Incidence, management, and outcomes of cardiac tamponade during transcatheter aortic valve implantation: a single-center study.

OBJECTIVES: The aim of this study was to explore the incidence, causes, and outcomes of cardiac tamponade in patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: Use of TAVI is increasing, but the procedure is vulnerable to complications, given the cohort of patients. Cardiac tamponade is a possible complication, and there is a scarcity of data on the incidence and outcomes of cardiac tamponade during TAVI. METHODS: All patients who sustained cardiac tamponade during or post-TAVI between 2007 and 2012 were included in the study. RESULTS: Of 389 patients who underwent TAVI, 17 (4.3%) had cardiac tamponade. The mean age was 82.3 ± 3.7 years, and most were women (n = 12, 70.6%). Causes of cardiac tamponade were right ventricular perforation by temporary pacemaker (9 patients, 52.9%), annular rupture or aortic dissection (4 patients, 23.5%), and tear in the left ventricular free wall caused by Amplatz stiff wire or catheters (4 patients, 23.5%). Mortality occurred in 4 patients (23.5%), and all had tamponade caused by injury to the high-pressured left-sided circulation (left ventricle and aorta). Most patients (n = 14, 82.4%) sustained cardiac tamponade during the procedure-2 patients (11.7%) within 24 h, and 1 patient after 24 h. CONCLUSIONS: Cardiac tamponade during TAVI is not frequent but is associated with high mortality rates especially when left-sided structures are involved. Meticulous handling of the equipment and improvements in the safety of currently used devices could further reduce the occurrence of this complication.

Long-term outcomes following drug-eluting stent implantation in unprotected left main bifurcation lesions.

BACKGROUND: The safety and efficacy of drug-eluting stents (DES) implantation in unprotected left main (LM) bifurcation lesions has yet to be determined. The aim of the present report was to evaluate the long-term outcome following implantation of DES in unprotected LM bifurcation lesions. METHODS: We identified 70 consecutive patients treated with DES in unprotected LM bifurcation lesions from April 2003 to January 2005. Of them, 42 patients were treated with sirolimus-eluting stent (SES) and 28 patients were treated with paclitaxel-eluting stent (PES). RESULTS: Stents to the left anterior descending and to the circumflex were implanted in 62 patients. During 1-year follow-up, 3 (4.3%) patients died of cardiac causes. One of them had myocardial infarction and adjudicated as possibly due to stent thrombosis. Angiographic follow-up was available in 80% of patients. The per lesion restenosis rate was 13.4% in the entire cohort, of which 10.7% occurred in lesions treated with SES and 16.1% in those treated with PES (P = 0.58). All restenosis was focal and occurred in the lesions treated with a stent with stent size to post-procedural reference vessel diameter ratio < 1.0 (17.6% vs 0, P = 0.04). The per patient target lesion revascularization rate at 1 year was 17.1%. One year survival free from major adverse cardiac events was 77.1%. CONCLUSIONS: Treatment of LM bifurcation lesions using DES is a safe and feasible way with a low one-year mortality. The need for revascularization in 17% of patients demands for improvement.

Long-term outcomes after stenting of bifurcation lesions with the "crush" technique: predictors of an adverse outcome.

OBJECTIVES: The purpose of this study was to evaluate predictors of an adverse outcome after "crush" bifurcation stenting. BACKGROUND: The "crush" technique is a recently introduced strategy with limited data regarding long-term outcomes. METHODS: We identified 231 consecutive patients treated with drug-eluting stent implantation with the "crush" technique for 241 de novo bifurcation lesions. Clinical follow-up was obtained in 99.6%. RESULTS: The in-hospital major adverse cardiac event (MACE) rate was 5.2%. At 9 months, 10 (4.3%) patients had an event consistent with possible post-procedural stent thrombosis. Survival free of target lesion revascularization (TLR) was 90.3%; the only independent predictor of TLR was left main stem (LMS) therapy (odds ratio [OR] 4.97; 95% confidence interval [CI] 2.00 to 12.37, p = 0.001). Survival free of MACE was 83.5% and independent predictors of MACE were LMS therapy (OR 3.79; 95% CI 1.76 to 8.14, p = 0.001) and treatment of patients with multivessel disease (OR 4.21; 95% CI 0.95 to 18.56, p = 0.058). Angiographic follow-up was obtained in 77% of lesions at 8.3 +/- 3.7 months. The mean late loss of the main vessel and side branch were 0.30 +/- 0.64 mm and 0.41 +/- 0.67 mm, respectively, with binary restenosis rates of 9.1% and 25.3%. Kissing balloon post-dilation significantly reduced the side branch late lumen loss (0.24 +/- 0.50 mm vs. 0.58 +/- 0.77 mm, p < 0.001). CONCLUSIONS: The crush technique of bifurcation stenting with drug-eluting stents is associated with favorable outcomes for most lesions; however, efficacy appears significantly reduced in LMS bifurcations, and further research is needed before the technique can be routinely recommended in this group. Furthermore, the incidence of possible stent thrombosis is of concern and requires further investigation. Kissing balloon post-dilatation is mandatory to reduce side branch restenosis.

