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An 87-year-old man with a history of transcatheter aortic valve replacement with a 6-year-old 27-mm Direct Flow bioprosthesis (Direct Flow Medical, Santa Rosa, California), presented with heart failure. Echocardiography showed normal transcatheter heart valve (THV) leaflets with no obstruction (mean

Objectives This study sought to evaluate the feasibility of complete cerebral protection during transcatheter aortic valve replacement (TAVR) with a novel embolic protection device. Background Evidences and data about new cerebral embolic protection devices are lacking and scarce. Methods A prospective, nonrandomized, multicenter, first-in-man pilot study designed to evaluate the efficacy and safety of cerebral embolic protection utilizing the Emblok embolic protection system (Innovative Cardiovascular Solutions, Grand Rapids, Michigan) during TAVR. The Emblok is a transfemoral aortic filter that provide full coverage of the epiaortic vessels. Brain diffusion-weighted magnetic resonance imaging (DW-MRI) was performed at baseline and 2 to 5 days after TAVR. Primary endpoints were technical success and immediate cerebral embolic burden after TAVR, defined as number and volume of new brain lesions detected with DW-MRI at days 2 to 5 post-TAVR compared with baseline. Results A total of 20 subjects were enrolled. The Emblok system was successfully positioned in all the cases. At 30-day follow-up, no major adverse cardiovascular and cerebrovascular events occurred. Nineteen (95%) patients had new ischemic defects at post-procedural DW-MRI. The median number of new lesions per patient was 10.00 (interquartile range [IQR]: 4.75 to 15.25). The total new lesion volume was 199.9 mm3 (IQR: 83.9 to 447.5 mm3) and the mean lesion volume per lesion was 42.5 mm3 (IQR: 21.5 to 75.6 mm3). Histopathologic analysis showed evidence of significant debris in 18 (90%) filters. Conclusions The Emblok embolic protection system appears to be feasible and safe during TAVR. The device was successfully placed and retrieved in all cases and no neurological events were observed. Cerebral total new lesion volume was similar to other trials on cerebral protection during TAVR, thus warranting a larger study. (European Study Evaluating the Emblok Embolic Protection System During TAVR; NCT03130491)

A 46-year-old woman underwent percutaneous patent foramen ovale closure at another institution for recurrent cerebral transient ischemic attacks in the context of hereditary thrombophilia. Because anatomy was considered appropriate, the novel suture-based “deviceless” NobleStitch EL (Kardia

Background: The ULISSE registry has demonstrated the real-world performance of the Ultimaster biodegradable polymer sirolimus-eluting stent (BP-SES) in a large cohort of patients undergoing percutaneous coronary intervention, including a large proportion of patients presenting with acute myocardial infarction (AMI). Methods: We performed a subgroup analysis of the ULISSE registry in AMI patients and compared the outcomes of this vulnerable cohort with that of patients presenting without AMI (non-AMI). The primary end point was the incidence of 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (TLR). Results: Of 1,660 patients included in the ULISSE registry, 381(23%) presented with AMI, 207(54.3%) non-ST elevation myocardial infarction, and 174(45.7%) ST-elevation myocardial infarction. Compared with non-AMI patients, those with AMI were more frequently female and smokers, with lower left ventricular ejection fraction (LVEF) and chronic kidney disease requiring dialysis. At 1 year, TLF rate was significantly higher in AMI than non-AMI patients (7.9 vs. 4.1%; HR 1.98, CI 95% 1.22–3.23; p =.005) driven by higher rate of cardiac death (4.0 vs. 1.1%; HR 3.59, CI 95% 1.64–7.88; p =.01) and TV-MI (2.8 vs 0.9%; HR 2.99,CI 95% 1.22–7.37; p =.01), without differences in TLR rate (4.3 vs. 2.9%,HR 0.66, CI95% 0.35–1.25; p =.2). At multivariate Cox regression analysis, eGFR

