Evolution, Predictors, and Neurocognitive Effects of Silent Cerebral Embolism During Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to assess the characteristics, predictors, evolution, and neurocognitive effects of silent cerebral ischemic lesions (SCILs). BACKGROUND: Most patients undergoing transcatheter aortic valve replacement (TAVR) develop SCILs detectable on magnetic resonance imaging (MRI). The natural history and clinical relevance of SCILs are not well established. METHODS: Cerebral MRI was performed within 7 days before TAVR to assess baseline status and age-related white matter change score. MRI was repeated post-operatively to assess the occurrence, location, number, and dimensions of SCILs. Patients developing SCILs underwent a third MRI examination at 3- to 5-month follow-up. A neurocognitive evaluation was performed before TAVR, at discharge, and at 3-month follow-up. RESULTS: Of the 117 patients enrolled, 96 underwent post-procedural MRI; SCILs were observed in 76% of patients, distributed in all vascular territories, with a median number of 2 lesions, a median diameter of 4.5 mm, and a median total volume of 140 mm3. Independent predictors of SCIL occurrence were higher baseline age-related white matter change score and the use of self-expanding or mechanically expanded bioprostheses. Among 47 patients who underwent follow-up MRI, only 26.7% of post-procedural SCILs evolved into gliotic scar. SCIL occurrence was associated with a more pronounced transient neurocognitive decline early after TAVR and with lower recovery at follow-up. CONCLUSIONS: SCILs occur in the vast majority of patients undergoing TAVR and are predicted by more diffuse white matter damage at baseline and by the use of non-balloon-expandable prostheses. Although most SCILs disappear within months, their occurrence has a limited but significant impact on neurocognitive function.

Impact of female sex on long-term outcomes in patients with ST-elevation myocardial infarction treated by primary percutaneous coronary intervention.

BACKGROUND: Conflicting information exists about whether sex differences affect long-term outcomes in patients undergoing primary percutaneous coronary intervention (PCI). METHODS: This retrospective study enrolled consecutive patients with ST-elevation myocardial infarction undergoing primary PCI within 24 hours from symptom onset. Hazard ratios (HRs) of events with 95% confidence interval (CI) were calculated in the overall population and in a propensity score matched cohort of women and men. RESULTS: Among 481 patients, median age 66 years old, 138 (28.7%) were women. Women were older than men (72 vs 63 years, P<0.001), had a higher prevalence of hypertension (68% vs 54%, P=0.006), diabetes (27% vs 19%, P=0.04), and Killip class≥3 at admission (19% vs 10%, P=0.007). After a median follow-up of 1041 days women experienced a significant higher incidence of the composite of death, nonfatal myocardial infarction, and hospitalization for heart failure (31.9% vs 18.4%, unadjusted HR 1.86; 95% CI, 1.26-2.74; P=0.002), driven mainly by heart failure (unadjusted HR 2.47; 95% CI, 1.12-5.41; P=0.024), without significant differences in death (unadjusted HR 1.49; 95% CI, 0.88-2.53; P=0.13), or nonfatal myocardial infarction (unadjusted HR 1.59; 95% CI, 0.78-3.27; P=0.19) and no increase in target lesion revascularization (9.4% vs 12.5%, unadjusted HR 0.77; 95% CI, 0.42-1.44; P=0.42). After propensity score matching the hazard of the composite endpoint was largely attenuated (HR 1.32; 95% CI, 0.84-2.06; P=0.23). CONCLUSIONS: Women undergoing primary PCI experience worse long-term outcomes than men, but this difference is largely explained by their more adverse baseline cardiovascular profile.

"Gender paradox" in outcome after percutaneous coronary intervention with paclitaxel eluting stents.