[Percutaneous coronary interventions in elderly patients: clinical indications and adjunctive medical treatment. The Italian Drug Evaluation in Angioplasty (IDEA) study]. / Procedure interventistiche coronariche percutanee in pazienti anziani: indicazioni cliniche e terapie farmacologiche concomitanti. Lo studio Italian Drug Evaluation in Angioplasty (IDEA).

BACKGROUND: Specific guidelines for interventional cardiology in elderly patients are not available, and it appears that aged patients are treated more conservatively. Nevertheless data on the real clinical practice are lacking. The aim of the study was to describe different therapeutic strategies in elderly patients enrolled in the Italian Drug Evaluation in Angioplasty (IDEA) study. METHODS: The IDEA study is a registry of consecutive percutaneous coronary interventions (PCI) performed from September 15 to 29, 2003, at 79 Italian cath-labs. RESULTS: Out of 1517 consecutive PCI patients, 491 (32%) were aged > or = 70 years. Compared to younger patients, those > or = 70 years old showed more frequently (p < 0.001) renal insufficiency (10.4 vs 4.4%), peripheral vasculopathy (18 vs 6.9%), history of stroke (7.3 vs 3.3%) or previous surgical coronary revascularization (15 vs 7.5%) and multivessel disease (61 vs 49%). In patients aged > or = 70 years, acute coronary syndrome was the more frequent clinical indication for PCI (54 vs 49% in patients < 70 years, p = 0.05). Globally, stent use was 89% with no differences related to the patients' age. Drug-eluting stents were used in 21% of the procedures in elderly patients and in 22% in younger patients. Use of glycoprotein IIb/IIIa receptor antagonists in acute coronary syndrome was not correlated with the patients' age; nevertheless in elderly patients with acute myocardial infarction these drugs were less used during primary angioplasty compared to younger patients (48 vs 72%, p = 0.001). In-hospital mortality was higher in patients aged > or = 70 years (2.9 vs 0.9%, p = 0.004), particularly in patients treated for acute coronary syndromes (5.5 vs 1.4%, p = 0.002). In these patients, more bleeding complications (7.1 vs 3.9%, p < 0.001) and heart failure (5.5 vs 1.6%, p = 0.004) were observed. CONCLUSIONS: Compared to younger patients, elderly patients enrolled in the IDEA study had a higher risk profile and higher in-hospital morbidity and mortality. Except for a lower use of glycoprotein IIb/IIIa receptor antagonists for acute myocardial infarction, no discriminations were observed in elderly patients in terms of clinical indications, antiplatelet therapy and drug-eluting stent use.

Percutaneous saphenectomy: a potentially dreadful complication of cutting balloon angioplasty in saphenous vein grafts.

Vessel perforation is an uncommon but potentially life-threatening complication of percutaneous coronary intervention and is often associated with the use of atheroablative devices. While effective management means are currently available, such as PTFE-covered stent, pericardiocentesis, and perfusion balloon, a timely and skillful approach is of paramount importance to solve this dreadful complication. We hereby describe a case of saphenous vein graft (SVG) perforation occurring after cutting balloon angioplasty for in-stent restenosis. Despite the immediate occurrence of cardiac arrest due to massive extravasation of contrast in the mediastinum with pericardial tamponade, deep catheter intubation enabled the deployment of two PTFE-covered stents and subsequent sealing of the leak with repeated inflation of a perfusion balloon, while hemopericardium was drained by pericardiocentesis. This clinical vignette emphasizes the role of optimal backup in order to deploy life-saving devices and successfully manage life-threatening pericardial tamponade due to SVG rupture.

