Vascular Access in Patients With Peripheral Arterial Disease Undergoing TAVR: The Hostile Registry.

BACKGROUND: The optimal access route in patients with severe peripheral artery disease (PAD) undergoing transcatheter aortic valve replacement (TAVR) remains undetermined. OBJECTIVES: This study sought to compare clinical outcomes with transfemoral access (TFA), transthoracic access (TTA), and nonthoracic transalternative access (TAA) in TAVR patients with severe PAD. METHODS: Patients with PAD and hostile femoral access (TFA impossible, or possible only after percutaneous treatment) undergoing TAVR at 28 international centers were included in this registry. The primary endpoint was the propensity-adjusted risk of 30-day major adverse events (MAE) defined as the composite of all-cause mortality, stroke/transient ischemic attack (TIA), or main access site-related Valve Academic Research Consortium 3 major vascular complications. Outcomes were also stratified according to the severity of PAD using a novel risk score (Hostile score). RESULTS: Among the 1,707 patients included in the registry, 518 (30.3%) underwent TAVR with TFA after percutaneous treatment, 642 (37.6%) with TTA, and 547 (32.0%) with TAA (mostly transaxillary). Compared with TTA, both TFA (adjusted HR: 0.58; 95% CI: 0.45-0.75) and TAA (adjusted HR: 0.60; 95% CI: 0.47-0.78) were associated with lower 30-day rates of MAE, driven by fewer access site-related complications. Composite risks at 1 year were also lower with TFA and TAA compared with TTA. TFA compared with TAA was associated with lower 1-year risk of stroke/TIA (adjusted HR: 0.49; 95% CI: 0.24-0.98), a finding confined to patients with low Hostile scores (Pinteraction = 0.049). CONCLUSIONS: Among patients with PAD undergoing TAVR, both TFA and TAA were associated with lower 30-day and 1-year rates of MAE compared with TTA, but 1-year stroke/TIA rates were higher with TAA compared with TFA.

"No-Reflow" Phenomenon: A Contemporary Review.

Primary percutaneous angioplasty (pPCI), represents the reperfusion strategy of choice for patients with STEMI according to current international guidelines of the European Society of Cardiology. Coronary no-reflow is characterized by angiographic evidence of slow or no anterograde epicardial flow, resulting in inadequate myocardial perfusion in the absence of evidence of mechanical vessel obstruction. No reflow (NR) is related to a functional and structural alteration of the coronary microcirculation and we can list four main pathophysiological mechanisms: distal atherothrombotic embolization, ischemic damage, reperfusion injury, and individual susceptibility to microvascular damage. This review will provide a contemporary overview of the pathogenesis, diagnosis, and treatment of NR.

CARotid plaqUe StabilizatiOn and regression with evolocumab: Rationale and design of the CARUSO study.

BACKGROUND: While the experience with PCSK9i in patients with coronary artery disease has been wide, and coronary plaque regression has been documented, little is known regarding the role of these drugs on carotid plaque regression. The CARotid plaqUe StabilizatiOn and regression with evolocumab (CARUSO) study is a randomized, single-center, investigator-initiated trial aiming at evaluating carotid plaque morphological stabilization and regression following, respectively, 6 and 12 months of therapy with evolocumab. METHODS: Asymptomatic patients with uni- or bilateral de novo carotid artery stenosis ≥50% and LDL-C values ≥100 mg/dl despite maximum tolerated lipid lowering therapy (LLT) will be randomized to evolocumab 140 mg s.c. every 2 weeks on top of ongoing LLT, or no additional treatment. 100 patients (50 in each arm) will be enrolled. Serial carotid duplex ultra-sonography will be performed to monitor the carotid plaque morphology and stenosis over time. RESULTS: The primary end point of the study is, (a) carotid plaque morphological stabilization at 6 months, defined as defined as the disappearance of ulcerations and fluffy components and the achievement of a regular plaque morphology with prevalence of fibrous atheroma and/or (b) carotid plaque regression at 12 months, defined as reduction of the entity of the stenosis and/or peak systolic velocity by at least 5%, as compared with baseline. CONCLUSION: The CARUSO trial will test the superiority of evolocumab on top of ongoing LLT versus ongoing LLT alone regarding carotid plaque morphological stabilization and regression. The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.

