Intermediate Clinical and Hemodynamic Outcomes After Transcatheter Aortic Valve Implantation.

BACKGROUND: Concerns still exist regarding long-term results and freedom from valve-related adverse events in transcatheter aortic valve implantation (TAVI). The aim of this single-center retrospective study was to assess intermediate-term (up to 5-year) clinical and hemodynamic outcomes in patients undergoing TAVI. METHODS: From 2007 through 2013, 338 consecutive patients underwent TAVI at our institution. Preoperative variables were defined according to the European System for Cardiac Operative Risk Evaluation (EuroSCORE) definitions, and outcomes were reported according to the Valve Academic Research Consortium (VARC)-2 definitions. Multivariate logistic regression analysis was performed to identify independent predictors of mortality at follow-up. RESULTS: transfemoral (TF) and transapical (TA) TAVI were performed in 233 (69%) and 105 (31%) patients, respectively. All-cause 30-day mortality was 4.4%, with no differences between TA and TF procedures. Thirty-day cardiovascular death, stroke, and myocardial infarction were not different between groups. The acute kidney injury (AKI) rate was higher in the TA group (30.5% versus 11.2%; p < 0.001). Access-related complications were more frequent in the TF group (36.1% versus 11.4%; p < 0.001). Mean follow-up was 22.3 ± 17.8 months (range, 1-74 months). Overall survival rates at 1, 3, and 5 years were 85.5% ± 2.1%, 69.9% ± 3.2%, and 61% ± 4.3%, respectively. Independent predictors of all-cause mortality at follow-up were previous myocardial infarction (odds ratio [OR], 2.7), any grade of paravalvular leak (PVL) (OR, 2.5), and AKI (OR, 3.1). Mean gradient and effective orifice area at follow-up were 10.7 ± 12.0 mm Hg and 1.1 ± 0.9 cm(2)/m(2), respectively. CONCLUSIONS: Our data show that TAVI has good early and intermediate-term clinical and hemodynamic outcomes in high-risk or inoperable patients with severe symptomatic aortic valve stenosis. PVL of any grade has a significant impact on survival.

Left atrial appendage closure: beyond the artifact.

: Transesophageal echocardiography (TEE) represents the gold standard technique to detect left atrial appendage (LAA) thrombosis. Several conditions may be erroneously interpreted as LAA thrombus at TEE, including artifacts mimicking thrombi. We report a case of a 78-year-old man with atrial fibrillation and contraindication to anticoagulation who was referred to our institution for percutaneous left appendage closure with a transcatheter trans-septal approach. Intraoperative transesophageal echocardiography revealed a thrombus-mimicking image, related to reverberations of left upper pulmonary vein ridge, located at twice the distance of the ridge from the transducer.

Right-to-left interatrial shunt secondary to right hemidiaphragmatic paralysis: an unusual scenario for urgent percutaneous closure of patent foramen ovale.

A 66 year-old female presented with a refractory hypoxaemia in association with an isolated paralysis of the right hemidiaphragm. Transoesophageal echocardiography (TEE) with both colour Doppler and bubble test demonstrated a significant patent foramen ovale (PFO)-mediated right-to-left shunt (RTLS) without an increased interatrial pressure gradient. The PFO was urgently closed by deployment of an AMPLATZER(®) occluder device, resulting in complete recovery of the arterial oxygen saturation and patient's symptoms. As noted on TEE, the RTLS was due to redirection of blood flow from the inferior vena cava directly through the PFO secondary to distortion of the cardiac anatomy by right hemidiaphragmatic paralysis.

Thrombus burden and myocardial damage during primary percutaneous coronary intervention.

