Minimally invasive surgical versus transcatheter aortic valve replacement: A multicenter study.

OBJECTIVES: Treatment of aortic valve stenosis is evolving, indications for transcatheter approach (TAVI) have increased but also surgical valve replacement has changed with the use of minimally invasive approaches. Comparisons between TAVI and surgery have rarely been done with minimally invasive techniques (mini-SAVR) in the surgical arm. Aim of the present study is to compare mini-SAVR and TAVI in a multicenter recent cohort. METHODS: Evaluated were 2904 patients undergone mini-SAVR (2407) or TAVI (497) in 10 different centers in the period 2011-2016. The Heart Team approved treatment for complex cases. The primary outcome is the incidence of 30-day mortality following mini-SAVR and TAVI. Secondary outcomes are the occurrence of major complications following both procedures. Propensity matched comparisons was performed based on multivariable logistic regression model. RESULTS: In the overall population TAVI patients had increased surgical risk (median EuroSCORE II 3.3% vs. 1.7%, p ≤ 0.001) and 30-day mortality was higher (1.5% and 2.8% in mini-SAVR and TAVI respectively, p = 0.048). Propensity score identified 386 patients per group with similar baseline profile (median EuroSCORE II ~3.0%). There was no difference in 30-day mortality (3.4% in mini-SAVR and 2.3% in TAVI; p = 0.396) and stroke, surgical patients had more blood transfusion, kidney dysfunction and required longer ICU and hospital length of stay while TAVI patients had more permanent pace maker insertion. CONCLUSIONS: Mini-SAVR and TAVI are both safe and effective to treat aortic stenosis in elderly patients with comorbidities. A joint evaluation by the heart-team is essential to direct patients to the proper approach.

Impact of sex on comparative outcomes of bivalirudin versus unfractionated heparin in patients with acute coronary syndromes undergoing invasive management: a pre-specified analysis of the MATRIX trial.

AIMS: Our aim was to assess whether bivalirudin compared with unfractionated heparin (UFH) is associated with consistent outcomes in males and females with acute coronary syndrome (ACS) undergoing invasive management. METHODS AND RESULTS: In the MATRIX programme, 7,213 patients were randomised to bivalirudin or UFH. Patients in the bivalirudin group were subsequently randomly assigned to receive or not a post-PCI bivalirudin infusion. The 30-day co-primary outcomes were major adverse cardiovascular events (MACE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACE or major bleeding. The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target vessel revascularisation (TVR), definite stent thrombosis (ST), or NACE. The rate of MACE was not significantly lower with bivalirudin than with heparin in male (rate ratio [RR] 0.90, 95% confidence interval [CI]: 0.75-1.07; p=0.22) and female patients (RR 1.06, 95% CI: 0.80-1.40; p=0.67) without significant interaction (pint=0.31), nor was the rate of NACE (males: RR 0.85, 95% CI: 0.72-1.01; p=0.07; females: RR 0.98, 95% CI: 0.76-1.28; p=0.91; pint=0.38). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent TVR, definite ST, or NACE (males: RR 0.84, 95% CI: 0.66-1.07; p=0.15; females: RR 1.06, 95% CI: 0.74-1.53; p=0.74; pint=0.28). CONCLUSIONS: In ACS patients, the rates of MACE and NACE were not significantly lower with bivalirudin than with UFH in both sexes. The rate of the composite of urgent TVR, definite ST, or NACE was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion in both sexes.

2-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease: Evidence From the SFA-Long Study.

OBJECTIVES: The aim of this study was to appraise 2-year outcomes after percutaneous transluminal angioplasty of long femoropopliteal artery disease using paclitaxel-coated balloons (PCBs). BACKGROUND: Percutaneous transluminal angioplasty with PCBs for TransAtlantic Inter-Society Consensus types C and D femoropopliteal artery disease has provided favorable results ≤12 months but no prospective studies performed longer term follow-up assessment. METHODS: Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency (i.e., freedom from the combined endpoint of clinically driven target lesion revascularization and >50% restenosis in the treated lesion as appraised by a duplex ultrasound peak systolic velocity ratio of >2.4) at 24 months. Secondary endpoints included major adverse events (the composite of death, target limb amputation, thrombosis at the target lesion, or clinically driven nontarget lesion revascularization), changes in Rutherford class, and quality of life ≤24 months post-procedure. RESULTS: A total of 105 patients (age 68 ± 9 years; 81.9% men) successfully treated with PCBs were included (treated lesion length was 251 ± 71 mm; 49.5% total occlusions). The 24-month follow-up data were available in 98 patients; they showed a primary patency rate of 70.4%, with major adverse events occurred in 10 patients (10.2%, 5 non-procedure-related deaths) and persistently significant clinical benefits in Rutherford class (51% of asymptomatic patients at 24 months). CONCLUSIONS: PCBs benefits on primary patency and target vessel revascularization satisfactorily extend over 24 months in patients undergoing percutaneous transluminal angioplasty for symptomatic femoropopliteal disease.