AIMS: To evaluate in-hospital and long-term outcome of women undergoing percutaneous coronary intervention (PCI) with paclitaxel-eluting stents (PES) as compared to men and historic controls treated with bare metal stents. METHODS AND RESULTS: Eight-hundred and ten (810) consecutive patients (642 men and 168 women) with PES were analysed and also compared with 3,515 patients (2,811 men and 704 women) with at least one bare metal stent in the three years previous. In the PES group, women were significantly older than men (mean age of 68+/-10 vs. 63+/-10 years, p<0.001), with more diabetes (39.9 vs. 29.7%, p<0.05), smaller treated vessels (<2.5 mm in 34.9 vs. 24.8%, p=0.003), more left-anterior descending lesions (56.6 vs. 43.2%, p<0.001). More men had multivessel disease (78.8 vs. 62.5%, p<0,001), dyslipidaemia (73.2 versus 65.4%, p<0.05), smoking habit (74.3 versus 34.5%, p<0.001) or prior revascularisation (49.7 versus 36.1%, p<0.05). Compared to bare metal stents, similar higher risk features were recorded in women over time. No gender specific differences in in-hospital outcome were observed. At 12 months the rates of cardiac death, acute myocardial infarction (AMI) and late thrombosis were respectively 2.0%, 3.7% and 0% in women and 2.1%, 3.2%, and 1.2% in men (all p=NS). CONCLUSIONS: Albeit with worse baseline clinical and angiographic characteristics in women, very high immediate success rates and a positive outcome can be achieved in both sexes after PES.

Drug-eluting stents for the percutaneous treatment of the anastomosis of the left internal mammary graft to left anterior descending artery.

BACKGROUND: Data on the treatment of left internal mammary to left anterior descending artery (LIMA-to-LAD) anastomotic disease are scarce and not homogeneous. Both surgery and percutaneous interventions (PCI) have been attempted, but the most effective treatment has not yet been established. In particular, should PCI be performed, the role of stenting seems to be limited by less favorable results than in other subsets of lesions. OBJECTIVE: To assess the clinical impact of drug-eluting stent (DES) use in this particular subset of lesions. METHODS: We describe a cohort of patients treated with PCI on LIMA-to-LAD anastomoses, reporting acute 1-year clinical and angiographic outcomes. The clinical impact of DES use was evaluated as the requirement for target lesion revascularizations (TLR). RESULTS: Fifty-six consecutive patients were evaluated. Acute procedural success was achieved in 52 patients (92.8%). Plain balloon angioplasty allowed acute procedural success in 15 patients (28.8%), whereas stenting was required in 37 patients (71.2%) with suboptimal results or to treat complications. Bare-metal stents (BMS) were used in 17 and DES in 20 patients, without differences in acute results. One-year clinical follow-up was available in 96.1% of patients. TLR were needed in 17.3% of patients. No significant differences were detected in TLR rates after treatment with BMS and DES (26.6% vs. 25%; P=0.99). Two late stent thromboses were observed after DES deployment. CONCLUSION: PCI of the stenoses of LIMA-to-LAD anastomoses with DES did not provide any clinical improvement over BMS use in long-term outcomes; DES use was associated with some cases of late thrombosis.

Immediate removal of femoral-sheath following protamine administration in patients undergoing intracoronary paclitaxel-eluting-stent implantation.

BACKGROUND: Immediate sheath-removal using post-procedural reversal of heparin with protamine reduces groin complications, shortens bed rest and hospital stay after percutaneous coronary intervention (PCI) with bare-metal stents. No data are available with newer and possibly more thrombogenic paclitaxel-eluting stents (PES). AIM: We assessed the safety and efficacy of post-procedural protamine administration after successful coronary PES implantation in elective PCI and in patients with acute coronary syndromes (ACS). METHODS: A consecutive series of 291 patients received 0.5 mg of protamine per 100 units of heparin whenever the post-procedural ACT was > 180 seconds, followed by immediate removal of the sheath (protamine group). Outcomes were compared to a historic control group comprising 291 consecutive patients, who also underwent PCI with PES, but without reversal of anticoagulation by protamine (non protamine group). The incidence of post-procedural vascular complications and bleeding complications, as well as hospital stay, were compared; as were the incidence of major cardiac events at 24 h, 30 days and 6 months. RESULTS: The post-procedural bleeding complications were significantly higher in the non-protamine group. Vascular complications were also more frequent in patients who were not treated with protamine. Hospitalisation length was significantly lower in the protamine group than in the non-protamine group (13.6 +/- 7 h versus 20.41 +/- 3.9 h; p < 0.001). The protamine-group patients also had a significantly reduced bed rest (10.3 h +/- 5.6 h versus 18 h +/- 3.5 h; p < 0.001). During hospitalisation, after PES implantation, no deaths or acute stent thrombosis were observed in either group. The overall incidence of thrombosis and major adverse cardiac events at follow-up were similar in the two groups. CONCLUSIONS: Immediate heparin neutralisation by protamine after successful PES implantation appears to be safe and feasible, also in patients with ACS. Use of protamine and early sheath removal after PCI confers early deambulation and may significantly limit healthcare cost, reduce vascular complications, bedrest, delayed discharge and patient discomfort.

