Transapical Deployment of Thoracic Stent Graft for Ascending Aorta Coronary Bypass Pseudoaneurysm in a Patient with Prosthetic Aortic Valve.

The authors describe the transapical deployment of a thoracic endograft to exclude a saphenous vein graft proximal anastomotic pseudoaneurysm following coronary artery bypass grafting (CABG) in a 63-year-old male with a prosthetic aortic valve. A standard thoracic endograft has been deployed via transapical access after percutaneous transluminal coronary angioplasty of the native vessel perfused by the patent CABG. The procedure was uneventful; an 8-month computed tomography scan showed complete exclusion of the pseudoaneurysm with patency of supra-aortic trunks.

Depressive symptoms, functional measures and long-term outcomes of high-risk ST-elevated myocardial infarction patients treated by primary angioplasty.

The presence of major depressive symptoms is usually considered a negative long-term prognostic factor after an acute myocardial infarction (AMI); however, most of the supporting research was conducted before the era of immediate reperfusion by percutaneous coronary intervention. The aims of this study are to evaluate if depression still retains long-term prognostic significance in our era of immediate coronary reperfusion, and to study possible correlations with clinical parameters of physical performance. In 184 patients with recent ST-elevated AMI (STEMI), treated by immediate reperfusion, moderate or severe depressive symptoms (evaluated by Beck Depression Inventory version I) were present in 10 % of cases. Physical performance was evaluated by two 6-min walk tests and by a symptom-limited cardiopulmonary exercise test: somatic/affective (but not cognitive/affective) symptoms of depression and perceived quality of life (evaluated by the EuroQoL questionnaire) are worse in patients with lower levels of physical performance. Follow-up was performed after a median of 29 months by means of telephone interviews; 32 major adverse cardiovascular events (MACE) occurred. The presence of three vessels disease and low left ventricle ejection fraction are correlated with a greater incidence of MACE; only somatic/affective (but not cognitive/affective) symptoms of depression correlate with long-term outcomes. In patients with recent STEMI treated by immediate reperfusion, somatic/affective but not cognitive/affective symptoms of depression show prognostic value on long-term MACE. Depression symptoms are not predictors "per se" of adverse prognosis, but seem to express an underlying worse cardiac efficiency, clinically reflected by poorer physical performance.

Functional parameters but not heart rate variability correlate with long-term outcomes in St-elevation myocardial infarction patients treated by primary angioplasty.

BACKGROUND: Depressed heart rate variability (HRV) is usually considered a negative long-term prognostic factor after acute myocardial infarction. Anyway, most of the supporting research was conducted before the era of immediate reperfusion by percutaneous coronary intervention (PCI). Main aim of this study was to evaluate if HRV still retains prognostic significance in our era of immediate PCI. METHODS AND RESULTS: Two weeks after STEMI treated by primary PCI, time-domain HRV was assessed from 24-h Holter recordings in 186 patients: markedly depressed HRV (SDNN <70ms or <50ms) was present in 16% and in 5% of cases, respectively; patients with left ventricle ejection fraction (LVEF) <40% presented more often SDNN values in the lowest quartile. Physical performance was also assessed, by 6-minute walk tests (6MWT) and by cardiopulmonary exercise test (CPET). After >2years from infarction, occurrence of major clinical events (MCE) was investigated. Cases with or without MCE did not differ by initial HRV parameters; Kaplan-Meier events-free survival curves were similar between patients with lowest quartile SDNN and the remaining ones (χ2 0.981, p=0.322). By the contrary, events-free survival was worse if patients walked shorter distances at 6MWT (χ2 6.435, p=0.011), developed poorer ventilatory efficiency at CPET (χ2 10.060, p=0.002), or presented LVEF <40% (χ2 7.085, p=0.008). CONCLUSIONS: In primary-PCI STEMI patients, markedly abnormal HRV was found in a small percentage of cases. HRV seems to have lost its prognostic significance, while parameters indicating LV function (LVEF and physical performance) could allow better prognostication in primary-PCI STEMI patients.

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.

Impact of type of intervention for aortic valve replacement on heart rate variability.

BACKGROUND: It is known that coronary heart surgery leads to varying degrees of cardiac autonomic derangement, clinically detectable as depression of heart rate variability (HRV) parameters. Few studies report that also surgical replacement of the aortic valve (SAVR) may lead to HRV abnormalities, while very little is known about the autonomic effects obtained after less invasive aortic valve replacement techniques. The study aimed to evaluate HRV after SAVR and to compare it with two less invasive techniques, transapical (TaAVI) and tranfemoral (TfAVI) aortic valve implant. METHODS: Time-domain heart rate variability (HRV) parameters have been studied by 24-h Holter ECG in 129 patients after SAVR, in 63 patients after TfAVI and in 19 patients after TaAVI. RESULTS: All HRV parameters were significantly depressed in SAVR, while they were almost completely preserved in TfAVI patients; TaAVI cases showed a somehow intermediate behaviour [(SDNN respectively: 71.0±34.9 vs 95.9±29.5 (p<0.001) vs 84.4±32.6ms (p=ns)]. Mean heart rate during the 24-h Holter was 8% higher in SAVR patients than in both TfAVI and TaAVI patients. The reported results were not correlated with echocardiographic ejection fraction, or presence of abnormal glucose metabolism, or degree of anaemia or treatment with beta-blockers. CONCLUSIONS: SAVR leads to profound depression of some cardiac autonomic parameters, while less invasive procedures allow better preservation of HRV. In particular TfAVI does not induce any significant deterioration of HRV parameters and seems to be the strategy of valve implant with less impact on the cardiovascular autonomic system.