Aim The aim of this study is to describe our 9-year experience in transcatheter aortic valve replacement (TAVR) using transthoracic echocardiography (TTE) as a routine intra-procedural imaging modality with trans-oesophageal echocardiography (TEE) as a backup. Methods and results From January 2008 to December 2017, 1218 patients underwent transfemoral TAVR at our Institution. Except the first 20 cases, all procedures have been performed under conscious sedation, with fluoroscopic guidance and TTE imaging monitoring. Once the TTE resulted suboptimal for final result assessment or a complication was either suspected or identified on TTE, TEE evaluation was promptly performed under general anaesthesia. Only 24 (1.9%) cases required a switch to TEE: 6 cases for suboptimal TTE prosthetic valve leak (PVL) quantification; 12 cases for haemodynamic instability; 2 cases for pericardial effusion without haemodynamic instability; 4 cases for urgent TAVR. The 30-days and 1-year all-cause mortality were 2.1% and 10.2%, respectively. Cardiac mortality at 30-days and 1-year follow-up were 0.6% and 4.1%, respectively. Intra-procedural and pre-discharge TT evaluation showed good agreement for PVL quantification (k agreement: 0.827, P = 0.005). Conclusion TTE monitoring seems a reasonable imaging tool for TAVR intra-procedural monitoring without delay in diagnosis of complications and a reliable paravalvular leak assessment. However, TEE is undoubtedly essential in identifying the exact mechanism in most of the complications.

Background: Moderate or severe paravalvular leak (PVL >= moderate) after transcatheter aortic valve implantation (TAVI) is associated with poor outcomes. The aim of this study was to assess whether the baseline ejection fraction (EF) affects the impact of PVL on mortality after TAVI. Methods: We analyzed 514 consecutive patients with native severe aortic stenosis who underwent TAVI. Patients were divided into two groups: EF = 40% group (n = 430) according to baseline EF. Results: The mean age was 79.5 years and 49% were male. Patients in the EF = 40% group. Diabetes, coronary artery disease, atrial fibrillation and renal insufficiency were more prevalent in the EF = moderate was significantly associated with increased 2-year estimated mortality only in the EF = 40% group (24% vs. 19%, log-rank p = 0.509). Interaction between PVL >= moderate and EF = moderate on mortality after TAVI was significant in the EF = 40% group in our study. Even though operators should aim to minimize PVL in all TAVI patients, special attention is required for patients with reduced baseline EF. (C) 2015 Elsevier Ireland Ltd. All rights reserved. OI Giustino, Gennaro/0000-0002-5400-9516

Recurrent mitral regurgitation (MR) may occur after mitral annuloplasty and reoperation may be associated with significant morbidity and mortality. Recently, transcatheter mitral valve-in-ring procedures via the transvenous, transatrial, and transapical routes have been shown to be a feasible

Aims: The aim of this study was to report the feasibility and the preliminary outcomes after transcatheter aortic valve implantation (TAVI) in the frail and unique high-risk population of patients with systemic sclerosis (SSc) and severe aortic stenosis (AS). Methods and results: All patients with SSc and severe AS treated with TAVI between November 2007 and June 2013 in our centre were included in the current study. Outcomes were assessed using the Valve Academic Research Consortium 2 (VARC-2) definitions. Of 526 surgical high-risk patients treated in the study period, only six had SSc (1.1%). All SSc patients underwent transfemoral TAVI under conscious sedation. The procedure was successfully performed in all patients. There was one case of a major vascular complication. During a median follow-up time of 550 days (interquartile range 390-1,009 days), five of the six patients were alive, free from any complications and with an NYHA Class I or II. One patient died at 670 days from a stroke of unknown aetiology. Conclusions: The present case series suggests that the TAVI procedure is feasible in patients with SSc and severe AS. OI Giustino, Gennaro/0000-0002-5400-9516

BackgroundPost-procedural aortic regurgitation (AR) negatively impacts the prognosis after trans-catheter aortic valve implantation. However, data evaluating the impact of different post-procedural AR grades (particularly mild) on clinical outcomes are still important.Aim and MethodsA retrospective cohort analysis was performed on all consecutive patients with severe aortic stenosis who underwent trans-catheter aortic valve implantation between July 2008 and August 2011 in a single Institution. Aim of the study was to evaluate the impact of different post-procedural AR grades on early and mid-term clinical outcomes.Results322 consecutive patients were evaluated. At post-procedural echocardiographic evaluation: 105 (32.6%) patients had no AR, 204 (63.4%) mild AR and 13 (4%) moderate/severe AR. In-hospital mortality was higher in patients with moderate/severe AR than in those with absent or mild AR (38.5% vs. 2.6%, P

