acute myocardial infarction (AMI) who received highdose intravenous thrombolytic therapy. Coronary angiography was performed on day 7 after admission to the hospital. Patients had an average of 2.4 discrete arterial narrowings or obstructions. The narrowings were proximal and related to bifurcations. Four fifths of the culprit arteries were patent; 104 (34%) had a ruptured plaque, 22 (7%) had an ulcerated plaque, and in 190 (62%) the lesions were eccentric. Patients differed from a comparable, previously studied, control series of 302 patients with chronic stable angina pectoris who had more extensive disease. They had 5.7 narrowings/patient, also located proximally and at bifurcations, but more widely distributed in the coronary tree. Patients with AMI who are suitable for thrombolysis have a unique coronary angiographic picture. The data confirm that AMI is caused by sudden rupture of a localized atheromatous plaque that initiates an obstructive thrombotic cascade.

Mechanical trauma caused by percutaneous coronary intervention is a major factor contributing to subsequent cardiac events, restenosis, and the need for target lesion revascularization (TLR). To minimize this trauma, we developed a Computerized Angioplasty Pressure Sensor and Inflator Device (CAPSID) for gradual inflation. The objective of the present prospective randomized study was to examine whether the use of this novel device reduced TLR, as well as cardiac events, in patients undergoing stenting. Patients undergoing coronary stenting were eligible and randomized to receive CAPSID or standard manual percutaneous coronary intervention. In the CAPSID group, slow, gradual balloon inflation was performed using a personal computer. Patients with acute ST-elevation myocardial infarction or the need for percutaneous coronary intervention for total occlusions, left main disease, and vein grafts were excluded. Clinical follow-up for major adverse cardiac events, including death, acute myocardial infarction, and TLR, was performed at 12 months. A total of 310 patients were enrolled in the study. No significant differences were found in the clinical characteristics between the CAPSID and control groups. At 1 year of follow-up, the CAPSID group had had a significantly lower rate of major adverse cardiac events (8% vs 18%, p

The aim of this study was to evaluate long-term (3.4 years) outcomes and predictors of clinical events in patients treated with sirolimus-eluting stents in the Israeli arm of the e-Cypher registry. From July 2002 to October 2003, 488 patients from 8 medical centers in Israel were enrolled in the e-Cypher registry. Nineteen patients with interventions in venous grafts were excluded from the final analysis. Long-term follow-up was completed for 98% of the remaining patients. There were 29 cases (6.3%) of death (3.9% cardiac and 2.4% noncardiac deaths). According to the broad academic research consortium definition of stent thrombosis, there were 19 cases (4%) of stent thrombosis (incidence density 0.9 cases/100 patient-years). There were 46 cases (9.9%) of target lesion revascularization and 76 cases (16.3%) of major adverse cardiac events (combination of death, myocardial infarction, and target lesion revascularization). Independent predictors of stent thrombosis were renal failure (hazard ratio 9.6, 95% confidence interval 1.9 to 47), stent length (hazard ratio 1.1, 95% confidence interval 1 to 1.2), and the off-label use of sirolimus-eluting stents (hazard ratio 5.3, 95% confidence interval 1.2 to 24). In conclusion, during >3 years of follow-up, stent thrombosis, major adverse cardiac events, and target lesion revascularization continued at constant rates over time. Clinical parameters such as renal failure and procedural parameters such as off-label use and stent length were independent predictors of stent thrombosis.

Previous studies have shown a high incidence of cardiovascular complications when noncardiac surgery (NCS) is performed after coronary stenting. No study has compared the outcomes of NCS after stenting compared with percutaneous transluminal coronary angioplasty (PTCA) alone. The records of all patients who underwent NCS within 3 months of percutaneous coronary intervention at our institution were reviewed for adverse clinical events with the end points of acute myocardial infarction, major bleeding, and deathor = 6 months after NCS. A total of 216 consecutive patients were included in the study. Of these, 122 (56%) underwent PTCA and 94 (44%) underwent stenting. A total of 26 patients (12%) died, 13 in the stent group (14%) and 13 in the PTCA group (11%), a nonsignificant difference. The incidence of acute myocardial infarction and major bleeding was 7% and 16% in the stent group and 6% and 13% in the PTCA group (p = NS), respectively. Significantly more events occurred in the 2 groups when NCS was performed within 2 weeks of percutaneous coronary intervention. In conclusion, our study has demonstrated high rates of perioperative morbidity and mortality after NCS in patients undergoing PTCA alone, as well as stenting. These findings support the current guidelines regarding the risk of NCS after stenting but suggest they be extended to PTCA as well.

