Four-year outcomes of a single-center experience with coronary everolimus-eluting bioresorbable scaffolds.

BACKGROUND: Bioresorbable scaffolds (BRS) have been introduced to overcome the limitations of drug-eluting stents and the ABSORB (Everolimus-Eluting BRS, Abbott Vascular, Santa Clara, CA, USA) was the most extensively tested. Nevertheless, major RCTs reported higher rates of target lesion failures and BRS thrombosis at 3 years follow-up, bringing to the withdrawing of the device from the market. It has been suggested that a better lesions selection and an optimized implantation technique could mitigate the displayed adverse results. METHODS: Consecutive patients undergoing BRS implantation were included in this observational, single center study. Clinical follow-up was conducted up to 4 years. Endpoint of interest was the target lesion failure (TLF), a composite outcome including cardiac death, target vessel myocardial infarction and target lesion revascularization. RESULTS: A total of 62 patients with a mean age of 55±8.5 years were analyzed of which 70.9% presented with an acute coronary syndrome and 59.6% with myocardial infarction. A total of 100 lesions were treated and 51.6% were complex (B2/C). Predilatation was performed in all the case, post-dilatation in 74.1%. All the target vessel reference diameter (RVD) were >2.5 mm (average RVD 3.2±0.24 mm). At 4 years, the rate for TLF was 6.9%. Subgroup's analysis did not show significative differences among groups although consistently higher event rates were found for RVD <2.5 mm (12.6% vs. 6.4%, P=0.5), BRS overlapping (11.8% vs. 5%, P=0.2) and ticagrelor instead of clopidogrel on top of cardioaspirin (9.1% vs. 3%, P=0.2). CONCLUSIONS: This small-sized real-world registry displays lower rates of clinical events during long-term follow-up in respect to previous studies. The avoidance of implantation in small vessels, inclusion of acute myocardial infarction and extensive performance of BRS post-dilatation could explain the observed better results. Long-term outcomes of the ongoing ABSORB IV Trial are needed to confirm this data.

[Simultaneous transcatheter transapical native mitral and aortic valve implantation]. / Sostituzione transcatetere transapicale simultanea delle valvole aortica e mitralica native.

Concomitant severe aortic and mitral stenosis in patients who are not candidates for traditional surgery is a complex scenario that becomes increasingly more common with population aging. While transcatheter aortic valve replacement (TAVR) has emerged as a new lifeline for patients with severe aortic stenosis who are at intermediate or high risk for surgical aortic valve replacement, transcatheter mitral valve replacement (TMVR) is still in the early clinical phase. TMVR can be an alternative to surgical valve replacement for high surgical risk patients with bioprosthetic mitral valves, annuloplasty rings, or severe mitral annular calcification (MAC). Despite the growing use of TMVR, left ventricular outflow tract obstruction remains a major challenge and a life-threatening complication of this procedure mostly among patients undergoing valve-in-MAC procedures. Preprocedural planning with imaging is essential in understanding and reducing the risk for these complications.We describe a case of simultaneous transcatheter double valve replacement into native valves from transapical access in a 77-year-old female patient with severe symptomatic aortic and mitral stenosis associated with MAC.

Results From the International Drug Coated Balloon Registry for the Treatment of Bifurcations. Can a Bifurcation Be Treated Without Stents?