A 52-year-old man underwent surgical mitral repair for P2 flail. A conventional Carpentier technique was used (quadrangular resection+sliding plasty and annuloplasty with a 35-mm flexible band). Predischarge echocardiography showed no residual MR and no systolic anterior motion (SAM). One year after surgery, the patient came to our attention complaining dyspnoea on effort (New York Heart Association III). Rest echocardiography showed absence of recurrent MR, but evidence of SAM with mild left ventricular outflow tract (LVOT) obstruction. Exercise echocardiography revealed a significant SAM with severe LVOT obstruction (Figure 1; Movies I–III in the Data Supplement). An induced pressure gradient of 144 mm Hg and a dynamic flow acceleration with late systolic peak velocity were observed across the LVOT with concomitant moderate MR and mild pulmonary hypertension (systolic pulmonary pressure, 40 mm Hg; Figure 1). A pharmacological approach was attempted first (atenolol, 100 mg QID; diltiazem 180 mg QID) without clinical improvements and changes in SAM and LVOT obstruction. Therefore, an interventional strategy was considered. A MitraClip procedure was planned to correct the SAM. Adrenaline infusion was used to induce SAM. After ineffective attempts to place the clip in the central …

Conduction disorders and permanent pacemaker implantation are common complications in patients who undergo transcatheter aortic valve implantation (TAVI). The aim of this study was to assess the incidence and clinical significance of new bundle branch block in patients who underwent TAVI with the Medtronic CoreValve Revalving System (MCRS) or the Edwards SAPIEN valve (ESV). Data from 238 patients with no previous pacemaker implantation, left bundle branch block (LBBB) or right bundle branch block at baseline electrocardiography who underwent TAVI with either MCRS (n = 87) or ESV (n = 151) bioprostheses from 2007 to 2011 were analyzed. New-onset LBBB occurred in 26.5% patients (n = 63): 13.5% with the ESV (n = 20) and 50.0% with the MCRS (n = 43) (p = 0.001). Permanent pacemaker implantation was required in 12.7% of patients (n = 8) because of complete atrioventricular block (ESV n = 2, MCRS n = 4), LBBB and first degree atrioventricular block (MCRS n = 1) and new-onset LBBB associated with sinus bradycardia (MCRS n = 1). At discharge, LBBB persisted in 8.6% of ESV patients (n = 13) and 32.2% of MCRS patients (n = 28) (p = 0.001). On multivariate analysis, the only predictor of LBBB was MCRS use (odds ratio 7.2, 95% confidence interval 2.9 to 17.4, p

A 74-year-old man was referred for worsening symptoms of left-sided heart failure (New York Heart Association functional class III) 1 year after undergoing an edge-to-edge repair with 2 MitraClips (Abbott Vascular, Santa Clara, California) for functional mitral regurgitation (FMR) at another

Post-operative hyperglycemia, in individuals with and without diabetes, has been identified as a predictor of acute kidney injury (AKI) in patients following cardiac surgery. Whether or not this is also true for patients undergoing transcatheter aortic valve implantation (TAVI) is unknown.To evaluate whether post-procedural glucose levels are associated with AKI after TAVI.A total of 422 consecutive patients undergoing transfemoral TAVI were included in the analysis. For each patient, plasma glucose levels were assessed at hospital admission, 4h after the procedure and daily during hospitalization. Post-procedural hyperglycemia was defined as 2 consecutive blood glucose readings ≥150mg/dL in the 72-hour period following TAVI. AKI was defined according to the VARC consensus report regarding standardized endpoint definitions. Overall, 137 (32.5%) patients developed post-procedural hyperglycemia and 138 (33%) patients developed AKI. Hyperglycemia was associated with a 2-fold higher incidence of AKI than in patients without hyperglycemia (48% vs. 25%, p0.001). In-hospital mortality was higher in patients with hyperglycemia than in those without hyperglycemia (9.6% vs. 1.8%, p0.001). In-hospital mortality rate was also higher in patients who developed AKI (12.7% vs. 2.7%, p0.001). Patients with acute hyperglycemia that developed AKI had the highest in-hospital and long-term mortality rate (15% and 38%). Post-procedural hyperglycemia was an independent predictor of AKI.Post-procedural hyperglycemia is associated with a higher incidence of AKI and mortality after TAVI. Randomized controlled trials are needed to determine whether meticulous post-procedural glycemic control following TAVI impacts upon clinical outcomes.

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.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.1-Year clinical outcome was available for 407 (80%) DM and 566 (84%) non-DM patients. Diabetic patients were more frequently affected by hypertension (p0.001) and dyslipidemia (p0.001) 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.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.