Morphological stabilization and regression of carotid plaque following therapy with evolocumab in a high-risk patient.

Lipid-lowering therapy is a mainstay for the management of coronary and carotid disease. Actually, progression of atherosclerosis and adverse events are reduced in proportion to the achieved levels of LDL cholesterol (LDL-C). A 67-year-old patient underwent two hospitalizations 6 months apart due to acute coronary syndromes. In the first, PCI with drug-eluting stents (DES) was performed to treat ulcerated stenoses in the left anterior descending artery. In the second, lipid-rich critical disease was found on the right coronary artery and treated with PCI + DES. Later, carotid duplex ultra-sonography (DU) was done due to some episodes of dizziness. It showed an 80% critical stenosis (peak systolic velocity, PSV 239 cm/s) of the left internal carotid artery (LICA) with high-risk features (hypoechogenic and irregular plaque with "fluffy" components). In consideration of the plaque morphology and the unmet LDL-C targets, evolocumab was added to the ongoing statin therapy. In the following months, we observed a parallel trend between carotid plaque regression and LDL-C lowering. Initial plaque remodeling was seen after 5 months: the atheroma appeared fibrotic, with no more fluffy components. At 10 months, in conjunction with the achievement of LDL-C goal (23 mg/dl), a fibrocalcific atheroma was observed; PSV, after an initial rise, fell to 229 cm/s. No further cardiovascular event occurred at 46 months. Last DUS showed a 60% fibrocalcific mid LICA stenosis with PSV of 180 cm/s. Our experience highlights the important role of proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors in promoting remodeling and hopefully regression of atherosclerotic plaques.

True caring is protecting who is at your side.

The modified jailed balloon technique (MJBT) is a safe and effective tool for preserving immediate and long-term side branch (SB) patency when treating true bifurcation lesions. This technique could be routinely implemented, or selectively chosen when the risk of SB occlusion is high and a two-stent technique is not desirable. A randomized study comparing provisional stenting with the MJBT versus systematic two-stent strategy for the treatment of true bifurcation lesions is warranted.

The first love, you never forget. The last heart valve, you might remember better than the first.

Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) does not increase cerebrovascular risk compared with TAVR in native aortic valves; the only predictors of new brain lesions were age and postdilatation. Wise choice of the biological valve at the time of surgical aortic replacement, routine use of cerebral protection devices, and new therapeutic paths may be important. Larger studies are needed, hopefully with systematic postdilatation or bioprosthetic valve fracture in cases of residual high transvalvular gradients after VIV TAVR.

Choose to fly higher rather than pacing around.

Pre-existing right bundle branch block and the depth of the prosthesis in the left ventricle are predictors of permanent pacemaker implantation (PPI) following transcatheter aortic valve replacement. The recapturable capability of the Evolut R system allows higher and more precise valve implantation and this was associated with halved incidence of PPI as compared with the CoreValve. Larger studies are needed to assess the feasibility of systematic very high implantation (depth in the left ventricle outflow tract ≤3 mm) of the Evolut R and the associated rate of PPI.

One, two, three breakdance and twist.

