Transcatheter aortic valve intervention in hospitals without cardiac surgery departments: a future scenario?

Transcatheter Aortic Valve Intervention (TAVI) was introduced in early 2000 to offer treatment to inoperable patients with severe aortic valve stenosis. In a couple of decades, the procedure resulted effective and safe also in patients with intermediate to low risk for surgery; therefore, due to the progressive ageing of the population, the clinical need for TAVI is continuously increasing and is hardly met by the availability of the procedure, the so-called "TAVI capacity". As a result, many patients encounter difficulties in being referred to TAVI centers or face long waiting list times, thus risking severe adverse events (including death) before the procedure is performed. Although contemporary guidelines and consensus documents recommend that TAVI should be only performed in hospitals with active cardiac surgery departments, starting TAVI programs also in interventional cardiac laboratories without on-site cardiac surgery could represent a way to increase TAVI capacity, thus leading to a greater number of patients being treated in less time. On the other side of the coin, such a strategy may jeopardize patient safety in case of periprocedural complications needing bailout surgery and may lead to a suboptimal multidisciplinary Heart Team evaluation. This review aims to assess and discuss available clinical data and implementation of TAVI programs in hospitals without on-site active cardiac surgery departments considering the growing unmet clinical need and technical advancement of TAVI platforms, yet not overlooking the recommendation of international scientific societies.

Major adverse cardiovascular event (MACE) after percutaneous coronary intervention in one-year follow-up study.

BACKGROUND: Percutaneous coronary intervention (PCI) is the most common revascularization procedure, with over 1 million performed each year, worldwide. Over the past 20 years, the increasing experience of operators coupled with the advent of newer technologies, including coronary stents and a variety of adjuvant drug therapies, have permitted more successful procedures and decreased the morbidity associated with PCIs. OBJECTIVE: To identify the incidence, predictors, and clinical implications of Major Adverse Cardiovascular Events (MACE) after PCIs. METHODS: This descriptive cross-sectional study was done in Bandar Abbas in Iran in 2015. All patients which treated with PCI in Shahid Mohammadi Hospital during a one-year period were employed. A total of 192 patients were included. At one-year follow-up in this study, incidence and predictors of MACE were evaluated in a prospective study. The data were analyzed by SPSS 19.0 and descriptive tests included frequency and percentage and mean and standard deviation. Also, Chi-square test was used for data analysis. A p value <0.05 was determined as significant. RESULT: Of the 192 patients, 126 (65.6%) were men and 66 patients were female. Stent had been implemented in 93.8% of patients. Sixty two percent of patients were treated with only one stent, two stents were deployed in 29.7% of patients and 3.6% of patients were treated with three or more stents. Of these patients, 46.9% were treated with Drug Eluted Stent (DES) and 40.1% were treated with Bare Metal Stent (BMS). Both types of stents were used in 8.3% of patients. Also, 4.7% of the patients were treated with balloon angioplasty (POBA). Angioplasty success rate was 95.3% and procedural success rate defined as achieving TIMI III flow with residual coronary stenosis under 30%. No in-hospital mortality or emergency CABG was reported. Re-admission in first year after PCI was required in 34 (17.7%) patients of which, 20 of them (10.4%) needed target vessel revascularization (TVR). Readmission was significantly higher (p=0.034) in the group with BMS compared to those who had DES. MI occurred in 8 patients. CONCLUSION: Our study showed the superiority of DES in comparison with BMS in decreasing readmission and less TVR, but no effect on long term mortality. We recommend more studies in this setting because patients in special groups may benefit more from DES or BMS.

Polymer-free amphilimus-eluting stent versus biodegradable polymer biolimus-eluting stent in patients with and without diabetes mellitus.