Aims Reoperation for bioprosthetic heart valve failure is associated with significant morbidity and mortality, particularly in high-risk patients. Transcatheter valve-in-valve (VIV) implantation may offer a less invasive alternative. The aim of this study was to report our initial experience with transcatheter VIV implantation to treat degenerated tissue valves. Methods and results VIV implantation with the Edwards SAPIEN transcatheter heart valve (THV; Edwards Lifesciences Inc, Irvine, CA, USA) was performed in 18 high-risk patients (STS 8.2±5.2%; logistic EuroSCORE 37.4±20.8%) with symptomatic bioprosthetic failure (17 aortic, one mitral). Valve Academic Research Consortium (VARC) definitions were applied for endpoint adjudication. Transfemoral access was the preferred vascular approach (16 patients, with the mitral VIV delivered anterogradely through the femoral vein; one transaxillary and one transapical). The majority (83%) of procedures were performed under local anaesthesia and sedation. Device success was achieved in all but one patient who had a final transaortic gradient ≥20mmHg. Acute kidney injury occurred in three patients (Stage 3 in 1), life-threatening or major bleeding in four patients, while major vascular complications occurred in one patient. Permanent pacemaker implantation was required in two patients. There were no deaths or neurological events at 30-day follow-up. At a median follow-up of 11 months (interquartile range 6-16), the mortality rate was 5.6% and all patients were in NYHA class II or lower. Conclusions Transcatheter implantation of the Edwards THV within a degenerated aortic bioprosthesis, performed predominantly via the transfemoral route, is feasible and associated with good periprocedural and clinical outcomes in high-risk surgical patients.

Objectives The aim of this study was to analyze the short-term outcomes after transcatheter aortic valve implantation with the Edwards Sapien THV (ESV), compared with the Sapien XT THV (SXT) (Edwards Lifesciences, Irvine, California). Background The SXT has been recently commercialized in Europe, but there are no studies analyzing the efficacy and safety of SXT, compared with ESV. Methods All consecutive patients (n = 120) who underwent transcatheter aortic valve implantation in our center via the transfemoral approach with either ESV (n = 66) or SXT (n = 54). Valve Academic Research Consortium endpoints were used. Results Mean age was 80 ± 8 years, and mean Logistic-European System for Cardiac Operative Risk Evaluation was 24.9 ± 17.0. The ilio-femoral artery minimal lumen diameter was smaller in patients treated with the SXT (7.27 ± 1.09 mm vs. 7.94 ± 1.08 mm, p = 0.002). Device success was high in both groups (96.3% vs. 92.4%, p = 0.45). Major vascular events were 3-fold lower in the SXT group (11.1% vs. 33.3%, relative risk: 0.40, 95% confidence interval: 0.28 to 0.57; p = 0.004). Life-threatening and major bleeding events were not significantly different between groups (18.5% vs. 27.3% and 35.2% vs. 40.9%, respectively). The SXT group had a lower 30-day Valve Academic Research Consortium combined safety endpoint (20.4% vs. 45.5%; relative risk: 0.44, 95% confidence interval: 0.24 to 0.80; p = 0.004). The 30-day mortality was 1.7% (n = 2). At 30 days, mean transaortic gradient was approximately 10 mm Hg in both groups and the aortic regurgitation was mild-to-moderate in 70.2% of SXT and 76.3% of ESV. Conclusions The new SXT valve has the same short-term performance as the ESV but seems to be associated with a lower risk of major vascular complications and thus has a broader clinical application.

Objectives: To describe results from a novel percutaneous technique designed to minimize the risk of hemorrhage in the event of a major complication during transcatheter aortic valve implantation. Background: Vascular access management is a major challenge in transfemoral TAVI due to the large introducer sheathes required. Methods: Fifty-two pts underwent TAVI between November 2007 and March 2009. Of these, 37 received an Edwards-Sapien Valve (23 mm valve: 17/37; 26 mm valve: 20/37) whilst 15 patients received a CoreValve (26 mm valve: 6/15; 29 mm valve: 9/15). Using a crossover technique, the opposing femoral artery was cannulated with a 7Fr long sheath. This allowed contralateral passage of a balloon and inflation in the proximal iliac. The sheath was then removed and Prostar sutures tied in a dry field. Balloon optimization of the puncture site was performed as required. Results: In three subjects, elective surgical repair was undertaken due to excessive femoral arterial calcification. In the remaining 49, the crossover technique was employed and closed with two Prostar devices (Edwards-Sapien) or one (CoreValve). There were serious “on-table” complications in seven patients, six due to the large introducer sheathes used in the TAVI procedure—iliac avulsion, two iliac dissections, iliac perforation, common femoral perforation and scrotal hematoma. All were repaired safely by combined surgical and endovascular techniques, using the crossover technique to ensure patient stability. All made a good recovery and were independently ambulant at discharge. Conclusion: Using crossover balloon inflation as an adjunct to Prostar closure may be helpful for managing TAVI vascular access sites. © 2009 Wiley-Liss, Inc.