Unravelling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve.

AIMS: Early data on the Edwards SAPIEN 3 valve (S3-THV) have shown low rates of paravalvular leaks and vascular complications but relatively high 30-day permanent pacemaker implantation (PPMI) rates. No direct comparisons on clinical outcomes including PPMI rates are available for the S3-THV and the Edwards SAPIEN XT (XT-THV). We aimed to compare the 30-day PPMI rates in patients treated with the two prostheses and to assess the interplay among valve type, depth of implantation and PPMI rate. METHODS AND RESULTS: Two hundred and nine patients treated by TAVI were considered. The S3-THV was associated with higher PPMI rates compared to the XT-THV, both overall and in subgroups matched for several predictors of PPMI. However, in the S3-THV group, 30-day PPMI was strictly associated with deep valve implantation, and PPMI risk of high-implanted S3-THVs was similar to that of the overall XT-THV matched group. No cases of significant paravalvular leak were observed in the S3-THV group. CONCLUSIONS: The S3-THV was associated with a higher incidence of PPMI compared to the XT-THV. In the S3-THV group, pacemaker implantation was strictly associated with deep valve implantation. An implantation technique involving higher initial placement of the central marker (from 0 to 3 mm above the base of the aortic cusps) and, as a consequence, higher final valve depth might help in preventing post-TAVI PPMI with the S3-THV, without affecting the risk of paravalvular leak.

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.

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.

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.

Transcatheter aortic valve implantation in patients with severe left ventricular dysfunction: immediate and mid-term results, a multicenter study.

BACKGROUND: Few data exist about transcatheter aortic valve implantation (TAVI) in patients with low ejection fraction. The aim of the study was to analyze safety, feasibility, and efficacy of TAVI in patients with severe left ventricular dysfunction. METHODS AND RESULTS: The study sample (384 patients) was divided into 2 groups: group A (50 patients) with left ventricular ejection fraction (LVEF) ≤35%, and group B (334 patients) with LVEF >35%. Clinical, anatomic, and hemodynamic variables, as well as procedural results and follow-up outcomes, were compared between the groups. Procedural success was reached in 88%, with no significant difference between the groups. The incidence of periprosthetic leak >2+/4 after TAVI was higher in group A. All other complications were similar between the 2 groups. Group A showed a significant and early improvement in LVEF (from 27.7±6.0-35.2±11.1 after TAVI; P<0.0001). Thirty-day mortality was 4%; however, this was higher in group A compared with group B (10% versus 3%; P=0.010). Predictors of the cumulative late mortality were congestive heart failure, logistic euroSCORE, and moderate-to-severe periprosthetic leakage after TAVI. Estimated survival by Kaplan Meier at 1 year was, respectively, 69% in group A and 87% in group B (log rank <0.0001). CONCLUSIONS: Transcatheter aortic valve implantation is a safe and effective procedure, even in patients with severe left ventricular dysfunction, leading to a high procedural success rate with an acceptable rate of complications and 30-day mortality. Also in these critically ill patients, TAVI provides clinical amelioration, with early improvement in LVEF.

Postconditioning during coronary angioplasty in acute myocardial infarction: the POST-AMI trial.

BACKGROUND: Postconditioning (PC) has been suggested to reduce myocardial damage during primary percutaneous coronary intervention (PPCI), nevertheless clinical experience is limited. We aimed to explore the cardioprotective effect of PC using cardiac magnetic resonance (CMR) in ST-elevation myocardial infarction (STEMI) patients treated by PPCI. METHODS: A total of 78 patients with first STEMI (aged 59±12 years) referred for PPCI, were stratified for STEMI location and randomly assigned to conventional PPCI or PPCI with PC. All patients, with occluded infarct related artery and no collateral circulation, received abciximab intravenously before PPCI. After reperfusion by effective direct stenting, control subjects underwent no further intervention, while in treated patients PC was performed within 1 min of reflow by 4 cycles of 1-minute inflation and 1-minute deflation of the angioplasty balloon. Primary end-point was infarct size (IS) reduction, expressed as percentage of left ventricle mass assessed by delayed enhancement on CMR at 30±10 days after index PPCI. RESULTS: All baseline characteristics but diabetes (p=0.06) were balanced between groups. Postconditioning patients trended toward a larger IS compared to those treated by standard PPCI (20±12% vs 14±10%, p=0.054). After exclusion of diabetics, PC group still showed a trend to larger IS (p=0.116). Major adverse events seem to be more frequent in PC group irrespective to diabetic status (p=0.053 and p=0.080, respectively). CONCLUSIONS: This prospective, randomized trial suggests that PC did not have the expected cardioprotective effect and on the contrary it might harm STEMI patients treated by PPCI plus abciximab. (Clinical Trial Registration-unique identifier: NCT01004289).