The transradial approach has currently been advocated as an alternative catheferization method for coronary angiography and angioplasty, due to the recent miniaturization of angioplasty equipment. The purpose of this study was to assess the practical clinical applicability of this method. From June to November 1994, 100 patients underwent coronary angiography and angioplasty with the transradial approach. Their mean age was 66.6 ± 11.2 years, and 79 were men. In 4, radial puncture was not successful, and in 3, femoral access was necessary to complete the procedure. Coronary angioplasty was performed in 63 patients (76 lesions) with angiographic success (per lesion) of 96%. In 5 patients, a stent was successfully implanted. All patients were ambulatory on the day after the angioplasty procedure. In 98% of the patients, the introducer was taken out 1 to 4 hours after the procedure by local compression using a special custom-made device. No patient required blood transfusion. Major complications occurred in 2 patients; both had a cerebrovascular accident (1 probably not procedure-related), and both recovered. A radial pulse was palpated in 91 of the patients before discharge, and in 6 others, adequate flow could be heard with Doppler. In 2 patients, radial flow was restored within several weeks. None of the patients suffered from ischemia of the hand. Two patients had a small pseudoaneurysm successfully treated by local compression. Thus, coronary angioplasty can be performed safely using the transradial approach with relatively few vascular complications and with better patient comfort. However, the procedure is more time-consuming initially compared with the transfemoral approach due to a learning curve regarding equipment selection and catheter manipulation.

The role of plasma lipoproteins in the pathogenesis of coronary atherosclerosis has been well defined. 1 Restenosis after coronary angioplasty is often described as a form of accelerated atherosclerosis due to phenotypic modification and proliferation of medial muscle myocytes. 2 A few recent studies investigated the role of lipoproteins in restenosis, but the results were conflicting. 3–5 Modification of lipoprotein profile can halt the progression and even induce regression of coronary atherosclerosis 6,7 ; whether it can also decrease the rate of restenosis is not clear. In this investigation, we examined the effect of the different lipoprotein fractions on the development of restenosis, using the absolute and relative amounts of late loss of luminal diameter as a continuous measure of restenosis.

C oronary stents were introduced in an attempt to overcome 2 main limitations of balloon angioplasty: acute occlusion and restenosis. Numerous reports showed that different stent designs are useful.1-3 The main problem of currently available metallic stents is the tendency for thrombotic occlusion. This is a serious complication that can cause acute myocardial infarction and death.4 Chronic anticoagulation decreases the occlusion rate but causes complications at the puncture site and increases the length of hospitalization and cost of the procedure.5 Recent abstracts have suggested that anticoagulation might not be necessary when stents are deployed with high-pressure balloon inflation with or without intravascular ultrasound proof of optimal deployment.6,7 This report will describe our initial experience with PalmazSchatz stents with emphasis on the risk of thrombotic occlusion. . . . Coronary stents were successfully deployed in 50 of 52 patients (96%). In the 2 patients in whom the stent was not deployed, the procedure was successfully completed with balloon dilatation. The mean age was 60 + 11 years, most patients (45) were men, and the indication for cardiac catheterization was stable angina in 29 and unstable or postmyocardial infarction angina in 21 patients. Twenty-seven stents were implanted to overcome acute closure or severe dissection that would have otherwise required emergency bypass surgery, 14 were implanted in lesions with previous restenosis, and in 11 patients stents were implanted electively as the initial therapy (mainly in saphenous vein grafts). Thirty-nine stents were implanted in native coronary vessels and 13 in saphenous vein grafts. Stents were deployed after target lesion predilatation using a balloon that matched the size of the normal artery. Stents were manually crimped on a balloon (usually 0.5 mm larger than the original balloon) and were deployed using 30-second inflation to 6 to 8 atm. Patients were treated with intravenous dextran for 24 hours and a combination of aspirin and dipyridamole. Treatment with warfarin was begun on the day of the procedure and was continued for 3 months, with a target international normalized ratio of 3 to 4. Heparin infusion was maintained with a target partial thromboplastin time of 80 to 100 seconds for >5 days, and for 1 day after target prothrombin level was achieved. Sheaths were removed from the femoral artery the morning after the

The importance of timing of intravenous streptokinase (SK) administration in patients with acute myocardial infarction (AMI) was evaluated. Intravenous SK, 750,000 U, was administered within 4 hours of the onset of ischemic chest pain to 72 consecutive patients having their first AMI. Six days later, cardiac catheterization was performed to calculate global ejection fraction (EF), and computer-derived infarct-related regional EF and dysfunction index were also determined; electrocardiograms were recorded, from which QRS scores could be calculated to estimate infarct size. Of 19 patients who had an anterior AMI, 12 (63%) who received intravenous SK within 2 hours after onset of pain sustained only minimal damage in terms of global EF, infarct-related EF, dysfunction index and QRS score. All 10 patients who received SK 2 to 4 hours after pain onset had large infarcts (p less than 0.001). Of the former group, 11 of 12 patients (91%) whose pain was relieved within 1.5 hours of intravenous SK administration (presumably due to successful reperfusion) had a good outcome, whereas all 7 whose pain lasted longer did poorly (p less than 0.001). Furthermore, among patients with anterior AMI, 11 of 14 (79%) whose pain was relieved within 3.5 hours of onset had small infarcts, compared with none of the 12 patients whose pain lasted longer (p less than 0.0001). In inferior AMI, the critical time between onset of pain and initiation of intravenous SK was 1.5 hours (p less than 0.05). The timing of initiation of thrombolytic therapy and the total pain duration are critical in determining outcome in AMI, and time intervals vary depending on infarct localization.