Suprarenal fixation by means of proximal bare stent may help prevent endograft migration and proximal endoleak. It seems not to compromise renal perfusion and function; however, it is still unclear whether its presence is in conflict with stenting of the renal arteries to treat associated renal stenosis. We report five cases of renal artery stenting performed before, at the same time, or after endovascular treatment of abdominal aortic aneurysm with a suprarenal fixation endograft (Zenith; Cook, Biaverskov, Denmark). Suprarenal fixation endograft seems to not affect renal artery stenting regardless the timing of the procedure. Suprarenal fixation by means of proximal bare stent may help prevent endograft migration and proximal endoleak. It seems not to compromise renal perfusion and function; however, it is still unclear whether its presence is in conflict with stenting of the renal arteries to treat associated renal stenosis. We report five cases of renal artery stenting performed before, at the same time, or after endovascular treatment of abdominal aortic aneurysm with a suprarenal fixation endograft (Zenith; Cook, Biaverskov, Denmark). Suprarenal fixation endograft seems to not affect renal artery stenting regardless the timing of the procedure.

An 80-year-old man affected by symptomatic (New York Heart Association III) aortic stenosis was referred to our center. Transthoracic echocardiogram showed low-flow low-gradient aortic stenosis (mean gradient 30 mm Hg, valve area 0.6 cm2, ejection fraction 35%). His past medical history included liver cirrhosis in chronic hepatitis C infection (Child-Pugh A6) and severe osteoporosis with chest deformation and restrictive pulmonary disease. His EuroSCORE was 15.4% and Society of Thoracic Surgeons score was 4.8%. Preoperative computed tomography revealed significant tortuosity of the descending thoracic aorta, with a double curve (Figure 1A–1C; Movie I in the Data Supplement) and a narrowest lumen diameter of 18 mm. Significant kinking was also present at the level of the right femoro-iliac axis (Figure 1B) with a minimum diameter was 9.1 mm at both sides. His aortic annulus size was calculated at 25×27 mm (area 540 mm2). After Heart Team discussion, in view of his multiple comorbidites, he was submitted to transcathter aortic valve implantation. Transfemoral route was deemed the most suitable access route because of the presence of restrictive pulmonary disease and increased associated risk with …

Today, increasing numbers of patients are presenting to clinical teams with signs and symptoms of mitral bioprosthesis failure. Whilst redo surgery is currently the treatment option of choice, many patients have multiple co-morbidities and are deemed to be of prohibitively high surgical and anaesthetic risk. Percutaneous transcatheter treatment can offer a potential solution for these patients. Herein is reported a case where simultaneous transcatheter interventions for paraprosthetic leak and mitral bioprosthesis implantation were performed via the transfemoral route, and an unforeseen complication was successfully managed.

Background— Coronary artery disease (CAD) screening is required before transcatheter aortic valve implantation (TAVR). Although invasive coronary angiography (CA) remains the gold standard for CAD assessment, computed tomographic CA (CTCA) could be a safe and effective noninvasive alternative for CAD screening in patients undergoing TAVR. Methods and Results— From November 2007 to May 2013, all patients undergoing TAVR at our institution were included in the study cohort. CTCA was used as first-line imaging tool for CAD screening. Invasive CA was performed when any of the following were present: coronary anatomy at CTCA was not evaluable and presence of significant CAD at CTCA. The primary objective was to compare major adverse cardiovascular and cerebrovascular events at 30 days and 1 year between patients who performed CTCA as only screening test and those who performed CTCA and invasive CA. Of 491 patients treated with TAVR, 375 (76.3%) performed only CTCA, whereas 116 (21.7%) underwent also CA. No differences were present in crude major adverse cardiovascular and cerebrovascular event rates at 30 days and 1 year between the 2 groups. After multivariable adjustment, CTCA performed alone was not associated with higher risk of MACE at 1 year of follow-up (hazard ratio, 0.89; 95% confidence interval, 0.49–1.60; P =0.69). Conclusions— CTCA performed as a routine noninvasive imaging tool in patients undergoing TAVR seems safe and effective allowing, with a single test, acquisition of information on aortic annulus anatomy, peripheral access sites, and evaluation of coronary anatomy.