New technique to seal a long giant coronary aneurysm with PTFE-covered stents: a case report.

We report a case with a large aneurysm of right coronary artery (RCA) associated with coronary artery disease. The aneurysm was sealed with two PTFE-covered stents using a sequential technique from proximal to distal to overcome the lack of long PTFE-covered stents and existence of complex coronary anatomy. A bare metal stent was subsequently deployed to treat a lesion in the mid part of RCA. At 4-month follow-up, aneurysm was completely sealed and no restenosis occurred. Usage of sequential PTFE-covered stents enables treatment of large coronary artery aneurysms.

Clinical outcome following aleatory implantation of paclitaxel-eluting or sirolimus-eluting stents in complex coronary lesions.

We compared the clinical efficacy of paclitaxel-eluting stents (PESs) and sirolimus-eluting stents (SESs) in a contemporary cohort of patients who had complex lesions. We collected data on 9-month outcomes in 529 patients (281 in the PES group and 248 in the SES group) whose de novo lesions were treated with drug-eluting stents. The end point was per-patient in-hospital and follow-up major adverse cardiac events, which were defined as a composite of death, myocardial infarction, and target vessel revascularization, including target lesion revascularization. There were no in-hospital deaths or repeat revascularizations; however, 5.7% of the PES group and 2% of the SES group developed a myocardial infarction (p = 0.04). At a median follow-up of 10.6 months, the rate of major adverse cardiac events was similar between groups (18.1% vs 21%, adjusted hazard ratio 0.85, 95% confidence interval 0.57 to 1.25), without any difference in the occurrence of death or myocardial infarction. Diabetes and total stent length were independent predictors of major adverse cardiac events. Propensity analysis confirmed the similarity between devices (hazard ratio 0.87, 95% confidence interval 0.62 to 1.25). Most restenoses were focal and only 2 patients required surgical revascularization. In conclusion, implantation of drug-eluting stents in complex lesions was associated with favorable results and most patients remained free from surgical revascularization at follow-up. Overall, the 2 available stent platforms had similar performance characteristics.

Clinical and angiographic outcome after implantation of drug-eluting stents in bifurcation lesions with the crush stent technique: importance of final kissing balloon post-dilation.

OBJECTIVES: The purpose of this research was to evaluate the long-term outcomes after implantation of drug-eluting stents (DES) in bifurcation lesions with the "crush" technique. BACKGROUND: The long-term outcome of "crush" stenting technique has yet to be determined. METHODS: We identified 181 consecutive patients who were treated with DES with the "crush" stent technique from April 2002 to April 2004. Based on the usage of final kissing balloon post-dilation (FKB), the patients were divided into an FKB group (n = 116) and a non-FKB group (n = 65). RESULTS: Clinical follow-up at nine months was available in all patients, and angiographic follow-up in 80% of patients. Three cases (1.7%) of intraprocedural stent thrombosis and five (2.8%) cases of postprocedural stent thrombosis occurred. Restenosis rate of the main branch in the entire cohort lesions was 11.5%. Restenosis rate of the side branch was lower in the FKB group than that in the non-FKB group (11.1% vs. 37.9%, p < 0.001). The target lesion revascularization (TLR) rate for all patients was 14.9%. The lack of FKB was a predictor for TLR (hazard ratio [HR] 4.17; 95% confidence interval [CI] 1.30 to 14.3, p = 0.02). Diabetes was also a predictor for TLR (HR 1.79; 95% CI 1.14 to 2.80, p = 0.01). Premature discontinuation of dual antiplatelet therapy (odds ratio [OR] 16.8; 95% CI 1.31 to 159.5, p = 0.03) and age (OR 1.10; 95% CI 1.00 to 1.21, p = 0.048) was associated with the occurrence of postprocedural stent thrombosis. CONCLUSIONS: Compared to the absence of FKB, the "crush" stenting technique with FKB appears to be associated with more favorable long-term outcomes. When utilizing the "crush" stenting technique, FKB is mandatory.

Multiple overlapping drug-eluting stents to treat diffuse disease of the left anterior descending coronary artery.