Large thrombus burden (LTB) lesions in the context of primary percutaneous coronary intervention (p-PCI) have been related to unsuccessful angiographic reperfusion and unfavorable clinical outcomes. However, the hazard of LTB treatment on myocardial damage has not been evaluated. We investigated the impact of LTB on myocardial damage using contrast-enhanced cardiac magnetic resonance (CE-CMR) in the setting of p-PCI. In 327 patients, who underwent p-PCI without thrombus aspiration within 12 hours from symptom onset, we prospectively assessed the impact of LTB on infarct size and microvascular damage using CE-CMR. LTB was defined by the presence of Thrombolysis In Myocardial Infarction thrombus score ≥3 in patent infarct-related artery (IRA); or by "cut-off" occlusion pattern and/or large reference vessel diameter (≥3.5 mm) in occluded IRA. One hundred ninety-seven patients (60.2%) showed LTB and 130 (39.8%) did not. Distal embolization occurred in 18.8% patients with versus 6.9% without LTB (p = 0.003). At CE-CMR, patients with LTB had larger infarct size index (27.5 ± 11.1 vs 22.1 ± 17.5, p = 0.009) and more often transmural necrosis (70.5% vs 55.4%, p = 0.008) compared with patients without LTB. Excluding patients with distal embolization, patients with LTB still had larger necrosis. At multivariate analysis, occluded (IRA) at baseline, anterior infarction, and presence of LTB predicted transmural necrosis. In conclusion, LTB in the setting of p-PCI is related to larger myocardial damage as detected by CE-CMR, regardless of angiographic detectable distal embolization.

Clinical outcome of patients with de novo coronary bifurcation lesions treated with the Tryton Side Branch Stent. The SAFE-TRY prospective multicenter single arm study.

BACKGROUND: Coronary bifurcation lesions represent a difficult problem regularly confronting interventional cardiologist, in part due to the lack of dedicated device. OBJECTIVE: To investigate the feasibility, safety and effectiveness of the Tryton Side Branch Stent (Tryton Medical, Durham, NC, USA), a dedicated bare metal stent deployed in conjunction with a standard drug-eluting stent to treat bifurcation lesions. METHODS: The SAFE-TRY is a prospective single arm multicenter registry including patients with de novo bifurcation lesions in native coronary arteries and syntax score <32. The primary endpoint was target vessel failure (TVF) at 30 days that comprised cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization. Secondary endpoints included device, angiographic and procedural success, 9-month major adverse cardiac and cerebrovascular event (MACCE), and stent thrombosis (ST) rates (ClinicalTrials.gov identifier: NCT01174433). RESULTS: Among 252 enrolled patients, 24% had diabetes and 35.3% unstable angina. True bifurcation lesions involving both branches occurred in 96.8% of cases with Medina classification 1.1.1 in 62%. The left anterior descending artery and the left main were treated in 70% and 8.3% of the patients, respectively. A 6 Fr guide catheter was used in 61% of the cases. Device, angiographic and procedural success rates were 99.6%, 99.6% and 97.2% respectively. The 30-day TVF was 2.8%; the 9-month MACCE rate was 13.7%, with target lesion revascularization being 4.4%. No definite ST occurred. CONCLUSIONS: This prospective, multicenter study confirmed the feasibility, safety and effectiveness of the Tryton Side Branch Stent to treat patients with de novo complex bifurcation lesions.

Six-year clinical outcomes of first-generation drug-eluting stents: a propensity-matched analysis.

OBJECTIVE: Drug-eluting stents are more effective in reducing restenosis than bare-metal stents. Paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) are the most widely used first-generation drug-eluting stents, but long-term comparative data on these are scant. The aim of the present report is to investigate the 6-year clinical outcomes of PES versus SES in a matched cohort of single-center registry patients. MATERIALS AND METHODS: Data were obtained from the observational, monocentric registry of 632 consecutive patients who underwent percutaneous coronary intervention between September 2002 and September 2005 with PES or SES. We assessed the composite and separate occurrence of the major adverse cardiac events (MACE), including death, nonfatal myocardial infarction, and target lesion revascularization (TLR). RESULTS: After a propensity 1 : 1 matching analysis, baseline clinical, procedural, and angiographic characteristics were well balanced between the two groups. Throughout the 6 years of follow-up, there were no significant differences between PES and SES in terms of MACE (P=0.52), all-cause death (P=0.24), myocardial infarction (P=0.25), stent thrombosis (P=0.38), and TLR (P=0.68). The sensitivity analysis on the total unmatched population confirmed this result, the stent type not being predictive of MACE (PES vs. SES group, hazard ratio 0.97, 95% confidence interval 0.66-1.41, P=0.87) or TLR (PES vs. the SES group, hazard ratio 1.35, 95% confidence interval 0.69-2.64, P=0.38). CONCLUSION: In this 'real-life' registry, PES and SES showed a comparable safety and efficacy profile throughout the 6 years of follow-up. The increase in the rate of TLR was slow and comparable between the two groups, even though the 'late catch-up' phenomenon showed a different temporal pattern between PES and SES.