1-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease: Evidence From the SFA-Long Study.

OBJECTIVES: The aim of this study was to appraise 1-year outcomes after percutaneous treatment of long femoropopliteal artery disease using paclitaxel-coated balloons. BACKGROUND: Percutaneous transluminal angioplasty with paclitaxel-coated balloons for TransAtlantic Inter-Society Consensus types A and B femoropopliteal artery disease has provided favorable results. METHODS: Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long and with 4- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency at 12 months. Secondary endpoints included major adverse events (the composite of death, major target limb amputation, thrombosis at the target lesion site, or clinically driven non-target lesion target vessel revascularization), changes in Rutherford class, ankle-brachial index, and quality of life up to 24 months post-procedure. RESULTS: A total of 105 patients (mean age 68 ± 9 years, 81.9% men) treated with paclitaxel-coated balloons and provisional stenting were enrolled, and final procedural success was obtained in all. The mean treated lesion length was 251 ± 71 mm, including 63.4% moderate to severely calcified lesions and 49.5% total occlusions. The bailout stent rate was 10.9%. Follow-up after 12 months was obtained in 101 patients (96.2%), showing that primary patency was maintained in 84 (83.2%), and major adverse events had occurred in 7 (6.2%), with persistently significant clinical benefits in Rutherford class. CONCLUSIONS: Paclitaxel-coated balloons are associated with favorable functional and clinical outcomes at 1 year in patients with long femoropopliteal artery disease requiring percutaneous revascularization. (Drug Eluting Balloon [DEB] and Long Lesions of Superficial Femoral Artery [SFA] Ischemic Vascular Disease [DEB-SFA-LONG]; NCT01658540).

Bivalirudin or unfractionated heparin in patients with acute coronary syndromes managed invasively with and without ST elevation (MATRIX): randomised controlled trial.

OBJECTIVE:  To test the optimal antithrombotic regimen in patients with acute coronary syndrome. DESIGN:  Randomised controlled trial. SETTING:  Patients with acute coronary syndrome with and without ST segment elevation in 78 centres in Italy, the Netherlands, Spain, and Sweden. PARTICIPANTS:  7213 patients with acute coronary syndrome and planned percutaneous coronary intervention: 4010 with ST segment elevation and 3203 without ST segment elevation. The primary study results in the overall population have been reported previously. INTERVENTIONS:  Patients were randomly assigned, in an open label fashion, to one of two regimens: bivalirudin with glycoprotein IIb/IIIa inhibitors restricted to procedural complications or heparin with or without glycoprotein IIb/IIIa inhibitors. MAIN OUTCOME MEASURES:  Primary endpoints were the occurrence of major adverse cardiovascular events, defined as death, myocardial infarction or stroke; and net adverse clinical events, defined as major bleeding or major adverse cardiovascular events, both assessed at 30 days. Analyses were performed by the principle of intention to treat. RESULTS:  Use of a glycoprotein IIb/IIIa inhibitor in patients assigned to heparin was planned at baseline in 30.7% of patients with ST segment elevation, in 10.9% without ST segment elevation, and in no patients assigned to bivalirudin. In patients with ST segment elevation, major adverse cardiovascular events occurred in 118 (5.9%) assigned to bivalirudin and 129 (6.5%) assigned to heparin (rate ratio 0.90, 95% confidence interval 0.70 to 1.16; P=0.43), whereas net adverse clinical events occurred in 139 (7.0%) patients assigned to bivalirudin and 163 (8.2%) assigned to heparin (0.84, 0.67 to 1.05; P=0.13). In patients without ST segment elevation, major adverse cardiovascular events occurred in 253 (15.9%) assigned to bivalirudin and 262 (16.4%) assigned to heparin (0.97, 0.80 to 1.17; P=0.74), whereas net adverse clinical events occurred in 262 (16.5%) patients assigned to bivalirudin and 281 (17.6%) assigned to heparin (0.93, 0.77 to 1.12; P=0.43). CONCLUSIONS:  A bivalirudin monotherapy strategy compared with heparin with or without glycoprotein IIb/IIIa inhibitors, did not result in reduced major adverse cardiovascular events or net adverse clinical events in patients with or without ST segment elevation.Trial Registration ClinicalTrials.gov NCT01433627.