OBJECTIVES: We sought to determine the safety and efficacy of using multiple overlapping drug-eluting stents (DES) in patients with diffuse left anterior descending coronary artery (LAD) disease. BACKGROUND: Diffuse LAD disease represents a therapeutic challenge. Results after coronary artery bypass surgery are suboptimal, whereas the use of bare metal stents is limited by high rates of restenosis. The introduction of DES prompted treatment of long diffuse disease with multiple overlapping stents. METHODS: All consecutive patients with de novo diffuse LAD disease treated with more than 60-mm long DES from April 2002 to March 2004 were analyzed. RESULTS: The study population consisted of 66 patients. Thirty-nine patients were treated with sirolimus-eluting stents (SES), average length 84 +/- 22 mm, and 27 patients with paclitaxel-eluting stents (PES), average length 74 +/- 14 mm. The number of stents implanted per patient was 2.8 +/- 0.7, whereas the mean total stent length for the LAD treatment was 80 +/- 20 mm. Angiographic as well as procedural success was achieved in 95% of cases. Eleven (16.6%) patients had in-hospital non-Q-wave myocardial infarction (five SES and six PES), and one patient developed intraprocedural stent thrombosis. All patients had clinical follow-up, and 52 patients (79%) had an angiographic follow-up at six months. Hierarchical major adverse cardiac event rate was 15% (7.5% for SES and 7.5% for PES). No patients died, one patient had non-Q-wave myocardial infarction (non-index vessel), and 10 patients (15%) underwent target vessel revascularization. CONCLUSIONS: The implantation of multiple overlapping DES in patients with a diffusely diseased LAD is relatively safe and associated with good midterm clinical outcomes.

Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents.

CONTEXT: Traditionally, stent thrombosis has been regarded as a complication of percutaneous coronary interventions during the first 30 postprocedural days. However, delayed endothelialization associated with the implantation of drug-eluting stents may extend the risk of thrombosis beyond 30 days. Data are limited regarding the risks and the impact of this phenomenon outside clinical trials. OBJECTIVE: To evaluate the incidence, predictors, and clinical outcome of stent thrombosis after implantation of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice. DESIGN, SETTING, AND PATIENTS: Prospective observational cohort study conducted at 1 academic hospital and 2 community hospitals in Germany and Italy. A total of 2229 consecutive patients underwent successful implantation of sirolimus-eluting (1062 patients, 1996 lesions, 2272 stents) or paclitaxel-eluting (1167 patients, 1801 lesions, 2223 stents) stents between April 2002 and January 2004. INTERVENTIONS: Implantation of a drug-eluting stent (sirolimus or paclitaxel). All patients were pretreated with ticlopidine or clopidogrel and aspirin. Aspirin was continued indefinitely and clopidogrel or ticlopidine for at least 3 months after sirolimus-eluting and for at least 6 months after paclitaxel-eluting stent implantation. MAIN OUTCOME MEASURES: Subacute thrombosis (from procedure end through 30 days), late thrombosis (>30 days), and cumulative stent thrombosis. RESULTS: At 9-month follow-up, 29 patients (1.3%) had stent thrombosis (9 [0.8%] with sirolimus and 20 [1.7%] with paclitaxel; P = .09). Fourteen patients had subacute thrombosis (0.6%) and 15 patients had late thrombosis (0.7%). Among these 29 patients, 13 died (case fatality rate, 45%). Independent predictors of stent thrombosis were premature antiplatelet therapy discontinuation (hazard ratio [HR], 89.78; 95% CI, 29.90-269.60; P<.001), renal failure (HR, 6.49; 95% CI, 2.60-16.15; P<.001), bifurcation lesions (HR, 6.42; 95% CI, 2.93-14.07; P<.001), diabetes (HR, 3.71; 95% CI, 1.74-7.89; P = .001), and a lower ejection fraction (HR, 1.09; 95% CI, 1.05-1.36; P<.001 for each 10% decrease). CONCLUSIONS: The cumulative incidence of stent thrombosis 9 months after successful drug-eluting stent implantation in consecutive "real-world" patients was substantially higher than the rate reported in clinical trials. Premature antiplatelet therapy discontinuation, renal failure, bifurcation lesions, diabetes, and low ejection fraction were identified as predictors of thrombotic events.