OBJECTIVES: This observational study assessed the 9-month clinical outcomes in patients with coronary bifurcation lesions suitable for drug-coated balloon (DCB) angioplasty. It was the intention to use DCB's without additional stenting (DCB-only strategy) in selected patients for this chosen strategy. Bail-out main branch (MB) and/or side branch (SB) stenting, however, were permissible when flow limiting dissections or excessive recoil occurred. BACKGROUND: A multitude of interventional strategies have been studied to treat bifurcation lesions. With the availability of DCB angioplasty, investigators have been using this interventional tool with the optional implantation of bare metal stents (BMS). METHODS: This study is an international, prospective, multicenter registry enrolling patients with coronary bifurcation lesions including a side branch ≥2 mm in diameter. Patients with stable angina and documented ischemia or selected forms of unstable angina due to a culprit bifurcation lesion of any Medina classification type were recruited. The primary endpoint was clinically driven target-lesion revascularization (TLR) at 9 months. Secondary endpoints included 9-month major adverse cardiac events (death, myocardial infarction, or TLR), technical success, in-hospital outcomes and vessel thrombosis rates. RESULTS: A total 127 patients 66.1 ± 10.1 years of age were enrolled. Demographic characteristics were 80.3% (102/127) male gender, 31.5% (40/127) diabetes, 91.3% (116/127) hypertension, 7.1% (9/127) ST-elevation myocardial infarction (STEMI), and 9.4% (12/127) non ST-elevation myocardial infarction (NSTEMI). The 130 lesions were treated with 184 DCB's and 64 BMS. In 53.8% (70/130) of all lesions the DCB-only strategy could be used while 34.6% (45/130) of lesions had at least 1 stent (BMS) in the main branch, 8.5% (11/130) had at least 1 stent in the side branch and 3.1% (4/130) needed at least 1 stent in the main and side branch. 94.5% patients (121/127) were available for follow-up after 9.8 ± 2.0 months. The TLR rate was 4.6% in the absence of any thrombotic events in the treated vessels whereas the 9-month MACE rate was 6.2%. CONCLUSION: This observational study suggests that the DCB-only strategy is safe and effective to treat selected bifurcations while benefiting from a shortened dual antiplatelet therapy (DAPT).

How should I treat severe symptomatic aortic stenosis with transcatheter aortic valve implantation in a patient with right aortic arch?

BACKGROUND: An 84-year-old man suffering from dyspnoea on mild exertion and a 10-year history of mitral valve replacement with a mechanical prosthesis presented to our department. The patient had an isolated right aortic arch. INVESTIGATION: Transthoracic echocardiography demonstrated severe LV systolic dysfunction (EF 25%), good function of the previously implanted mechanical prosthesis and severe aortic stenosis. Multislice computed tomography confirmed the presence of an isolated right aortic arch with mirror-image branching. DIAGNOSIS: Severe symptomatic aortic stenosis in a patient with right aortic arch at high risk for surgical reintervention. MANAGEMENT: Transcatheter aortic valve implantation using conventional delivery system.

Left atrial remodelling in patients undergoing transcatheter aortic valve implantation: a speckle-tracking prospective, longitudinal study.

Aortic stenosis (AS) results in several left ventricular (LV) disturbances as well as progressive left atrial (LA) enlargement and dysfunction. Transcatheter aortic valve implantation (TAVI) reverses LV remodelling and improves overall systolic function but its effect on LA function remains undetermined. The aim of this prospective, longitudinal study was to investigate the effects of TAVI on LA structure and function. We studied thirty-two patients with severe symptomatic AS who underwent TAVI, using standard and 2-dimensional speckle-tracking echocardiography before, at 40-day and at 3-month follow-up. Following TAVI, mean transvalvular gradient decreased (p < 0.001). Both LA area index and LA volume index decreased at 40-day follow-up (16.2 ± 6.4 vs. 12.5 ± 2.9 cm2/m2, and 47.3 ± 12.0 vs. 42.8 ± 12.5 mL/m2, respectively, p < 0.05) and values remained unchanged at 3 months. The reduction of LA size was accompanied by a significant increase in global peak atrial longitudinal strain (14.4 ± 3.9 vs. 19.1 ± 4.7%, p < 0.001) and in global peak atrial contraction strain (8.4 ± 2.5 vs. 11.0 ± 4.1%, p < 0.05) at 3-month follow-up. LA stiffness measurements significantly decreased 3 months after TAVI (0.93 ± 0.59 vs. 0.65 ± 0.37, respectively, p < 0.001). Trans-aortic mean gradient change and pre-procedural LA volume were identified as predictors of global peak atrial longitudinal strain increase (ß = -0.41, ß = -0.35, respectively, p < 0.0001) while pre-procedural LA volume and trans-aortic mean gradient change as predictor of LA volume index reduction 3 months after TAVI (ß = -0.37, ß = -0.28, respectively, p < 0.0001). TAVI is associated with significant recovery of LA structure and function suggesting a reverse cavity remodelling. Such functional recovery is primarily determined by the severity of pre-procedural valve stenosis.