Wire breakage during percutaneous coronary intervention is a rare event. It occurs especially when treating complex lesions, and it should be prevented with careful planning of each procedural step. We reported a case in which wire breakage occurred when treating the left anterior descending (LAD)/first diagonal bifurcation with the T-stenting technique. After careful evaluation of all the available retrieval techniques and failure of the balloon-catheter trapping, the twin-twisting wires technique (TTWT) was applied. This technique allows the retrieval of a foreign body thanks to its entrapment in the spiral made by two twisting wires. At the first attempt, the broken wire was only withdrawn and not retrieved, while the two twisting wires went broken. The second attempt was performed using stronger wires as twisting wires. The two recently broken fragments were successfully retrieved together with a long proximal remnant of the initially broken wire, which distal tip was further withdrawn. The broken wire was successfully retrieved with the third attempt, together with the previously implanted LAD stent that was accidentally entrapped in the twist. This is the first report of TTWT implementation for the retrieval of a broken wire from a two-stent bifurcation, both proximal and distal wire remnants and a total of three broken wires. The improvements we made to the technique, tips and tricks, caveats, and suggestions for successful wire retrieval and avoidance of the complications that we experienced are described in detail.

[Cognitive and quality of life trajectory after either surgical or transcatheter aortic valve replacement in high-risk patients]. / Evoluzione dello stato cognitivo e della qualità di vita in pazienti con stenosi aortica ad alto rischio clinico sottoposti a sostituzione valvolare chirurgica o per via transcatetere.

RATIONALE: The impact of transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (AVR) on cognitive status and quality of life in high-risk patients has been incompletely investigated. METHODS: We conducted a prospective, multicenter study including all patients treated with TAVI and high-risk patients undergoing AVR (age ≥80 years or logistic EuroSCORE ≥15%) at participating centers. Multidimensional geriatric evaluation including Mini Mental State Examination (MMSE), EuroQol 5D (EQ5D) and Minnesota Living With Heart Failure Questionnaire (MLHFQ) were performed at baseline and at 3- and 12-month follow-up. RESULTS: A total of 518 patients (151 AVR and 367 TAVI) were enrolled in 10 Italian institutions. Patients receiving AVR were older (82.7 ± 2.4 years), with a lower logistic EuroSCORE (12.5 ± 7.1%) as compared with TAVI patients (81.5 ± 6.2 years and 19.6 ± 14.0%, respectively, p=0.001 and p<0.001). Overall, 35.5% of patients showed some degree of cognitive impairment at baseline, with no differences between groups. No significant changes in the cognitive status were observed between baseline and follow-up and between groups at any time point. TAVI patients had a lower quality of life at baseline as compared with AVR patients. Generic and heart failure-related quality of life improved significantly after either procedure. CONCLUSIONS: In high-risk patients, both TAVI and AVR are associated with a significant improvement of quality of life up to 1 year without a detrimental effect on cognitive function.

[Transcatheter aortic valve implantation versus aortic valve replacement: cost analysis from the regional health service and hospital perspectives]. / I costi di ricovero e follow-up delle procedure di sostituzione valvolare aortica per via percutanea e cardiochirurgica a confronto: analisi secondo le prospettive del Sistema Sanitario Regionale e dell'Ospedale.

BACKGROUND: The aim of this study was to estimate the cost of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (AVR) procedures, together with the cost of the first-year hospitalizations following the index ones, in 4 Italian regions where diffusion level of TAVI and coverage decisions are different. METHODS: The cost analysis was performed evaluating 372 patients enrolled consecutively from December 1, 2012 to September 30, 2015. The index hospitalization cost was calculated both from the hospital perspective through a full-costing approach and from the regional healthcare service perspective by applying the regional reimbursement tariffs. The follow-up costs were calculated for one year after the index hospitalization, from the regional healthcare sservice perspective, through the identification of hospital admissions for cardiovascular pathologies after the index hospitalization and computation of the relative regional tariffs. RESULTS: The mean hospitalization cost was € 32 120 for transfemoral TAVI (232 procedures), € 35 958 for transapical TAVI (31 procedures) and € 17 441 for AVR (109 procedures). From the regional healthcare service perspective, the mean transfemoral TAVI cost was € 29 989, with relevant regional variability (range from € 19 987 to € 36 979); the mean transapical TAVI cost was € 39 148; the mean AVR cost was € 32 020. The mean follow-up costs were € 2294 for transfemoral TAVI, € 2335 for transapical TAVI, and € 2601 for AVR. CONCLUSIONS: In our study, transapical TAVI resulted more expensive than transfemoral TAVI, while surgical AVR was cheaper than both (less than 40%). Costs of the transfemoral approach showed great variability between participating regions, probably due to different hospital costs, logistics, patients' selection and reimbursement policy. A central level of control would be appropriate to avoid unjustified differences in access to innovative procedures between different Italian regions.