Objectives The aim of this study was to assess the feasibility, safety and short-term outcomes of transfemoral transcatheter aortic valve implantation (TF-TAVI) in patients with small diseased peripheral vessels. Background The transfemoral (TF) route for transcatheter aortic valve (TAVI) is the default option due to associated advantages. However, this is limited due to the high prevalence of significant peripheral arterial disease and increased risk of vascular complications. Methods Of 539 consecutive patients undergoing TAVI in a single Italian center, 23 patients underwent TF-TAVI in the presence of small peripheral vessels as defined by a minimal luminal diameter (MLD) of ≤5.5mm [by computed tomography (CT)] and/or the inability to advance a large-bore sheath. Calcification was defined as being concentric if calcium extended more than 270° around the circumference of the artery. All patients underwent 30-day clinical follow-up. Results 17 (73.9%) patients underwent peripheral vessel pre-dilatation with a semi-compliant balloon and 6 (26.1%) patients with a Solopath sheath. 6 (26.1%) patients suffered a peri-procedural complication, with 1 patient requiring surgical embolectomy for thrombotic occlusion and the remaining patients successfully managed percutaneously in the catheter laboratory. No patient suffered a vessel perforation or required implantation of a covered stent. At 30-day follow-up, all patients were free of symptoms and signs or symptoms of peripheral vascular disease, with well-functioning TAVI prostheses as evaluated by echocardiography. Conclusions Performing TF-TAVI is feasible in patients with no other viable vascular access option in the presence of small MLD and calcification of the peripheral vasculature, with any anticipated acute vascular complication managed in the catheter laboratory with established percutaneous techniques.

Restenosis rate is lower after sirolimus-eluting stent (SES) implantation than after bare metal stent (BS) implantation. We evaluated the impact of SES implantation on immediate and 12-month outcome in diabetic patients with multivessel coronary artery disease (MVD). METHODS: From April 2002 to September 2003, 100 consecutive diabetic patients with MVD without previous myocardial revascularization underwent successful elective percutaneous coronary intervention (PCI) with SES on native coronary arteries at our institutions. A group (n = 122) of consecutive diabetic patients with MVD treated with BS implantation (BS group) for de novo lesions was selected from our database and matched with the SES group. Major adverse cardiac events (MACEs) during hospital stay and at follow-up included nonfatal myocardial infarction, death, bypass surgery, and re-PCI. RESULTS: At 12 +/- 4 months, MACEs occurred in 25% of patients in the SES group and in 44% of those in the BS group (P = .003, OR .72, 95% CI 0.57-0.91). Need for repeat intervention (re-PCI or bypass surgery) occurred in 17% of patients in the SES group and in 41% of those in the BS group (P < .001, OR .67, 95% CI 0.52-0.86). No significant difference in the rate of death and myocardial infarction was observed. In the SES group, the independent predictors of MACEs at follow-up were premature clopidogrel discontinuation (hazard ratio 20.62, 95% CI 1.60-264.97, P = .020) and chronic renal insufficiency (hazard ratio 4.73, 95% CI 1.99-11.25, P = .0004). CONCLUSIONS: As compared with BS implantation, SES implantation favorably influences outcome in diabetic patients with MVD, mainly by reducing the need for new revascularization.