Comparison between drug-eluting stents and beta-radiation for the treatment of diffuse in-stent restenosis: clinical and angiographic outcomes.

BACKGROUND: Initial reports on drug-eluting stents (DES) for the treatment for in-stent restenosis (ISR) show very good outcomes. Nevertheless, few data are available on direct comparison with intracoronary brachytherapy (IBT). The aim of this study was to compare brachytherapy and DES in treatment of diffuse ISR. METHODS: One hundred forty-one consecutive patients with diffuse ISR were treated with IBT (68 patients; beta (90Sr/90Y) emitters) or with DES (73 patients; 32 with sirolimus-eluting and 41 with paclitaxel-eluting stents). Angiographic and clinical follow-up was scheduled within 9 months. RESULTS: The first 74 lesions were treated with IBT (group 1) and the latter 74 with DES (group 2). The two groups were well matched for clinical/angiographic characteristics. At follow-up, restenosis rates were 37.8% (28/74) in IBT group and 14.9% (11/74) in DES group (P = .0028). A diffuse pattern of recurrence was more frequent after IBT (20/74 vs 6/74, P = .005). A worse outcome after IBT was associated with the "edge effect," accounting for most failures. Recurrence within the original restenotic stent was similar in both groups (12.9% vs 14.9% in groups 1 and 2 respectively, P = .8). CONCLUSIONS: Drug-eluting stents are more effective than IBT with beta-irradiation in reducing recurrence rates after treatment of diffuse ISR. In case of failure, the pattern of restenosis is more benign after treatment with DES.

"Do least harm" philosophy may suffice for percutaneous coronary intervention in octogenarians.

BACKGROUND: Octogenarians represent one of the most rapidly expanding segments of the population and an ever growing number are undergoing percutaneous coronary intervention (PCI). A simplified approach with incomplete or "culprit-lesion" only PCI may be an option even in multivessel disease, to minimize periprocedural complications while still allowing a meaningful clinical recovery in patients with inherent functional limitations related to age itself. We tried to determine the effects of either complete or partial PCI on procedural and long-term outcome in a consecutive series of octogenarians. METHODS: In-hospital and 1-year clinical outcomes were collected in elderly patients treated with PCI between January 1998 and March 2004 in our institution. RESULTS: In a total of 165 octogenarians, 73 elderly patients (44%) underwent complete (COM) and 92 (56%) incomplete (INC) revascularization. Major in-hospital cardiac events were similar in the two subgroups. At 1-year follow-up 65% of patients in the COM and 68% in the INC group (P = ns) referred improvement in angina status and quality of life. Clinically driven repeat PCI was necessary in 16% of COM and 15% of INC patients. Recurrent PCI was mostly required to treat a restenotic index lesion in both groups, while only five patients in the INC group (5.4%) required PCI of a different lesion. CONCLUSIONS: Current PCI coronary techniques are safe and effective in octogenarians. Restenosis remains the main cause for recurrent events after bare metal stents. Percutaneous revascularization limited to the culprit lesion may suffice in most patients, with favorable clinical outcome at 1 year.

[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.

Poor outcome in patients treated with brachytherapy for diffuse in-stent restenosis. The role of additional stenting despite prolonged antiplatelet therapy.

