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Objectives: To describe the incidence, predictors, and clinical impact of permanent pacemaker insertion (PPI) following transcatheter aortic valve replacement (TAVR) in women. Background: Data on pacemaker insertion complicating TAVR in women are scarce. Methods: The Women's International Transcatheter Aortic Valve implantation (WIN-TAVI) is a prospective registry evaluating the safety and efficacy of TAVR in women. We included patients without preprocedural pacemakers and divided them into two groups: (1) PPI and (2) no-PPI. We identified PPI predictors using logistic regression and studied its clinical impact on the Valve Academic Research Consortium (VARC)-2 efficacy and safety endpoints. Results: Out of 1019 patients, 922 were included in the analysis. Post-TAVR PPI occurred in 132 (14.3%) patients. Clinical and procedural characteristics were similar in both groups. Pre-existing right bundle branch block (RBBB) was associated with a high risk of post-TAVR PPI (OR 3.62, 95% CI 1.85–7.06, p < 0.001), while implantation of balloon-expandable prosthesis was associated with a lower risk (OR 0.47, 95% CI 0.30–0.74, p < 0.001). Post-TAVR PPI prolonged in-hospital stay by a median of 2 days (11 [9–16] days in PPI vs. 9 [7–14] days in no-PPI, p = 0.005), yet risks of VARC-2 efficacy and safety endpoints at 1 year were similar in both groups (adjHR 0.95, 95% CI 0.60–1.52, p = 0.84 and adjHR 1.22, 95% CI 0.83–1.79, p = 0.31, respectively). Conclusion: Pacemaker implantation following TAVR is frequent among women and is associated with pre-existing RBBB and valve type. PPI prolongs hospital stay, albeit without any significant impact on 1-year outcomes.

Objectives The aim of the present study was to define the feasibility and clinical impact of complying with national consensus recommendations on perioperative management of antiplatelet therapy in patients with coronary stents undergoing cardiac and noncardiac surgery. Background There are limited evidence-based recommendations on the perioperative management of antiplatelet therapy in stented patients undergoing surgery. Methods The recommendations provided by the national consensus document were applied in a multicenter, prospective registry of consecutive patients with prior coronary stenting undergoing any type of surgery at 19 hospitals in Italy. The primary end-point was in-hospital net adverse clinical events (NACE) represented by the composite of all-cause death, myocardial infarction, probable/definite stent thrombosis and Bleeding Academic Research Consortium (BARC) grade ≥3 bleeding. Patients were followed for 30 days. Results A total of 1,082 patients were enrolled. Adherence to consensus recommendations occurred in 85% of the cases. Perioperative aspirin and dual antiplatelet therapy were maintained in 69.7 and 10.5% of the cases, respectively. In-hospital NACE rate was 12.7%, being significantly higher in patients undergoing cardiac surgery (36.3% vs. 7.3%, P

The number of percutaneous coronary interventions (PCI) is increasing worldwide. Follow-up strategies after PCI are extremely heterogeneous and can greatly affect the cost of medical care. Of note, clinical evaluations and non-invasive exams are often performed to low risk patients. In the present consensus document, practical advises are provided with respect to a tailored follow-up strategy on the basis of patients' risk profile. Three strategies follow-up have been defined and types and timing of clinical and instrumental evaluations are reported. Clinical and interventional cardiologists, cardiac rehabilitators, and general practitioners, who are in charge to manage post-PCI patients, equally contributed to the creation of the present document.