To the Editor: Heyde's syndrome is the association between calcific aortic stenosis and gastrointestinal bleeding (GIB) due to angiodysplasia. This rare relationship is observed in approximately 3% of patients with aortic stenosis, and it was first suggested by Edward J. Heyde in 1958 ([1][1]). The

Objectives Paravalvular leaks (PVL) occur in up to 17% of all surgically implanted prosthetic valves. Re-operation is associated with high morbidity and mortality. Transcatheter closure via a surgical transapical approach(TAp) is an emerging alternative for selected high-risk patients with PVL. The aim of this study was to compare the in-hospital outcomes of patients who underwent surgery and TA-closure for PVL in our single-centre experience. Methods From October 2000 to June 2013, 139 patients with PVL were treated in our Institution. All the TA procedures were performed under general anaesthesia in a hybrid operative room: in all but one case an Amplatzer Vascular Plug III device was utilized. Results Hundred and thirty-nine patients with PVL were treated: 122 patients (87.3%) underwent surgical treatment (68% mitral PVL; 32% aortic PVL) and 17 patients (12.2%) underwent a transcatheter closure via a surgical TAp approach (all the patients had mitral PVL; one case had combined mitral and aortic PVLs); in 35% of surgical patients and in 47% of TAp patients, multiple PVLs were present. The mean age was 62.5 +/- 11 years; the Logistic EuroScore was 15.4 +/- 3. Most of the patients were in New York Heart Association (NYHA) functional class III-IV (57%). Symptomatic haemolysis was present in 35% of the patients, and it was particularly frequent in the TAp (70%). Many patients had > 1 previous cardiac operation (46% overall and 82% of TAp patients were at their second of re-operation). Acute procedural success was 98%. In-hospital mortality was 9.3%; no in-hospital deaths occurred in patients treated through a TAp approach. All the patients had less than moderate residual valve regurgitation after the procedure. Surgical treatment was identified as a risk factor for in-hospital death at univariate analysis (OR: 8,95% CI: 1.8-13; P = 0.05). Overall actuarial survival at follow-up was 39.8 +/- 7% at 12 years and it was reduced in patients who had > 1 cardiac re-operation (42 +/- 8 vs. 63 +/- 6% at 9 years; P = 0.009). Conclusions A transcatheter closure via a surgical TAp approach appears to be a safe and effective therapeutic option in selected high-risk patients with PVL and is associated with a lower hospital mortality than surgical treatment, in spite of higher predicted risk. Long-term survival remains suboptimal in these challenging patients. OI Giustino, Gennaro/0000-0002-5400-9516

Coronary obstruction (CO) is a rare but potentially fatal complication in patients undergoing transcatheter aortic valve replacement (TAVR). CO is most commonly caused by the displacement of a calcified native aortic valve leaflet toward the coronary ostium [(1)][1]. An 89-year-old woman underwent

Data on transcatheter aortic valve implantation (TAVI) for severe bicuspid aortic valve (BAY) stenosis and how this compares to that for tricuspid aortic valve (TAV) stenosis are limited. Twenty-one consecutive patients with BAV were treated with the Edwards or Core Valve bioprosthesis from November 2007 to December 2012 at San Raffaele Scientific Institute and Clinical Institute S. Ambrogio, Milan, Italy. Results were compared with a cohort of patients with TAV (n=447) treated with the same bioprostheses over the same period. Procedural 1- and 12-month outcomes were examined as defined by the Valve Academic Research Consortium criteria. Patients with BAY were younger (76.7 +/- 7.1 vs 79.8 +/- 7.4 years, p=0.06) and with a larger aortic annulus (25.0 +/- 1.8 vs 23.6 +/- 2.1 mm, p=0.01). Device success (85.7% vs 94.4%, p=0.10) was lower in patients with BAY. Although the 30-day composite safety end point (23.8% vs 21.0%, p=0.76) was similar between the 2 groups, mortality rate at 30 days was higher (14.2% vs 3.6%, p=0.02) in the BAY group. Cardiovascular mortality at 1 year did not differ significantly between the 2 groups (10.5% vs 7.4%, p=0.62). In conclusion, transcatheter aortic valve implantation in high surgical risk patients with severe BAY stenosis appears to be feasible with mid-term cardiovascular mortality similar to that for patients with TAV. Early survival and device success, however, were lower for patients with BAY demonstrating that further studies are required to identify which subset of patients with BAY is best suited for transcatheter treatment. (C) 2014 Elsevier Inc. All rights reserved. OI Naim, Charbel/0000-0002-4346-3991