Early and mid-term outcomes of 1904 patients undergoing transcatheter balloon-expandable valve implantation in Italy: results from the Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER).

OBJECTIVES: The aim of this multicentre study is to report the clinical experiences of all patients undergoing transcatheter aortic valve implantation (TAVI) with a balloon-expandable device in Italy. METHODS: The Italian Transcatheter balloon-Expandable valve Registry (ITER) is a real-world registry that includes patients who have undergone TAVI with the Sapien (Edwards Lifesciences, Irvine, CA, USA) bioprosthesis in Italy since it became available in clinical practice. From 2007 to 2012, 1904 patients were enrolled to undergo TAVI in 33 Italian centres. Outcomes were classified according to the updated Valve Academic Research Consortium (VARC-2) definitions. A multivariable analysis was performed to identify independent predictors of all-cause mortality. RESULTS: Mean age was 81.7 (SD:6.2) years, and 1147 (60.2%) patients were female. Mean Logistic EuroSCORE was 21.1% (SD:13.7). Transfemoral, transapical, transaortic and transaxillary TAVI was performed in 1252 (65.8%), 630 (33.1%), 18 (0.9%) and 4 (0.2%) patients, respectively. Operative mortality was 7.2% (137 patients). The VARC-2 outcomes were as follows: device success, 88.1%; disabling stroke, 1.0%; life-threatening and major bleeding 9.8 and 10.5%, respectively; major vascular complication, 9.7%; acute kidney injury, 8.2%; acute myocardial infarction ≤72 h, 1.5%. Perioperative pacemaker implantation was necessary in 116 (6.1%) patients. At discharge, the mean transprosthetic gradient was 10.7 (SD:4.5) mmHg. Incidence of postoperative mild, moderate or severe paravalvular leak was, respectively, 32.1, 5.0 and 0.4%. A total of 444/1767 (25.1%) deaths after hospital discharge were reported: of these, 168 (37.8%) were classified as cardiac death. Preoperative independent predictors of all-cause mortality were male gender (HR: 1.395; 95% CI:1.052-1.849); overweight, BMI 25-30 kg/m2 (HR: 0.775; 95% CI: 0.616-0.974); serum creatinine level (every 1 mg/dl increase; HR: 1.314; 95% CI:1.167-1.480); haemoglobin level (every 1 g/dl increase; HR: 0.905; 95% CI:0.833-0.984); critical preoperative state (HR: 2.282; 95% CI: 1.384-3.761); neurological dysfunction (HR: 1.552; 95% CI:1.060-2.272); atrial fibrillation (HR: 1.556; 95% CI:1.213-1.995); pacemaker rhythm (HR: 1.948; 95% CI:1.310-2.896); NYHA Class III or IV (HR: 1.800; 95% CI:1.205-2.689 or HR: 2.331; 95% CI:1.392-3.903, respectively). CONCLUSIONS: TAVI with a balloon-expandable device in the 'real world' shows good mid-term outcomes in terms of survival, technical success, valve-related adverse events and haemodynamic performance.

Emergency coronary and peripheral arteries combined with percutaneous intervention in the elderly: success or therapeutic excess?

Acute lower extremities peripheral artery disease represents a clinical emergency. Peripheral artery disease incidence ranges from 2.5 to 22% and has progressively increased due to the world population aging phenomenon and associates with coronary artery disease with a rate of 40-60%. The authors present the case of an 89-year-old man coming to their attention with acute lower extremities ischemia and unstable angina. Despite the short-to-midterm favorable outcome, doubts remain about the opportunity of treating 'very old' patients. The lack of dedicated randomized trials and of defined guidelines is a problem the scientific community needs to face considering that patients over 85 years represent a raising quote of the whole population of our catheterization laboratories.

2-year results of paclitaxel-eluting balloons for femoropopliteal artery disease: evidence from a multicenter registry.