Treatment of saphenous vein graft lesions with drug-eluting stents: immediate and midterm outcome.

OBJECTIVES: The purpose of the present report was to evaluate clinical and angiographic outcomes of drug-eluting stent (DES) implantation in saphenous vein graft (SVG) lesions. BACKGROUND: The safety and efficacy of DES implantation for the treatment SVG lesions remains uncertain. METHODS: We evaluated in-hospital and six-month outcomes in 61 consecutive patients treated with DES in SVG lesions from March 2002 to March 2004 (DES group), as compared to 89 consecutive patients treated with bare-metal stents (BMS) in the 24 months immediately before the introduction of DES (BMS group). Major adverse cardiac events (MACE) including death, myocardial infarction, target lesion revascularization (TLR), and target vessel revascularization (TVR) were recorded in-hospital and at six-month follow-up. RESULTS: The rate of in-hospital MACE was similar between the two groups (6.6% vs. 5.6%, p = 1.0). Cumulative MACE at six months was 11.5% in the DES group and 28.1% in the BMS group (p = 0.02). The DES group had a significantly lower incidence of in-segment restenosis (10.0% vs. 26.7%, p = 0.03), TLR (3.3% vs. 19.8%, p = 0.003), and TVR (4.9% vs. 23.1%, p = 0.003). By Cox regression analysis, diabetes (hazard ratio [HR]: 3.03; 95% confidence interval [CI]: 1.33 to 6.90; p = 0.008), usage of BMS (HR: 2.53; 95% CI: 1.07 to 5.97; p = 0.03), and age of SVG (HR: 1.10; 95% CI: 1.02 to 1.19; p = 0.02) were identified as predictors of MACE at six-month follow-up. CONCLUSIONS: Compared to BMS implantation, DES implantation in SVG lesions appears safe with favorable and improved mid-term outcomes.

Immediate and mid-term outcomes of sirolimus-eluting stent implantation for chronic total occlusions.

AIMS: To evaluate the outcomes of sirolimus-eluting stent (SES) implantation for the treatment of chronic total occlusion (CTO). METHODS AND RESULTS: We identified 122 patients who underwent revascularization in CTO lesions with SES from April 2002 to April 2004 (SES group). A control group was composed of 259 consecutive patients with CTO lesions treated with bare metal stents (BMS) in the 24 months immediately before the introduction of SES (BMS group). At 6-month follow-up, the cumulative rate of major adverse cardiac events (MACE) was 16.4% in the SES group and 35.1% in the BMS group (P<0.001). The incidence of restenosis was 9.2% in the SES group and 33.3% in the BMS group (P<0.001). The need for revascularization in the SES group was significantly lower, both target lesion revascularization (7.4 vs. 26.3%, P<0.001) and target vessel revascularization (9.0 vs. 29.0%, P<0.001). BMS implantation (HR: 2.97; 95% CI: 1.80-4.89; P<0.001), lesion length (>20 mm) (HR: 2.02; 95% CI: 1.37-2.99; P=0.0004), and baseline reference vessel diameter (>2.8 mm) (HR: 0.62; 95% CI: 0.42-0.92; P=0.02) were identified as predictors of MACE during 6-month follow-up. CONCLUSION: Compared with BMS, SES implantation in CTO lesions appears to be effective in reducing the incidence of restenosis and the need for revascularization at 6 months.

Treating chronic total occlusions using subintimal tracking and reentry: the STAR technique.

Successful recanalization of coronary total occlusions (CTOs) remains an area where improvements are needed. We propose an approach similar to the one utilized in treating some peripheral artery occlusions and aimed to create a subintimal dissection with distal reentry. A 0.014' hydrophilic wire with a J-configuration is utilized for this purpose. We applied this technique to CTO of native coronaries in 31 patients where previous attempts failed in 21 of them (67%). The right coronary artery (RCA) was the index vessel in 87% of patients. Recanalization of the vessel and of most of distal branches was achieved in 21 patients; patency of at least one major distal branch was achieved in 9 patients. Drug-eluting stents (DESs) were implanted in 53% of patients. Three patients had intraprocedural vessel perforation without consequences. Five patients (16%) had in-hospital non-Q-wave myocardial infarction. No other adverse events occurred at a mean follow-up of 5.1 +/- 3.7 months except for one noncardiac death. Angiographic follow-up was performed in 21 (67%) patients and 53% of them developed restenosis. Reintervention on the target vessel was performed in 11 patients (52%). Complete success with the procedure was originally obtained in 8 of the 10 patients who did not develop restenosis and in 8 of them DESs were originally implanted. This technique appears a promising approach to recanalize difficult total occlusions, particularly the ones localize on the RCA, which has the most important side branches located distally.