Objectives To characterize the treatment of complex bifurcation lesions (BL) with the Tryton Bifurcation Stent (TBS) paired with an everolimus-eluting stent (EES). Background Complex BL are associated with higher procedural complications and poorer long-term outcomes. The TBS is a dedicated side-branch (SB) stent designed to be used in conjunction with a standard drug-eluting stent. Methods Prospectively identified, consecutive patients underwent TBS+EES stenting of BL using a protocol which included TBS postdilation and simultaneous final kissing balloon inflations (FKBI). All lesions were systematically evaluated with coronary angiography and IVUS, obtained at procedure completion and at 9 months, and were assessed by independent core laboratories. Results Thirty-three BL were treated in 32 patients presenting primarily (87.5%) with stable angina and complex BL with angiographic apparent disease in the main vessel (MV) and SB in 87.9% and 75% by site and core evaluation, respectively. Procedural success was 100% and high postprocedure percent stent expansion (MV 96 [93, 109]%, SB 88 [77, 100]%, carina MV 135 [99, 166]%, carina SB 116 [91, 130]%) was demonstrated by IVUS. At 9-month angiographic follow-up (n = 28 patients), one MV in-segment restenosis and one SB in-stent restenosis were observed. SB in-stent late lumen loss was 0.41 ± 0.27 mm. IVUS assessment revealed the absence of stent recoil; percent carinal neointimal hyperplasia (NIH) was 1.8 [0.0,11.2]% in MV and 15.0 [6.7,23.5]% in SB, with NIH volume obstruction of 2.0 [0.7,4.3]% in MV and 14.2 [7.5,29.6]% in SB. Conclusions Stenting of complex BL with the TBS+EES provides high acute success with sustained clinical, angiographic, and IVUS results at 9 months. These excellent results are likely due to the extent of stent expansion at the carina. © 2014 Wiley Periodicals, Inc.

Objectives: To evaluate stent thrombosis (ST) rate after sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) implantation in daily clinical practice. Background: The safety profile of drug-eluting stents (DES) was predominantly determined in randomized clinical trials with narrow inclusion criteria. Concerns about ST have been raised in unselected patients treated with DES. Methods: We prospectively evaluated 867 patients undergoing DES implantation, 618 patients with SES, and 249 with PES, in a single academic center. Results: Multivessel disease was present in 72% of patients, multivessel stenting was performed in 17%, long (>18 mm) lesions were treated in 30%, and multiple stents per lesion were needed in 31%. On average, 1.7 ± 0.8 stents per patient were implanted (stented segment length: 32 ± 25 mm/vessel). IIb/IIIa inhibitors were used in 7.5%. Intravascular ultrasound (IVUS) guidance was employed in 65% of SES and 50% of PES implantations, and the procedural success rate was 100% in SES and 99% in PES cases. Six-month follow-up was performed in all patients, whereas one-year follow-up was completed in 87% patients of the SES group and in 95% of the PES group. We considered that ST occurred when angiographic evidence of thrombus was available, or when patients experienced sudden cardiac death or either ST-elevation or non-ST-elevation myocardial infarction (MI) through the 12-month follow-up period. The overall incidence of ST was 0.9% (0.4% in SES and 2% in PES, P = 0.03). Of the eight ST, two (25%) were acute, four (50%) subacute, one (12.5%) was a late event, and one (12.5%) a very late event. Seven ST were confirmed by angiography. No IVUS guidance was used in 4/8 (50%) ST patients, while antiplatelet therapy was prematurely discontinued in 3/8 (37.5%). Among ST patients, mortality and nonfatal MI rates were 25% and 37.5%, respectively. No ST was diagnosed between 6 and 12 months, while one very late thrombosis occurred at 15 months. Conclusions: The incidence of ST after DES use in daily clinical practice is low and similar to that observed in randomized clinical trials. © 2007 Wiley-Liss, Inc.

Central venous catheters are routinely positioned for hemodynamic monitoring and fluid administration in patients undergoing cardiac surgery, and many well-known complications associated with this manoeuver have been described. Metalic guide wire embolization is a rare complication potentially associated with nonmechanical and mechanical adverse events. The case we report is peculiar as an almost fully endothelialized guide wire was successfully retrieved 9 months after its unintentional embolization in the inferior vena cava.