Improvement of left ventricular longitudinal systolic function after transcatheter aortic valve implantation: a speckle-tracking prospective study.

Transcatheter aortic valve implantation (TAVI) is able to determine a significant improvement of left ventricular ejection fraction (LVEF). The variations of LV global longitudinal strain (GLS) have not been yet investigated in TAVI patients with reduced LVEF. The aim of this study was to determine the effects of TAVI on LV function by 2D speckle-tracking echocardiography (STE) in patients with reduced LVEF. Eighteen consecutive patients undergoing TAVI in our centre were prospectively enrolled. Echocardiography was performed pre-procedurally the day of TAVI and at 40-day and 3-month follow-up (FU). The mean age of TAVI patients was 79.75 ± 7.68 years. The mean EuroSCORE was 26.59 ± 14.62%. A significant decrease of mean trans-aortic gradient was observed 40 days after TAVI (51.69 ± 18.82 vs. 9.62 ± 3.28 mmHg, p < 0.0001). LV mass index significantly decreased at 40-day FU (165.72 ± 37.75 vs. 145.52 ± 31.32 g/m(2), p < 0.001) with a further reduction at 3-month FU (136.91 ± 26.91 g/m(2), p < 0.05 in comparison with 40-day FU). The mean pre-procedural LVEF was 45.87 ± 7.95%. LVEF significantly increased at 40-day FU (55.20 ± 5.91%, p < 0.05) and remained stable at 3-month FU (55.58 ± 6.14%). Interestingly, an early improvement of LV GLS was observed at 40-day FU (-11.09 ± 3.40 vs. -14.40 ± 3.68%, p < 0.001) with a slight further increase at 3-month FU (-14.71 ± 3.56%). Our results indicate that significant improvements of LVEF and LV GLS can be observed in patients undergoing TAVI with impaired LVEF. Two-dimensional STE was able to detect the reverse remodeling of LV function, adding further insights into the assessment of LV mid-term recovery after TAVI.

Long-term outcome after drug-eluting stents implantation: target lesion versus nontarget lesion repeated intervention.

We sought to investigate the relative clinical significance of target and nontarget lesions repeated percutaneous coronary intervention (re-PCI) in patients implanted with drug-eluting stents (DES). Out of 2626 consecutive DES patients, we retrospectively selected 166 (6.3%; 123 males, aged 65±10 years) who had a clinically-driven re-PCI over a mean follow-up of 15 months. Seventy-five patients (45%) underwent the second procedure for disease progression in nontarget lesions (nontarget lesion re-PCI group) while 91 (55%) showed target lesion in-stent restenosis or thrombosis (target lesion re-PCI group), with no significant intergroup difference in the temporal trends of re-PCI. The prevalence of stable coronary artery disease and acute coronary syndromes (ACS) was 22% and 78% in the target lesion re-PCI vs. 81% and 19% in the nontarget lesion re-PCI group (overall p<0.001), respectively. In-stent restenosis accounted for 75% of second procedures in the target lesion re-PCI group and presented as an ACS in 72% of cases. The need for a new PCI in DES patients is relatively low in a real world setting. Stent-related events in the target lesion and progression of disease in nontarget lesions account to a similar extent for re-PCI, although their clinical presentation is strikingly different. The most common presentation of events related to previously treated lesions is an unstable syndrome, which provides support to the concept that also restenosis in a DES should not be considered a clinically benign entity.