Results and follow-up after implantation of four or more sirolimus-eluting stents in the same patient.

The aim of this study was to assess the safety and effectiveness of > or =4 sirolimus-eluting stent (SES; Cypher, Cordis, Johnson and Johnson) implantation. The safety of implantation of > or =4 SESs in the same patient and setting has not been established. Furthermore, it has been hypothesized that sirolimus administration with the use of multiple stents may diminish the platelet inhibitory effects of clopidogrel and may trigger drug-drug interactions. We identified 96 consecutive patients (96 procedures) who underwent implantation of > or =4 SESs in 365 lesions (438 stents) during the same procedure. All patients received aspirin indefinitely and clopidogrel or ticlopidine for at least 1 year postprocedure; 57% and 47% of the patients were on calcium channel blocker and statin therapy, respectively. All stents were successfully deployed and glycoprotein IIb/IIIa inhibitors were used in 50% of the procedures. There were no in-hospital deaths, Q-wave myocardial infarction (MI), urgent bypass surgery, or repeat percutaneous coronary intervention; 18 patients (19%) suffered non-Q-wave MI (defined as CK-MB elevation >3 times the upper limit of normal). At 30-day follow-up, there was one (1%) subacute thrombosis resulting in target lesion revascularization. At mean follow-up time of 15.4 +/- 6.2 months, the frequency of target lesion revascularization, target vessel revascularization, and major adverse cardiac event rates were 12%, 16%, and 18%, respectively. No other notable clinical events that might have been attributed to the possible drug-drug interactions or discontinuation of concomitant antithrombotic, statin, or calcium channel blocker therapy were reported. Multiple (> or =4) SES implantation appears safe with no increase in major adverse cardiac events.

In-hospital and nine-month outcome of treatment of coronary bifurcational lesions with sirolimus-eluting stent.

Between April 2002 and May 2004, 174 consecutive patients who underwent percutaneous coronary intervention of bifurcational lesions with sirolimus-eluting stents were identified. Two strategies were used: stenting only 1 branch (group 1S, n = 57) or stenting both branches (group 2S, n = 117). The incidence of major adverse cardiac events was evaluated in the hospital and at 9-month follow-up. There were no statistically significant differences between the 2 groups with regard to the incidence of target lesion revascularization (5.4% vs 8.9%, p = 0.76), target vessel revascularization (5.4% vs 11.1%, p = 0.51), and cumulative major adverse cardiac events (18.9% vs 23.3%, p = 0.76) at 9 months.

Preliminary experience with the Frontrunner coronary catheter: novel device dedicated to mechanical revascularization of chronic total occlusions.

The novel device Frontrunner coronary catheter (FCC), dedicated to recanalization of chronic total occlusions (CTOs), relies on blunt microdissections inside the plaque, allowing passage of guidewire through the lesion and adjunctive angioplasty. In order to evaluate efficacy and safety of recanalization using the FCC device, we included patients with de novo or restenotic CTOs in a native coronary artery with prior failure using a guidewire or considered unsuitable for guidewire attempt in which the FCC was attempted first. Between October 2000 and June 2003, 50 patients with 50 CTOs were included in the study. Thirty-two patients had prior failure with a mechanical wire. Device and angiographic success were obtained in 25 (50%) occlusions: 53% in lesions with prior guidewire failure and 44% when FCCs were attempted first (P = 0.8). During the first year of experience, angiographic success was 42% (5 occlusions) and in the third year 75% (12 occlusions; P = 0.12). Coronary perforation occurred in nine (18.0%) patients, leading to tamponade in two (4%) patients. Perforations occurred in 5 out of 12 attempted patients during the first year and in 4 out of 38 patients in the following period (41.7% vs. 10.5%; P = 0.04). Serious adverse events occurred in five (10%) patients within 30-day follow-up. Four non-Q-wave myocardial infarctions occurred in hospital (clinical success 42%) and one death 7 days after the index procedure. The use of FCC increases the success to open chronic total occlusions refractory to mechanical guidewires or that were considered unsuitable for an attempt with a guidewire. The risk of coronary perforation due to FCC use is relatively high and it can decrease with experience.