OBJECTIVES: This study aimed to appraise 2-year outcomes after percutaneous treatment of femoropopliteal artery disease with paclitaxel-eluting balloons. BACKGROUND: Percutaneous transluminal angioplasty with paclitaxel-eluting balloons for femoropopliteal artery disease has provided favorable 1-year results. METHODS: Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions ≤15 mm long and with 3- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter registry. Endpoints of interest included primary patency, major adverse events (the composite of death, amputation, or target lesion revascularization), changes in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life after ≥24 months. RESULTS: A total of 105 patients (114 lesions) treated with paclitaxel-eluting balloons and provisional stenting were enrolled, and final procedural success was obtained in all. Follow-up after 27 ± 3 months was obtained in 98 (93.3%) patients, showing that primary patency was maintained in 71 (72.4%), and major adverse events had occurred in 17 (17.5%), with persistently significant benefits in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life (all p < 0.001). Secondary patency rate was achieved in 89 cases (84.7%). CONCLUSIONS: PEBs are associated with favorable functional and clinical outcomes at 2 years in patients with femoropopliteal artery disease requiring percutaneous revascularization.

Clinical evaluation of a paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease: 12-month results from a multicenter Italian registry.

OBJECTIVES: This study evaluated the use of a paclitaxel-eluting balloon (PEB) for treatment of femoropopliteal arterial disease. BACKGROUND: Conventional balloon angioplasty and stenting in this setting is associated with high restenosis rates within 12 months. Recent data suggest that PEB use may reduce restenosis. Twelve-month outcomes following PEB use with provisional stenting are described. METHODS: This prospective registry enrolled patients (Rutherford class 2 to 4) with reference vessel diameter of 3 to 7 mm and lesion/occlusion length ≤ 15 cm. Endpoints included primary patency rate, target lesion revascularization, and changes in Rutherford class and ankle-brachial index. Walking capacity, absolute claudication distance, and quality of life were also assessed. RESULTS: The registry enrolled 105 patients. Baseline ankle-brachial index was 0.56 ± 0.15. Baseline Rutherford classification was class 2 or 3 for most patients (91.5%). Most lesions were located in the superficial femoral artery (77.1%). Mean lesion length was 76.3 ± 38.3 mm; 29.8% of lesions were total occlusions. The device was successfully used in all patients and only 12.3% of lesions required stenting. At 12-month follow-up, 92 of 105 patients (87.6%) were evaluable; the primary patency rate was 83.7%; the target lesion revascularization rate was 7.6%; 85.6% of patients were Rutherford class 0 or 1; and mean ankle-brachial index was 0.86 ± 0.15. Quality of life and absolute claudication distance showed significant improvement from baseline to 12-month follow-up. CONCLUSIONS: PEB treatment of femoropopliteal arterial disease resulted in consistent clinical improvement across multiple endpoints with a low rate of stenting and target lesion revascularization.

Safety, efficacy and long-term durability of endovascular therapy for carotid artery disease: the tailored-Carotid Artery Stenting Experience of a single high-volume centre (tailored-CASE Registry).

AIMS: We aimed to determine the success, safety and long-term durability of carotid artery stenting (CAS) in stroke prevention for all-comers managed with mandatory neuroprotection and a tailored-approach to intervention. METHODS AND RESULTS: From our CAS registry (beginning July 1997) all procedures up to September 2007 with intention-to-treat by stenting under distal filter or proximal occlusion neuroprotection devices were analysed (N=1523; mean age 72 years [237 >or=80 years, 15.5%]). Indications included symptomatic stenoses >or=50% (366, 24.1%) and asymptomatic stenoses >or=80% (1157, 75.9%). CAS success was 99.6% and the 30-day all-stroke/death rate was 1.5% (minor stroke 11 [0.7%], major stroke 8 [0.5%], death 5 [0.3%]). The risk was 1.2% for asymptomatic patients and 2.7% for symptomatic patients (p=0.042). Regarding octogenarians this risk was 2.1% versus 1.5% for patients or=80 1.2%, symptomatic or=80 4.5%. The event free survival rates from all strokes or stroke-related deaths at eight years were 96% for asymptomatic and 92% for symptomatic patients. CONCLUSIONS: Results from this large cohort show that carotid stenting in a real-world setting is safe and efficacious, and durable in the long-term prevention of stroke.

Patient selection to enhance the long-term benefit of first generation drug-eluting stents for coronary revascularisation procedures. Insights from a large multicentre registry.