Beneficial effect of post-procedural abciximab in patients undergoing primary coronary angioplasty and presenting with the no-reflow phenomenon.

We sought to investigate the effect of post-procedural abciximab on clinical outcome of patients presenting the no-reflow phenomenon after primary angioplasty. We retrospectively selected 38 patients who developed the no-reflow phenomenon after primary angioplasty: 18 received post-procedural abciximab, 20 age- and sex-matched patients who did not receive abciximab were considered as concurrent controls. At 6 months follow-up, the clinical course was uneventful in the abciximab group while the composite end-point of major adverse cardiac events occurred in 8 patients (40%) in the control group (P=0.009). 'Rescue' administration of abciximab is an effective option for the treatment of the no-reflow phenomenon determining significant prognostic improvements.

Symptomatic failure after sirolimus-eluting stent implantation: a rare but challenging condition.

BACKGROUND: Limited information is available regarding restenosis after implantation of a sirolimus-eluting stent (SES). OBJECTIVE: To report on angiographic characteristics, clinical presentation and treatment of this particularly complex type of coronary lesion. METHODS AND RESULTS: A total of 1424 SES were implanted in 1159 patients (average 1.2 per patient) for chronic or acute coronary syndromes in the University Hospital of Siena (Siena, Italy), which is a tertiary centre. Symptomatic in-SES restenosis was observed in 26 patients (2.2%) at 10+/-5 months (median eight months, range four to 23 months) following the initial intervention. In-SES restenosis was associated with stable angina in 16 patients, acute myocardial infarction in three patients and unstable angina in seven patients. Two patients had restenosis in two separate SES. Conditions often associated with in-SES restenosis included treatment of chronic total occlusion, geographic miss or in-stent restenosis during the index procedure. Among the first 20 patients, those with focal, in-body SES (type Ic) restenosis received balloon-only angioplasty, and patients with other patterns received repeat SES implantation. Clinical and angiographic follow-up (average 16+/-7 months) recorded one death (noncardiac) in the balloon-only group and four cases of unstable angina (three due to relapsing in-SES restenosis in the balloon-only group and the fourth due to a de novo lesion). Follow-up quantitative angiography showed a higher incidence of binary restenosis after balloon-only treatment (57% versus 17%; P<0.05), as well as higher lumen loss and loss index (P<0.05). CONCLUSIONS: Restenosis after SES implantation occurs more commonly in a focal pattern in-body or at the proximal edge of the stent. Repeat SES implantation appears to be a safer and more effective therapeutic choice than balloon-only angioplasty.

Effectiveness and safety of sirolimus stent implantation for coronary in-stent restenosis: the TRUE (Tuscany Registry of Sirolimus for Unselected In-Stent Restenosis) Registry.

OBJECTIVES: This study sought to evaluate the effectiveness and safety of the sirolimus-eluting stent in the treatment of in-stent restenosis (ISR) in consecutive unselected patients undergoing coronary intervention in a real-world scenario. BACKGROUND: Restenosis after bare metal stenting is characterized by a high rate of re-restenosis once treated with repeated percutaneous coronary intervention. METHODS: The study was designed as a prospective two-center registry. We enrolled 244 patients with ISR in a native coronary artery or saphenous vein graft who had clinical indication for repeat intervention. RESULTS: Sirolimus stent implantation was successful in all lesions. At 9-month follow-up, death occurred in 4 (1.6%) patients, myocardial infarction in 4 (1.6%), and ischemia-driven target lesion revascularization (TLR) in 12 (4.9%), for a cumulative event-free survival of 227 (93%). Although 9-month follow-up angiography was planned in all patients, only 150 (62%) patients completed it, and restenosis was present in 13 (8.7%) patients. Diabetes and non-ST-segment elevation acute coronary syndrome at presentation were the only independent predictors of freedom from ischemia-driven TLR and major adverse cardiac events. CONCLUSIONS: Sirolimus stent implantation for the treatment of ISR is effective and safe. In diabetic patients and in those with acute coronary syndrome, the higher rate of recurrence requires further evaluation.