Comparison of variables in men versus women undergoing transcatheter aortic valve implantation for severe aortic stenosis (from Italian Multicenter CoreValve registry).

Although transcatheter aortic valve implantation (TAVI) for severe aortic stenosis is becoming an established technique, the effect of gender-related differences is poorly described. We performed a gender-based comparison of high-risk patients undergoing TAVI with the self-expandable CoreValve Revalving System for severe aortic stenosis to evaluate early and mid-term clinical outcomes. From the Italian prospective CoreValve registry, 659 consecutive patients (55.8% women) who underwent TAVI were included in the present study. We analyzed the gender-based differences in terms of clinical, angiographic, and procedural features and the differences in the rate of early and mid-term major adverse cardiac and cerebrovascular events. The men were younger, presented more often with severe left ventricular dysfunction, and had a greater rate of previous myocardial infarction, coronary revascularization, peripheral artery disease, renal failure, and heart conduction disorders than the women. The logistic European System for Cardiac Operative Risk Evaluation score did not differ between the 2 groups. The overall unadjusted and adjusted analyses failed to show significant differences between genders in terms of major adverse cardiac and cerebrovascular events at a median follow-up of 13 months (range 8 to 18). At late follow-up (landmark analysis >12 months), a survival benefit was observed in women (hazard ratio 0.27, 95% confidence interval 0.09 to 0.84, p = 0.02). In conclusion, in this multicenter registry, the gender-based comparison of TAVI patients showed that men, despite the younger age, had more extensive atherosclerotic burden compared to women. Overall, the early and mid-term outcomes were similar between genders, although women might have a survival benefit with longer follow-up.

Safety and effectiveness of a selective strategy for coronary artery revascularization before transcatheter aortic valve implantation.

OBJECTIVES: We assessed the safety and effectiveness of a selective percutaneous revascularization strategy before TAVI in a single-center prospective registry. BACKGROUND: Management of Coronary Artery Disease (CAD) before Transcatheter Aortic Valve Implantation (TAVI) is not yet established. METHODS: Percutaneous Coronary Intervention (PCI) was scheduled in proximal-to-mid coronary segment lesions on major coronary branches. TAVI was performed by percutaneous trans-femoral, trans-subclavian or trans-apical approach, using either the self-expandable III generation CoreValve (Medtronic, Minneapolis, Minnesota USA) or the Edwards SAPIEN(™) /SAPIEN XT balloon-expandable prosthesis (Edwards Lifesciences Irvine, CA). Clinical and echocardiographic follow-up was collected at 30-day, 3,6,12-month and yearly thereafter. RESULTS: Out of 191 patients who underwent TAVI, 113 (59.2%) had CAD. Mean age was 80.5 ± 6.9 years (57.6% female), logistic EuroSCORE was 21.4% ± 13.4. Twenty-seven (14.1%) patients had previous percutaneous and 29 (15.2%) surgical revascularization. PCI was performed as scheduled before TAVI in 39 (20.4%) patients, without adverse events. Complete anatomical revascularization was obtained in 38 of 113 CAD patients (33.6%). After TAVI, 30-day mortality was 4.2%, and was comparable between CAD and no-CAD patients (P = ns), while 30-day myocardial infarction incidence was 2.6% and occurred only in the CAD group (4.4%, P = 0.06). Overall mortality at follow-up (12.9 ± 9.5 months) was 14.8%, without difference between groups (P = 0.88). At follow-up, five patients underwent coronary revascularization. CONCLUSIONS: In this study, the incidence of CAD is high in patients referred for TAVI. A selective, clinical based, coronary revascularization before TAVI seemed to be safe, and was associated with an outcome similar to those observed in no-CAD TAVI patients.