AIMS: To evaluate the long-term clinical outcome after drug-eluting stents (DES) implantation, and to test if patient selection could enhance their net clinical benefit. METHODS AND RESULTS: We assessed the incidence of major adverse cardiac events (MACE=death, acute myocardial infarction, and target vessel revascularisation, TVR) and angiographic stent thrombosis (ST) during 3-year follow-up in a prospective multicentre registry. Propensity-score analysis to adjust for different clinical, angiographic and procedural characteristics was performed. Overall, 14,115 patients enrolled in the registry received solely BMS (n=9,565) or DES (n=4,550). The incidence of definite ST was 0.6% for BMS and 1.3% for DES (p=0.003). The propensity-score adjusted incidence of cardiac death and myocardial infarction was similar between the two groups (DES 11.9% vs. BMS 12.1%, HR 0.90, 95% CI 0.77-1.04), whereas DES were associated with lower rates of TVR (DES 11.6% vs. BMS 15.2%, HR 0.67, 95% CI 0.59-0.76). The efficacy of DES in reducing TVR increased with increasing likelihood of TVR at baseline. CONCLUSIONS: The beneficial effect of DES in reducing new revascularisations compared to BMS extends out to three years without a significantly worse overall safety profile. The benefit seems more evident in patients with the highest baseline risk of clinical restenosis.

Stent migration as a late complication following carotid angioplasty and stenting.

BACKGROUND: A 69-year-old male patient with severe asymptomatic carotid artery stenosis was treated percutaneously with implant of two self-expandable stents in the right carotid overlapped to each other by 5 mm. The 15-month follow-up colour-Doppler ultrasound (CDU) revealed a severe stenosis in the target vessel and an image suggesting migration of the distal stent. INVESTIGATIONS: Physical examination, laboratory test, CDU, carotid angiography, quantitative carotid angiography (QCA), brain computed tomography (CT). DIAGNOSIS: Migration of the distal stent associated with severe stenosis on the unsupported arterial segment. MANAGEMENT: Carotid artery angiography, QCA, antithrombotic therapy, carotid artery angioplasty and stenting (CAS).

Endovascular treatment of soft carotid plaques: a single-center carotid stent experience.

PURPOSE: To report a prospective evaluation of the 30-day clinical neurological outcome in patients percutaneously treated for severe symptomatic and asymptomatic soft echolucent carotid plaques under cerebral protection from a proximal flow blockade system. METHODS: From December 2001 to February 2005, 84 consecutive patients (63 men; mean age 70.7 +/- 7.1 years, range 58-81) with documented soft echolucent (gray scale median < 25) extracranial carotid lesions were enrolled in a study of percutaneous stenting under cerebral protection achieved by a proximal endovascular clamping device. Primary endpoint of the study was the all stroke and death rate at 30 days. Secondary endpoints were angiographic success and any complication between discharge and 30 days. All adverse events were analyzed by an independent neurological team. RESULTS: Total neurological events at 30-day follow-up included 3 transient ischemic attacks and 1 minor stroke (4.8% neurological event rate). The 30-day rates of stroke and neurological death/stroke were both 1.2%; the all death/stroke rate was 2.4%. Clamping intolerance was observed in 5.9% of cases, but there was no interruption in the procedure or clinical sequelae. In 66.7% of patients, visible debris was collected during the procedure. CONCLUSION: Protected CAS with proximal flow blockage can successfully be applied in selected patients for soft carotid plaques at high risk for intraprocedural embolic events.

Impact of cerebral protection devices on early outcome of carotid stenting.

PURPOSE: To evaluate the impact of cerebral protection devices on the procedural safety and outcome of carotid stent procedures. METHODS: From June 1997 to July 2001, 275 consecutive patients (208 men; mean age 71 +/- 7.4 years) underwent percutaneous angioplasty and/or stenting of the extracranial carotid artery. In the first 125 (45.4%) patients, the procedures were performed without cerebral protection. After January 2000, protection devices were routinely used (150 [54.6%] patients), including the Angioguard filter, GuardWire occlusion system, TRAP Vascular Filtration System, EPI Filter Wire, NeuroShield, Parodi Anti-Embolism System, and Medicorp occlusive balloon. RESULTS: The percutaneous procedures were effective in 273 (99.3%) patients. No death or major stroke occurred in either group. In the unprotected group, 5 (4.0%) complications occurred: 3 (2.4%) minor strokes, 1 (0.8%) transient ischemic attack (TIA), and 1 (0.8%) subarachnoid hemorrhage. In the patients treated under cerebral protection, there were 2 (1.3%) complications: 1 (0.7%) minor stroke and 1 (0.7%) subarachnoid hemorrhage. There were 4 (3.2%) periprocedural embolic complications in the unprotected group versus 1 (0.7%) in the protected patients. CONCLUSIONS: Our data suggest that percutaneous dilation and stenting of the carotid arteries protected by cerebral protection devices is feasible and effective. In a consecutive series, the use of the cerebral protection systems reduced the acute neurological event rate related to embolic complications by 79%.