OBJECTIVES: This study sought to compare clinical outcome of polymer-free amphilimus-eluting stent (PF-AES) versus biodegradable-polymer biolimus-eluting stent (BD-BES) in "all-comer" diabetes mellitus (DM) and non-DM patients who underwent percutaneous coronary intervention. BACKGROUND: The PF-AES has shown promising preliminary results in patients with DM. METHODS: Data from 2 multicentre-national registries (the ASTUTE and the INSPIRE-1) were used to analyse 1776 patients stratified in non-DM and DM. A double 1:1 propensity-score matched analysis (PF-AES vs. BD-BES) was performed in each group to adjust for clinical and procedural characteristics. Primary stent-efficacy and stent-safety endpoints were 1-year target-lesion revascularization (TLR) and target-lesion failure (TLF, composed of cardiac-death, target-vessel myocardial infarction and any TLR). RESULTS: After propensity-score matching, 850 patients were stratified as non-DM (425 PF-AES/425 BD-BES) and 480 as DM patients (240 PF-AES/240 BD-BES). Both TLF (20 of 425 [5%] vs. 24 of 425 [6%]; Plog-rank=0.527) and TLR (9 of 425 [2%] vs. 18 of 425 [4%]; Plog-rank=0.079) were similar between PF-AES and BD-BES in non-DM patients. In DM, TLF (12 of 240 [5%] vs. 31 of 240 [13%]; Plog-rank=0.002) and TLR (9 of 240 [4%] vs. 21 of 240 [9%]; Plog-rank=0.019) were significantly lower in PF-AES compared to BD-BES. Upon multivariate analysis, the most powerful predictors of TLF were chronic kidney disease in non-DM (OR 4.24, 95% CI: 2.07-8.70, p<0.001) and stent type in DM patients (OR 2.76, 1.36-5.56, p=0.005). CONCLUSIONS: This matched-cohort study suggests that PF-AES has better safety and efficacy profile than BD-BES in patients with DM.

Large Left Ventricular Aneurysm and Multifocal Myocardial Involvement in a Patient With Systemic Sclerosis.

A 43-year-old man with systemic sclerosis and chest pain had negative T waves in precordial electrocardiographic leads. The echocardiogram showed a large left ventricular apical accessory chamber. The coronary arteries were normal. Cardiac magnetic resonance imaging (MRI) showed a large fibrotic aneurysm and a small patch of midwall late enhancement in the septum. The aneurysm was surgically removed. At the 8-month follow-up, cardiac MRI showed the appearance of a new nodular lesion in the anterior wall, causing a localized wall motion abnormality. Myocardial involvement in patients with systemic sclerosis can be severe, and cardiac MRI evaluation is fundamental.

Midterm and one-year outcome of amphilimus polymer free drug eluting stent in patients needing short dual antiplatelet therapy. Insight from the ASTUTE registry (AmphilimuS iTalian mUlticenTer rEgistry).

BACKGROUND: To assess clinical outcomes of patients needing short dual antiplatelet therapy (S-DAPT) after PCI with Cre8 polymer-free amphilimus eluting-stent (AES). The Cre8-AES with pure i-Carbofilm coating was supposed to induce faster stent endothelialization and reduce device thrombogenicity. METHODS: We performed a sub-analysis of unrestricted consecutive patients treated with Cre8-AES between August 2011 and January 2015. Two groups were formed: 1) patients discharged with S-DAPT (≤3-month), because of high bleeding risk or attending urgent non-cardiac surgery; and 2) patients discharged with Recommended DAPT duration (R-DAPT; ≥6-month). The primary ischemic- and bleeding-safety endpoints were Target Vessel Failure (TVF, composite endpoint of cardiac-death, target vessel-myocardial infarction and target vessel-revascularization), and major-bleeding (BARC ≥type-3a) at 6-month and 1-year. RESULTS: 106 patients (8.7%) were discharged with ≤3-month DAPT (83±19days; S-DAPT group) and 1102 patients (90.6%) with ≥6-month DAPT (342±62days; R-DAPT group). Between S-DAPT and R-DAPT groups no significant differences were observed in TVF at 1-year (5.7% vs 5.1%); 1-year BARC major bleeding rate was higher in S-DAPT group (3.4% vs 0.2%, p=0.007) with all bleeding events occurred within 3months. The landmark analysis (started at 90days, ended at 1year) showed no differences in BARC major bleedings between groups (0% vs. 0.3%). CONCLUSIONS: The results of this multicenter registry show that the use of Cre8 AES in patients needing short DAPT (≤3-month) was safe regarding ischemic events and could favor a reduction of bleeding events related to the recommended DAPT. A large randomized trial is necessary to support these preliminary findings.