Outcome of percutaneous hybrid coronary revascularization: bare metal stents jeopardize the benefit of sirolimus-eluting stents in the real world.

BACKGROUND: In an effort to contain procedural costs while limiting the risk of in-stent restenosis, hybrid percutaneous revascularization (ie, stenting with at least one sirolimus-eluting stent [SES] and at least one bare metal stent [BMS] in the same patient) is felt to be a cost-effective alternative to exclusive SES use. OBJECTIVE: To describe the outcome of hybrid percutaneous revascularization for the treatment of patients with multiple coronary artery lesions. METHODS AND RESULTS: Fifty-six patients (42 men; mean age [+/- SEM] 64+/-2) underwent hybrid stenting (average of 1.2 SES/patient and 1.3 BMS/patient). SES were used to treat lesions at higher restenotic potential, including longer lesions, smaller target vessels and bifurcation lesions (mean stent length [+/- SEM] was 21.1+/-1.2 mm for SES and 16.0+/-0.6 mm for BMS; stent diameter mean [+/- SEM] was 2.9+/-0.0 mm for SES and 3.1+/-0.1 mm for BMS; bifurcation lesions were 43% for SES and 7% for BMS; all P<0.01). At nine months of clinical follow-up, no death or myocardial infarction was reported. Twenty-one patients underwent clinically driven repeat coronary angiography at a mean (+/- SEM) of 8+/-1 of months (range two to 12 months) follow-up. Target lesion revascularization procedures were recorded in six patients (11%) for nine lesions (6%). Of these lesions, seven were categorized after blinded analysis as due to in-BMS restenosis and two to in-SES restenosis (P=0.01); three patients (5.4%) underwent reangioplasty for de novo lesions. There was one case of acute in-SES thrombosis. SES showed significantly less neointimal hyperplasia (late lumen loss was 0.4+/-0.1 mm for SES and 1.3+/-0.1 mm for BMS; loss index was 0.15+/-0.05 for SES and 0.48+/-0.05 for BMS; all P<0.001). CONCLUSIONS: The use of SES resulted in less neointimal hyperplasia even when used to treat lesions at higher risk for restenosis based on angiographic characteristics. BMS implantation significantly limits this beneficial effect, compromising the outcome of hybrid percutaneous coronary revascularization.

Bone mass loss in calcium stone disease: focus on hypercalciuria and metabolic factors.

BACKGROUND: Several authors have observed that idiopathic calcium stone formers show a bone mass reduction, which is more evident in those with idiopathic hypercalciuria. The aim of this work was the evaluation of osteopenia and osteoporosis rate in a group of idiopathic calcium stone formers. The influence of hypercalciuria, nutritional factors and anthropometric parameters on bone mass was evaluated in these patients as well. METHODS: We enrolled 196 idiopathic calcium stone formers; 102 males, and 94 females. All subjects underwent a metabolic study. BMC and BMD were evaluated as well as QUS. RESULTS: Males showed greater weight, height, BMI, densitometric values and plasma creatinine, uric acid, urea, sodium, magnesium, GFR and urinary osmolarity than females. Moreover males excreted more uric acid, urea, creatinine, sulphate, phosphate, oxalate and citrate than females. The prevalence of osteopenia and osteoporosis, according to T-score, was 54% and 14% respectively. Hypercalciuria was demonstrated in 21.7% of the patients. Hypercalciuric men showed a higher excretion of urea, phosphate, sulphate and magnesium. CONCLUSIONS: Our results confirm the importance of QUS in the evaluation of stone formers' bone mass. Anthropometric characteristics and dietary habits seem to play a role in bone loss. We did not demonstrate any influence of hypercalciuria on bone mass. Although the pathogenesis of bone loss in stone formers still remains unclear, it can be hypothesized that a slight degree of metabolic acidosis, probably of alimentary origin, may be involved in the reduction of bone mass.