Worse outcomes have been observed in women after PTCA. The present study was undertaken to compare clinical and angiographic results of coronary stenting among women and men. We retrospectively analyzed acute and 6-month results in a consecutive series of 940 men and 160 women undergoing coronary stent implantation between May 1992 and January 1998. Women were older (63 vs. 57 years; P = 0.001), more often hypertensive (46.9% vs. 31.4%; P < 0.001) and diabetic (13.2% vs. 8.3%; P = 0.05), and less often smokers than men (32.5% vs. 70.5%; P < 0.001). A previous history of Q-wave MI was less frequently present in women (28.2% vs. 40.2%; P = 0.003) who more often underwent coronary revascularization because of unstable angina (37.5% vs. 27.1%; P = 0.027). No difference was observed in coronary artery disease extension, lesion complexity, and stented vessel between the sexes. Bailout stenting was more frequently needed in women (28% vs. 17.8%; P = 0.001). No difference was observed in the number of stent implanted per vessel and per patient and average maximal inflation pressure used for stent postdilation. However, a smaller final balloon size was used in women. Procedural and clinical success was achieved in 94.4% and 92.5% of women and 96.7% and 94.5% of men (P = NS), respectively, without differences regarding in-hospital major adverse cardiac events. Bleeding complications occurred more often in women when anticoagulation was used (OR = 2.87; 95% CI = 1.38–5.74). At 6-month clinical follow-up, TLR was similar between the sexes and event-free survival was 75.5% in women and 81.5% in men (P = NS). Angiographic follow-up, performed in 71% of the patients, showed that restenosis was 64% higher in women (OR = 1.64; 95% CI = 1.02–2.61). Despite older age, higher incidence of comorbidities, and more unstable presentation, women treated with coronary stenting showed acute and mid-term clinical results similar to those observed in men. However, they were significantly more likely to develop angiographic restenosis. Cathet Cardiovasc Intervent 2003;58:20–28. © 2003 Wiley-Liss, Inc.

We investigated by intravascular ultrasound (IVUS) the mechanism of action of cutting balloon (CB) angioplasty in patients with in-stent restenosis. Seventy-one consecutive restenotic lesions of 66 patients were studied by quantitative coronary angiography (QCA) and IVUS before, immediately after, and, in 20 cases, at 24-hr time interval after CB. CB was selected according to 1:1 CB-to-stent ratio and inflated at 8 atm for 60-90 sec. Both IVUS planar and volumetric (Simpson's rule, 25 patients) analysis were carried out. IVUS measurements included external elastic membrane area (EEMA), stent area (SA), minimal lumen area (MLA), and restenosis area (RA). Following CB, QCA analysis showed increase of minimal lumen diameter (1.17 +/- 0.46 vs. 2.45 +/- 0.51 mm; P < 0.0001) and decrease of diameter stenosis (64% +/- 13% vs. 21% +/- 9%; P < 0.0001). IVUS measurements showed a significant increase of MLA (2.18 +/- 0.80 vs. 7.31 +/- 1.8 mm(2); P < 0.0001), SA (9.62 +/- 2.6 vs. 10.7 +/- 2.75 mm(2); P < 0.0001), and EEMA (17.27 +/- 5 vs. 18.1 +/- 5 mm(2); P < 0.0001) and a decrease of RA (7.43 +/- 2.63 vs. 3.45 +/- 1.39 mm(2); P < 0.0001). No significant change was observed in the original plaque + media area (7.65 +/- 3 vs. 7.38 +/- 2.9 mm(2); P = NS). Thus, of the total lumen enlargement (5.13 +/- 1.85 mm(2)), 23% was the result of increase in mean SA, whereas 77% was the result of a decrease in mean RA. These changes were associated with a 5% increase in EEMA. IVUS volumetric changes paralleled planar variations. Angiographic and IVUS changes were well maintained at 24 hr. CB enlarges coronary lumen mainly by in-stent tissue reduction associated with a moderate degree of additional stent expansion. Favorable QCA and IVUS acute results are maintained at 24 hr.