Paclitaxel- and sirolimus-eluting stents in older patients with diabetes mellitus: results of a real-life multicenter registry.

BACKGROUND: Older patients and diabetes mellitus (DM) are rapidly increasing in Western world populations. The treatment of coronary artery disease in these patients is challenging because they are complex and at high risk. Performance of the two widely used drug-eluting stents (DES), i.e. sirolimus- (SES) and paclitaxel-eluting stent (PES), is understudied in this subset. AIM: We aimed to explore the impact of the first generation DES choice on mid term outcome in a large and unselected population of diabetic patients older than 65 years. METHODS AND RESULTS: From a multicenter registry of 2,429 diabetic patients treated with sirolimus- (SES) or paclitaxel-eluting stent (PES), 1,417 patients ≥65 years old were analyzed overall and separately for groups aged 65-74 (67%) and ≥75 (33%) years old. SES (55%) were compared to PES (45%) in terms of major adverse cardiac events, including all-cause death, myocardial infarction (MI) and target lesion revascularization (TLR) throughout 1-to-5 year follow-up (median time 24 months). We failed to find at the unadjusted and adjusted analyses statistically significant differences in term of outcome between the two DES, both in the overall cohort and in the two different aged subgroups, also regardless of the insulin treatment. CONCLUSIONS: In this real-life multicenter registry, PES and SES showed a comparable safety and efficacy profile in diabetic patients older than 65 years throughout 1-to-5 years follow-up.

Gender-related differences of diabetic patients undergoing percutaneous coronary intervention with drug-eluting stents: a real-life multicenter experience.

BACKGROUND: Gender-based differences in diabetic patients are understudied in the field of percutaneous coronary intervention (PCI) with drug-eluting stents. METHODS: Data were obtained from a multicenter registry of 2420 consecutive patients with diabetes mellitus (DM) who underwent PCI with paclitaxel- or sirolimus-eluting stents between 2003 and 2009. Among them, 679 (28.1%) women were compared to 1741 (71.9%) men in terms of clinical aspects and major adverse cardiac events (MACE), including all-cause death, myocardial infarction (MI) and target lesion revascularization (TLR). Target vessel revascularization (TVR) and any revascularization were also reported. RESULTS: Women were less numerous, older, used more insulin and showed more tortuous coronary arteries, while men were more frequently smokers and received larger stents. At the median follow-up of 24.3 months (interquartile range 12.3-39.7), MACE, TVR and any revascularization did not significantly differ between females and males (19.9% vs 18.7%, 12.2% vs 13.4%, 14.1% vs 15.1%, respectively). At multivariable analysis of the overall cohort, female gender was not a predictor of MACE (hazard ratio [HR] 1.02, 95% confidence interval [CI] 0.92-2.36, p=0.11), death (HR 1.04, 95% CI 0.84-1.24, p=0.86), MI (HR 1.48, 95% CI 0.92-2.36, p=0.11), and TLR (HR 1.14, 95% CI 0.85-1.52, p=0.38). CONCLUSION: In this registry of diabetic patients treated by drug-eluting stents, women were less represented, older and needed more insulin compared to men who, on the other hand, received larger stents. Gender-related outcomes were similar and female sex did not predict MACE.

Time-dependent detrimental effects of distal embolization on myocardium and microvasculature during primary percutaneous coronary intervention.

