Paolo Buja

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

We assessed the safety and effectiveness of a selective percutaneous revascularization strategy before TAVI in a single‐center prospective registry.

Diffuse, marked, reversible impairment in coronary microcirculation in stress cardiomyopathy: A Doppler transthoracic echo study

The aim of the study was to assess coronary flow reserve (CFR) in tako-tsubo cardiomyopathy (TC). Methods and results. Thirty consecutive patients (5 males; age 68±12 years) meeting diagnostic criteria for TC were evaluated with transthoracic dipyridamole (0.84 mg/kg over 6 min) stress echo and pulsed Doppler CFR assessment on mid-distal left anterior descending (LAD) and posterior descending of right coronary artery (PD). Wall motion score index (WMSI) was evaluated at base-line and during stress. All patients were followed up clinically and—on day 1, day 7 (±2 days), and at 6 months—by repeat stress echo. Thirty gender- matched controls were also studied. CFR was obtained in all patients on LAD and in 25 on PD. All showed a transient apical ballooning in the acute phase (day 1 of admission), with progressive recovery of function at follow-up (WMSI, day 1 = 1.7±0.2; day 7 = 1.4±0.14; 6 months = 1.0±0.1; P<0.001 versus day 1 and versus day 7). When compared to controls (3.1±0.5), CFR on LAD was reduced on day 1 (1.8±0.24, P<0.001) (upon admission), and it showed early recovery in the subacute (pre-discharge) assessment on day 7. CFR values remained stable at 6-month follow-up (2.6±0.3). Conclusion. TC is characterized by a profound, diffuse coronary microcirculatory disturbance in the acute phase, with early reversal to near-normal values within a few days, paralleling the functional recovery in regional wall motion.

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.

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.

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.

Long-term outcome and sex distribution across ages of left ventricular apical ballooning syndrome.

Objective Apical ballooning syndrome is a rare clinical entity that predominantly involves elderly women and is considered to be benign. We report our experience regarding this syndrome in terms of sex distribution and long-term outcome. Methods Between 1999 and 2006, we identified 28 consecutive patients affected by the apical ballooning syndrome. Inclusion criteria were an onset of mimicking acute myocardial infarction, transient akinesia/dyskinesia of the mid-apical left ventricular segments and no significant obstructive coronary artery disease. Patients with a recent brain disease, pheocromocytoma, hypertrophic cardiomyopathy and suspected myocarditis were excluded. Sex distribution was assessed across different ages according to quartiles: less than 61 years of age (group 1), 61–71 years (group 2), 72–77 years (group 3) and more than 77 years (group 4). In-hospital and follow-up events were observed. Results The apical ballooning syndrome represented 1.69% of ST-segment elevation acute coronary syndromes. There were more women than men in groups 2 (85.7 vs. 14.3%), 3 (85.7 vs. 14.3%) and 4 (100 vs. 0%), but there were fewer women than men in group 1 (42.9 vs. 57.1%), with an overall supremacy of women (78.6 vs. 21.4%) (P = 0.02). In-hospital events were one (3.6%) cardiac death and five (17.9%) nonfatal events. At the median follow-up of 24 months, one patient was lost and two (7.7%) died of cardiac causes, thus, the total cardiac mortality was 10.7% (3/28 patients); no recurrence occurred and left ventricular ejection fraction increased from 40.4 to 58.6% (P < 0.01). Conclusion In our population, left ventricular apical ballooning syndrome included several typical features. However, a peculiar sex tendency across various age groups was observed and, although older women predominated, men seemed to be more affected than women at a younger age. The long-term prognosis seems to be favourable.

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.

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.

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.

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

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.