Is overdilatation of 3.0 mm sirolimus-eluting stent associated with a higher restenosis rate?

We evaluated the safety and effectiveness of postdilating a 3.0 mm sirolimus-eluting stents (SESs; six cells) with a 3.5-4.0 mm balloon. We identified 254 consecutive patients who underwent percutaneous coronary interventions using SESs with a nominal diameter of 3.0 mm (six cells). Patients were divided into two groups based on whether they were subsequently postdilated with a 3.0 mm (group 1: 168 patients, 251 lesions) or a 3.5-4 mm balloon (group 2: 86 patients, 102 lesions). There were no significant differences regarding the incidence of in-hospital and long-term follow-up. Angiographic follow-up was available in 72% and 74% of groups 1 and 2, respectively. The two groups had no significant differences regarding late lumen loss (0.51 +/- 0.36 vs. 0.52 +/- 0.33; P = 0.3) and binary restenosis rates (10.7% vs. 8.8%; P = 0.1). Six-month clinical follow-up was available in all patients. At long-term follow-up (mean: 10.6 +/- 3.7 for group 1 and 11.3 +/- 3.9 months for group 2), there were no significant differences between the two groups regarding major adverse cardiac events (8.9% vs. 9.2%; P = 0.9). Implantation of a 3.0 mm SES with postdilation with a 3.5-4 mm balloon did not result in any significant difference in complications, in-hospital non-Q-wave myocardial infarction, binary restenosis, or target lesion revascularization. These data should lessen concern that overdilation may dilute the beneficial effects of SESs.

Clinical and angiographic outcome after sirolimus-eluting stent implantation in aorto-ostial lesions.

OBJECTIVES: This observational study evaluated the clinical and angiographic outcomes of patients with aorto-ostial coronary artery disease treated with sirolimus-eluting stents (SESs) or with bare metal stents (BMSs). BACKGROUND: The safety and effectiveness of SESs for the treatment of aorto-ostial lesions have not been demonstrated. METHODS: We identified 82 consecutive patients who underwent percutaneous coronary interventions in 82 aorto-ostial lesions using the SES (32 patients) or BMS (50 patients) and compared the two groups of patients. The incidence of major adverse cardiac events (MACE), including death or Q-wave myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR), were recorded in-hospital and at a 10-month follow-up. RESULTS: All stents were implanted successfully. There were no statistically significant differences regarding major in-hospital complications between the two groups. At 10-month follow-up, two (6.3%) patients in the SES group and 14 (28%) patients in the BMS group underwent TLR (p = 0.01); MACE were less frequent in the SES group compared to the BMS group (19% vs. 44%, p = 0.02). Angiographic follow-up showed lower binary restenosis rates (11% vs. 51%, p = 0.001) and smaller late loss (0.21 +/- 0.31 mm vs. 2.06 +/- 1.37 mm, p < 0.0001) in the SES group. CONCLUSIONS: The main finding of our study is that, compared to the BMS, implantation of the SES in aorto-ostial lesions appears safe and effective, with no increase in major in-hospital complications and a significant improvement in restenosis and late event rates at 10-month follow-up.

Effectiveness of sirolimus-eluting stent implantation for treatment of in-stent restenosis after brachytherapy failure.

The impact of the use of sirolimus-eluting stents (SESs) in the treatment of in-stent restenosis in previously irradiated sites has not been adequately evaluated. Fifteen consecutive patients who underwent percutaneous coronary interventions using SESs in lesion sites previously intervened with intracoronary radiation therapy were identified. All stents were implanted successfully, and there were no major in-hospital complications. At 30-day follow-up, there was 1 case of subacute thrombosis that led to target lesion revascularization (TLR). At 6 months, 2 patients underwent TLR because of recurrent angina with angiographic restenosis, and 1 patient underwent target vessel revascularization distally to the SES site; no other major adverse cardiac events occurred at long-term follow-up (mean 17 +/- 8 months).