The effect of stent coatings in preventing early thrombotic occlusion remains to be proved. The purpose of this study was to evaluate the safety and efficacy of the Carbostent™, a new coronary stent with a nonthrombogenic coating (Carbofilm™), in 110 consecutive patients (73.6% men, mean age 61 ± 9 years) who met prespecified clinical and angiographic inclusion criteria and were treated with aspirin monotherapy after stenting. Stable angina (75.5%), unstable angina (18.2%), and silent ischemia (6.3%) were clinical indications for coronary revascularization. Patients received 10,000 U of heparin and no IIb/IIIa inhibitors or postprocedural heparin. Complex lesion characteristics (B2, C) were present in 39 out of 129 (30.2%) lesions. Mean lesion length was 15.6 ± 7.4 mm, and 32% of the lesions were >15 mm (range 16–52 mm). Small coronary vessels (

Coronary stent implantation had been established as a highly effective revascularization technique in patients with occlusive coronary artery disease. Transcatheter closure of atrial septal defects is becoming a definite alternative to surgery in properly selected patients. During a 19-month period, 6 patients (50% women; mean age, 58 ± 17 years; range, 32–73 years) of a consecutive series of 176 prospective multicenter registry patients undergoing transcatheter atrial septal defect closure were treated with sequential percutaneous coronary revascularization and Amplatzer septal occluder implantation. Indication for revascularization was stable angina in four patients and unstable angina in two. Indication for defect closure was significant left-to-right shunt with right ventricular enlargement. Defect diameter ranged from 13 to 20 mm by transesophageal echocardiography, and the stretched diameter measured 13 to 25 mm. Procedural success of both interventions was achieved in all cases without in-hospital complications. A total of seven stents were successfully implanted in five coronary vessels. No stent was used in one patient after successful PTCA. Immediate total closure of the defect was obtained in five patients. Trivial residual shunting, observed in one patient, disappeared at 24 hr. No adverse cardiac events, recurrence of anginal symptoms, or evidence of residual shunt were observed at clinical and echocardiographic follow-up, which ranged from 60 to 390 days (mean, 258 ± 150 days). These results suggest that sequential transcatheter therapy of coronary artery disease and atrial septal defect is safe and efficacious in selected patients. Cathet Cardiovasc Intervent 2001;54:454–458. © 2001 Wiley-Liss, Inc.

We describe a new diagnostic catheter specifically designed for selective catheterization of the left internal mammary artery via the ipsilateral radial approach. We used this catheter to assess the patency of the distal mammary-left anterior descending coronary artery anastomosis in 30 consecutive patients early after minimally invasive direct coronary artery bypass grafting. The new catheter design allowed easy and fast engagement of the left internal mammary artery leading to optimal vessel opacification in all cases. Angiography revealed graft problems in seven (23.3%) patients, two of whom required anastomosis revision, surgical in one case and with PTCA in the other. No LIMA injury occurred as a result of selective catheterization. Patients with functionally normal anastomosis were discharged on the same day of the diagnostic procedure.

Despite improvements in coronary stent design, delivery difficulties may still be encountered. Between April 1996 and September 1998, 945 patients underwent coronary stenting in our Institute. New 6 Fr Long Brite Tip (LBT) guiding catheters, allowing deep coronary artery intubation and increased backup support, were used in 25 (2.6%) of these patients presenting complex coronary anatomy and poor stent accessibility, electively in 3 (12%) and after stent delivery failure with multiple (2.1 +/- 1.2) standard guiding catheters in 22 (88%). Deep coronary artery intubation (>/= 20 mm) was successfully performed in 22 (88%) patients and was associated with adequate pressure recording and contrast opacification without blood flow compromise. Ten (22.7%) Palmaz-Schatz stents and 34 (77.3%) second-generation stents of various lengths were successfully delivered to different coronary vessels (RCA = 15, LAD = 9, LCx = 1) in all patients in whom deep coronary intubation was obtained. These data demonstrate that deep coronary artery cannulation with LBT catheters is feasible and safe and may markedly increase the rate of stent delivery success in very complex coronary anatomy and when standard guiding catheters have failed.