BACKGROUND: Brachytherapy (IBT) has been the first effective treatment of in-stent restenosis (ISR). However, when IBT is associated with additional stenting, high rates of late thrombosis have been observed. Even though prolongation of a double antiplatelet therapy seems to have overcome this problem, studies analyzing whether additional stenting still remains a negative prognostic factor for restenosis are lacking. AIM: To evaluate outcomes of patients treated for ISR with or without additional stenting and IBT followed by prolonged antiplatelet therapy. METHODS: Seventy-seven consecutive patients treated with beta radiation in 89 lesions with ISR were analyzed according to the need for deploying additional stents: 73 lesions were treated without additional stents (Group 1) and 16 lesions with one or more new stents (Group 2) because of suboptimal results or flow-limiting dissections. Double antiplatelet therapy was administered for 12 months. An angiographic follow-up was scheduled after 6 months. P-values < 0.05 were considered significant. RESULTS: Restenosis rates were 31.5% (23/73) and 62.5% (10/16) in Group 1 (G1) and Group 2 (G2), respectively (p = 0.02). The two groups did not differ for late vessel thrombosis (8 in G1 and 2 in G2). In G2, high rates of recurrence were observed in the additional stent (6/16, 37.5%; p = 0.02 versus edge restenosis and in old stent recurrence in both G1 and G2). CONCLUSIONS: The association of additional stenting with brachytherapy in treatment of ISR is characterized by poor outcomes, even if a prolonged antiplatelet therapy has been administered. These results are related to high restenosis rates observed in the additional stent.

Evidence for a "gender paradox" in diabetic patients undergoing percutaneous coronary intervention: adverse preprocedural risk but favorable long-term clinical outcome in women.

BACKGROUND: The aim of this study was to assess the impact of gender on procedural and late clinical outcome in a large cohort of consecutive diabetic patients undergoing percutaneous coronary intervention (PCI) in a single center. METHODS: The study included a cohort of 542 consecutive diabetic patients (414 men, 128 women), undergoing PCI for stable and unstable angina. Clinical events were assessed every 6 months for a mean follow-up period of 24 months. RESULTS: Compared to men, women were older and less often smokers. Insulin requirement was present in a substantially higher percentage of women than men (27 vs 18%, p = 0.03). Presentation with stable angina was more frequent in women, whereas silent ischemia was more prevalent in men. Adverse baseline clinical and angiographic characteristics in women (smaller vessels and longer lesion lengths) were associated with a more frequent need for multiple coronary stenting (23 vs 15% women vs men, p < 0.001) and a higher incidence of peripheral complications (3.2 vs 1.2%, p = 0.049). However, there were no statistically significant gender-related differences in major in-hospital events. Long-term clinical outcome was similar with equivalent incidence of death (4.9 vs 5.3%, p = 0.8), nonfatal myocardial infarction (2.4 vs 4.5%, p = 0.1), need for surgical or repeat percutaneous revascularization between women and men. CONCLUSIONS: Diabetic patients show an increased rate of major adverse cardiac events and target vessel revascularization after PCI. In these patients, female gender is associated with higher procedural complexity and peripheral complications; however, long-term clinical outcome of diabetic women is similar to that of men.

Immediate and late results of coronary angioplasty in patients with severe left ventricular dysfunction.

BACKGROUND: Severe coronary artery disease in patients with a markedly depressed left ventricular function is associated with a poor prognosis. Even though coronary angioplasty (PTCA) has been offered as an alternative to bypass surgery, the role of PTCA in the treatment of patients with severe left ventricular dysfunction has not been well defined. The aim of the present study was to evaluate the immediate and long-term results in patients with severe left ventricular dysfunction < or = 35% who underwent PTCA. METHODS: One hundred and twenty-five patients with a left ventricular ejection fraction < or = 35% who underwent PTCA were analyzed. RESULTS: The mean left ventricular ejection fraction was 29.7%. Eighty-seven patients (69.6%) had multivessel disease and 41 (32.8%) had previous coronary artery bypass graft. Intra-aortic balloon pumping was used in 12% of cases. Angiographic success was achieved in 96% of patients. Complete revascularization was achieved in 56 patients (44.8%). Major complications occurred in 4% of the population and 2 patients died (1.6%). During the long-term follow-up re-PTCA due to angiographic restenosis was performed in 41 patients (34%); 12 patients (10.4%) died. The only parameter which significantly correlated with death was the presence of an occluded left anterior descending coronary artery not recanalized neither with PTCA nor with coronary artery bypass graft. CONCLUSIONS: These data suggest that PTCA may be an effective treatment for coronary artery disease in patients with left ventricular dysfunction and is associated with high procedural success rate and low complications; however, the long-term follow-up seems not to be influenced by the PTCA procedure.