One-year clinical outcome of amphilimus polymer-free drug-eluting stent in diabetes mellitus patients: Insight from the ASTUTE registry (AmphilimuS iTalian mUlticenTre rEgistry).

BACKGROUND: Despite several improvements in drug-eluting stent (DES) technology, patients with diabetes mellitus (DM) are affected by higher rate of adverse events after PCI with DES, mainly in terms of target lesion revascularization (TLR). The Cre8 stent, a polymer-free amphilimus-eluting stent (AES), has shown promising preliminary results in DM patients. The ASTUTE registry was conceived to assess clinical performance of this polymer-free AES in DM in a "real-world" multicenter-independent cohort of patients. METHODS: 1216 consecutive patients (1637 lesions) treated with Cre8 between August 2011 and January 2015 were retrospectively enrolled and divided in two groups: DM and non-DM patients. The primary and secondary endpoints were target lesion failure (TLF) and TLR at 1-year, respectively. RESULTS: 1-Year clinical outcome was available for 407 (80%) DM and 566 (84%) non-DM patients. Diabetic patients were more frequently affected by hypertension (p<0.001) and dyslipidemia (p<0.001) and more frequently dialyzed (p=0.010). At 1-year, TLF occurred in 50 (5.1%) overall patients, and was similar in DM and non-DM patients (4.9 vs 5.3%, respectively, p=0.788). The secondary endpoint (TLR) occurred in 3% of overall patients and similarly in DM and non-DM patients (3.7 vs 2.5%, respectively, p=0.273). Primary and secondary endpoints were similar also between insulin and non-insulin dependent DM patients. CONCLUSIONS: The results of this large, real-world, multicenter-independent registry show that Cre8 AES has similar safety and efficacy profile in DM as well as non-DM patients, reducing the adverse outcomes related to DM in patients undergoing PCI. A large randomized trial will be necessary to definitely prove these preliminary findings.

Does optimal lesion preparation reduce the amount of acute recoil of the Absorbe BVS? Insights from a real-world population.

OBJECTIVES: To evaluate the acute recoil of the ABSORB bioabsorbable vascular scaffold (BVS) and its relationship with procedural characteristics in a real world population. BACKGROUND: In vivo acute recoil of the BVS was evaluated in selected patients. METHODS: Acute recoil was studied with videodensitometry in a consecutive series of patients treated by means of a BVS, and the results were compared with those obtained in subjects receiving an everolimus-eluting stent (EES). Recoil was defined as the difference between the mean diameter of the fully expanded balloon on which the device was mounted (or the mean diameter of the post-dilatation balloon), and the mean luminal diameter of the treated segment immediately after the final inflation. RESULTS: Recoil was assessed in 106 lesions treated with a BVS and 71 treated with an EES. The absolute and percent recoil of the BVS were significantly greater (0.32 ± 0.16 mm and 10% ± 5% vs. 0.17 ± 0.07 and 5% ± 3%; P < 0.001). Multiple regression analysis showed that BVS use was associated with acute recoil (ß = 0.477; P<0.001). Suboptimal lesion preparation (residual stenosis after balloon angioplasty >20%) (ß = 0.217; P = 0.027) and a small vessel reference diameter (ß = 0.335; P = 0.002) were associated with increased BVS but not EES recoil. CONCLUSIONS: In unselected patients, the acute recoil of the BVS was significantly greater than that of the metal EES. In the BVS group, residual stenosis after predilatation correlated with percent recoil, and so optimal lesion preparation seems to be mandatory in order to maximize the mechanical properties of the scaffold.

Stress cardiomyopathy and arrhythmic storm in a 14-year-old boy.

Stress cardiomyopathy is a newly described reversible cardiomyopathy, characterized by transient cardiac dysfunction usually precipitated by intense emotional or physical stress. Apart from the classical apical ballooning syndrome (Takotsubo), it is now increasingly recognized that the spectrum of stress cardiomyopathies is quite wide, with significant individual variations in clinical and morphological pattern. Very recently, it has been suggested that, in young boys in stressful situations, atypical forms of stress cardiomyopathy could be associated with malignant arrhythmias. We describe the case of a 14-year-old boy, in whom stress cardiomyopathy with mid-ventricular ballooning started with an arrhythmic storm.