OBJECTIVES: The authors sought to investigate the impact of distal embolization (DE) on myocardial damage and microvascular reperfusion, according to time-to-treatment, using contrast-enhanced cardiac magnetic resonance (CE-CMR). BACKGROUND: DE, occurring during primary percutaneous coronary intervention (p-PCI), appears to increase myocardial necrosis and to worsen microvascular perfusion, as shown by surrogate markers. However, data regarding the behavior of DE on jeopardized myocardium, and in particular on necrosis extent and distribution, are still lacking. METHODS: In 288 patients who underwent p-PCI within 6 h from symptom onset, the authors prospectively assessed the impact of DE on infarct size and microvascular damage, using CE-CMR. The impact of DE was assessed according to time-to-treatment: for group 1, <3 h; for group 2, ≥3 and ≤6 h. RESULTS: DE occurred in 41 (14.3%) patients. Baseline clinical characteristics were not different between the 2 groups. At CE-CMR, patients with DE showed larger infarct size (p = 0.038) and more often transmural necrosis compared with patients without DE (p = 0.008) when time-to-treatment was <3 h, but no impact was proven after this time (p = NS). Patients with DE showed more often microvascular obstruction, as evaluated at first-pass enhancement, than patients without DE (100% vs. 66.5%, p = 0.001) up to 6 h from symptom onset. CONCLUSIONS: These findings suggest that the detrimental impact of DE occurring during p-PCI on myocardial damage is largely influenced by ischemic time, increasing the extent of necrosis in patients presenting within the first hours after symptom onset, and having limited or no impact after this time window.

Comparison between sirolimus- and paclitaxel-eluting stents for the treatment of older patients affected by coronary artery disease: results from a single-center allcomers registry.

The treatment of elderly patients with coronary artery disease (CAD) is challenging because this population is complex and greatly expanding. Drug-eluting stents (DES) generally improve the outcome in high-risk cases. We evaluated the clinical impact of different first-generation DES, i.e., sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), in this context. A prospective, nonrandomized, single-center, allcomers registry consecutively enrolling all patients aged ≥75 years eligible for percutaneous coronary intervention (PCI) with DES was carried out. Only one type of DES was implanted per protocol for each patient. Two groups were identified according to the type of implanted stent, i.e., SES and PES. The primary end point encompassed major adverse cardiac events (MACE), including death, myocardial infarction, and target lesion revascularization (TLR). The secondary end point encompassed the rate of definite/probable stent thrombosis and target vessel revascularization (TVR). From June 2004 to May 2008, 151 patients were enrolled. Among them, 112 (74.2%) received SES and 39 (25.8%) received PES. Baseline clinical characteristics were similar, while few angiographic features (ostial location, stent diameter, proximal reference vessel diameter) showed minor differences. At the median follow-up of 22.6 months, primary and secondary end points did not significantly differ in terms of MACE (SES 12.5% vs PES 20.5%, P = 0.3), death (SES 5.4% vs PES 7.7%, P = 0.7), myocardial infarction (SES 4.5% vs PES 10.3%, P = 0.2), TLR (SES 2.7% vs PES 2.6%, P = 1.0), stent thrombosis (SES 1.8% vs PES 5.1%, P = 0.3), and TVR (SES 1.8% vs PES 0%, P = 0.6). In this real-world population of elderly patients treated by DES-PCI for CAD, the overall efficacy and safety have been excellent in both DES, and the choice between SES and PES did not influence the clinical outcome.

Left ventricular apical ballooning syndrome in men: a case series.

OBJECTIVES: Apical ballooning syndrome usually involves elderly women. We reported the profile of this syndrome in men. METHODS: We identified 54 consecutive patients with the syndrome: among them, seven were men (13%, group M) and 47 were women (87%, group F). RESULTS: Men were younger than women (group M 61.7 years vs. group F 72.8 years, median age, P < 0.01) and emotional triggers predominated in women ( group M 14.3% vs. group F 44.7%, P = 0.01) compared with physiological ones which were more frequent in men (group M 42.9% vs. group F 19.1%, P = 0.02). At onset, men were more compromised than women (group M 42.9% vs. group F 6.4%, P = 0.004). At the median follow-up of 18.5 months, more men died than women (group M 28.6% vs. group F 8.5%, P = NS), but only women had cardiac-related deaths (group M 0% vs. group F 6.4%, P = NS). Cardiac outcome was similar in both groups (group M 14.3% vs. group F 23.4%, P = NS). Left ventricular ejection fraction increased in both sexes from 41% to more than 56% (P < 0.01). CONCLUSION: In this small case series, left ventricular apical ballooning syndrome showed similar features in both sexes. However, men seemed to be more affected at younger age, presented more physiological triggers and more compromised clinical status at admission. Despite this, cardiac outcome was good in both sexes.