[Quality of life after transcatheter aortic valve implantation: a Comprehensive literature review and critical appraisal]. / La qualità di vita dopo impianto transcatetere di valvola aortica: revisione e valutazione critica della letteratura.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a very effective treatment option for patients with severe aortic stenosis who are either not suitable candidates or at high risk for surgical aortic valve replacement (AVR). Patients undergoing TAVI are often very elderly and their clinical status is burdened with multiple comorbidities, therefore evaluation of quality of life (QoL) might be challenging. We sought to provide an overview of available data on QoL changes after TAVI and critical insights on the instruments used to detect these changes. METHODS: This analysis focuses on studies that evaluated QoL after TAVI with standardized questionnaires. Out of 706 items identified through literature search, 23 studies were included in the final review: 2 randomized controlled trials (one comparing QoL pre- vs post-TAVI, one TAVI vs AVR vs medical therapy) and 21 observational studies (19 studies comparing QoL pre- and post-TAVI and 2 studies TAVI vs AVR). The instruments used in all studies were not specific for TAVI patients. RESULTS: Most studies reported a significant improvement in QoL after TAVI, greater for physical aspects compared with psychological components, which persisted at mid and long-term follow-up. A short-term benefit was found for transfemoral TAVI patients as compared with transapical TAVI and AVR; however, these differences tended to disappear over time. CONCLUSIONS: The study highlights an improvement in QoL after TAVI that persists over time. As different instruments resulted to be more sensitive to detect different aspects, multidimensional assessments - capable of combining disease-specific and disease-non-specific measures - should foster clinical research in order to have a more complete picture of QoL of TAVI patients.

Stent implantation in patients with severe left ventricular systolic dysfunction.

BACKGROUND: Patients with ischemic severe left ventricular (LV) dysfunction are at higher risk for death. We assessed the outcome following percutaneous coronary intervention (PCI) in patients with LV systolic dysfunction. METHODS: From April 1993 to March 2004 337 consecutive patients with LV ejection fraction (LVEF)

Use of the Venture wire control catheter to access complex coronary lesions: how to turn procedural failure into success.

AIMS: To describe the impact of a steerable device on procedural success and times. The Venture wire control catheter (VWC-St. Jude Medical, Maple Grove, MN, U.S.A.), facilitates wire orientation providing excellent backup support and may therefore assist in cases in which conventional approaches have failed. METHODS AND RESULTS: We describe all cases in which the VWC catheter was used at our institutions. The device was employed after prolonged attempts with standard wires had failed. We analysed procedural success and complication rates, as well as the impact of this device on procedural times. We evaluated 18 cases. The mean time from the first wire attempt to the end of the procedure was 58 minutes. Lesion crossing attempts with standard wires were performed for a mean time of 23 minutes (range 10-45 minutes). The VWC catheter was employed as the last resort, leading to procedural success in 14 cases. Lesion crossing with the VWC catheter was achieved in a mean time of four minutes (range one to 15 minutes). There were no device-related complications. CONCLUSIONS: Our experience shows how the VWC catheter can turn procedural failures into successes, significantly impacting procedural times in different challenging scenarios. This device may represent an extremely useful addition to the interventionalist's armamentarium.

Percutaneous treatment of periprosthetic mitral valve leaks: is it just a futile exercise?

We report the percutaneous exclusion of a mitral peri-prosthetic valvular leak performed with the Amplatzer vascular plug. Device dislodgement occurred a few days later and surgical repair was ultimately required.