Percutaneous closure of a giant coronary arteriovenous fistula using free embolization coils in an adult patient.

Coronary artery fistulae may sometimes be asymptomatic and may spontaneously close, but they may also cause angina, myocardial infarction, endocarditis, atrial fibrillation and heart failure. Therefore, in patients with big or symptomatic fistulae, intervention is mandatory. In the literature, most of the patients who underwent transcatheter coil embolization of coronary artery fistulae were children; this is because of the early onset of symptoms in the most severe cases, but also because many adult patients are usually referred to surgery. We describe the case of an adult patient presenting with heart failure and a giant tortuous coronary fistula, with high shunt flow from right coronary artery to right atrium, which was successfully treated with transcatheter closure with free embolization coils. The most challenging technical aspect of transcatheter coil embolization is the precise release of the spirals.

Usefulness of exercise myocardial scintigraphy in multivessel coronary disease after incomplete revascularization with coronary stenting.

The aim of this prospective study was to evaluate the prognostic value of exercise myocardial scintigraphy in patients who undergo incomplete revascularization with percutaneous coronary stenting. In 322 consecutive patients (mean age 61 +/- 10 years), exercise technetium-99m-tetrofosmin single-photon emission computed tomography scintigraphy was prospectively performed 4 to 6 months after an incomplete revascularization procedure. Follow-up lasted < or = 84 months (median 33). Patients with normal findings were at low risk of cardiac events compared with patients with mildly abnormal and severely abnormal findings (yearly event rate 1.5% vs 5.1% and 8.5%, respectively, p < 0.01). A significant difference was observed in hard, soft, and composite event-free survival among patients with normal, mildly abnormal, and severely abnormal findings (p < 0.01, p < 0.03, and p < 0.01, respectively). Nuclear data provided significant incremental prognostic value for cardiac events compared with the clinical, angiographic, and exercise test findings. In conclusion, in patients with incomplete revascularization procedures, exercise myocardial scintigraphy provides significant independent information concerning the subsequent risk of cardiac events, with an annualized event rate of < 2% for patients with normal scan findings. Myocardial scintigraphy is able to provide incremental prognostic information after adjusting for clinical, angiographic, and exercise variables.

First clinical experience with a paclitaxel derivate-eluting polymer stent system implantation for in-stent restenosis: immediate and long-term clinical and angiographic outcome.

BACKGROUND: It has been shown that antiproliferative drugs such as paclitaxel lower the amount of intimal hyperplasia after stent implantation. We report the first clinical experience of 7-hexanoyltaxol (QP2)-eluting polymer stent system (QuaDS) implantation for in-stent restenosis. METHODS AND RESULTS: Fifteen consecutive patients with elective indication to percutaneous coronary intervention for in-stent restenosis were treated with the QuaDS-QP2 stent implantation. The QuaDS-QP2 stent was successfully implanted in all but 2 target lesions. In one lesion, the restenotic segment could not be completely covered by the stent, and in another lesion, a bare metal stent was implanted distally to the QuaDS-QP2 stent. One patient suffered from postprocedural non-Q-wave myocardial infarction (NQWMI). No other adverse events were observed during hospital stay. Six- and 12-month angiographic and clinical follow-up was scheduled for all patients. At 6 months, 3 patients had target lesion revascularization (20%). Two patients had restenosis (13.3%); one experienced restenosis in a gap between 2 drug-eluting stents, and the other had stent occlusion leading to NQWMI. Minimal intimal hyperplasia was observed in all the segments covered by drug-eluting stents (late loss=0.47+/-1.01 mm with a loss index=0.17+/-0.39). At 12 months, 1 patient suffered from NQWMI, and 8 of 13 patients (61.5%) had angiographic restenosis (late loss=1.36+/-0.94 mm with a loss index=0.62+/-0.44). CONCLUSION: This first experience with QuaDS-QP2 stent implantation for in-stent restenosis revealed minimal intimal hyperplasia at the 6-month follow-up. However, the antiproliferative effect was not maintained at the 12-month follow-up, resulting in delayed occurrence of angiographic restenosis.