Objectives This study sought to evaluate the impact of baseline activated clotting time (ACT)-guided heparin administration on major bleeding after transfemoral transcatheter aortic valve implantation (TAVI). Background Bleeding after TAVI is frequent and associated with unfavorable prognosis. Proper intraprocedural heparin dose administration may reduce the risk of potential overdosing in this frail study group. Methods Of the patients who underwent transfemoral TAVI in our center from November 1, 2007 to June 31, 2012, 362 were retrospectively analyzed. Because abnormally high baseline ACT values were noted, heparin was administered at the operator's discretion, according to baseline ACT (ACT-guided, n = 174) or patient's body weight (non-ACT-guided, n = 188). The primary study objective was 30-day major bleeding as defined by the Valve Academic Research Consortium criteria. Secondary objectives were any life-threatening, and minor bleeding, and other Valve Academic Research Consortium outcomes at 30 days. Results Bleeding occurred in 167 (46.1%) patients; of these, 76 (21.0%) had major bleeding. The ACT-guided group had a significantly lower occurrence of major (7.5% vs. 33.5%, p < 0.001), life-threatening (12.1% vs. 20.2%, p = 0.04), and any bleeding (25.9% vs. 64.9%, p < 0.001). Conversely, no differences were noted in the other study objectives. After adjustment for potential confounders, the protective odds ratio for ACT-guided therapy on major bleeding was 6.4 (95% confidence interval: 2.3 to 17.9; p < 0.001) at 30 days. Conclusions In our experience, heparin administration according to baseline ACT was correlated with a significantly lower occurrence of major bleeding in transfemoral TAVI. This strategy might be a useful tool in reducing bleeding in this high-risk study group. (C) 2014 by the American College of Cardiology Foundation OI Giustino, Gennaro/0000-0002-5400-9516

Patients who undergo transcatheter aortic valve implantation are generally discharged on dual-antiplatelet therapy. However, many of these patients also have indications for anticoagulant therapy, and it is unclear what the best antithrombotic strategy is in these cases. Data from 360 patients who underwent transcatheter aortic valve implantation were retrospectively analyzed, of whom 60 (16.7%) had indications for anticoagulant treatment, mainly because of atrial fibrillation. The antithrombotic regimen was decided according to clinical evaluation of thrombotic and hemorrhagic risk; most of these patients (n = 43) were discharged with warfarin plus a single antiplatelet drug. Their outcomes were compared to those in a group with no indications for anticoagulation (n = 300) treated with dual-antiplatelet therapy. During the follow-up period (median 11 months), 53 patients (15%) died; mortality was not associated with antithrombotic regimen. The incidence of cerebral events or intracranial hemorrhage (4.6% and 1.1%, respectively) was low in the study population, and no significant differences were detected between groups; the bleeding rate was also unaffected by antithrombotic therapy. In conclusion, when anticoagulation is indicated after transcatheter aortic valve implantation, many variables must be taken into account. The most frequent scenario in this study was patients in atrial fibrillation, most of whom were discharged with warfarin plus a single antiplatelet medication. When bleeding was a concern, especially in the absence of coronary disease, warfarin alone was prescribed. These results suggest that this approach is safe, but data from larger, randomized studies are needed.

Background. Vascular and bleeding complications remain important complications in patients undergoing percutaneous transfemoral transcatheter aortic valve implantation (TF-TAVI). Platelets play an important role in bleeding events. Mean platelet volume (MPV) is an indicator of platelet activation. The objective of this study was to assess whether low MPV is an indicator of major vascular and bleeding complications following TF-TAVI.Methods. A retrospective cohort study of 330 subjects undergoing TF-TAVI implantation was performed. The primary study endpoint was the occurrence of combined safety endpoint (CSEP); secondary endpoints included major vascular complications and life-threatening bleeding. Endpoints were defined according to Valve Academic Research Consortium 2.Results. The CSEP at 30 days was reached in 30.9%; major vascular complications were observed in 14.9% while life-threatening bleeding occurred in 20.6%. Logistic Euroscore and MPV were independent predictors of CSEP. Predictors of vascular complications were female sex, previous myocardial infarction, red blood cell distribution width (RDW), and MPV while predictors of life-threatening bleeding were peripheral arterial disease, RDW, and MPV.Conclusion. A low baseline MPV was shown for the first time to be a significant predictor of CSEP, major vascular complications, and life-threatening bleeding following TF-TAVI.

"OBJECTIVE:. TAVI is the alternative option in pts with AS deemed ineligible for surgery. Although mortality and morbidity are measures to assess the effectiveness of treatments, quality of life (QOL) should be an additional target. We assessed clinical outcome and QOL in octogenarians following TAVI.. DESIGN:. All octogenarians with a risk profile considered by the Heart Team to be unacceptable for surgery entered in this registry. QOL was assessed by questionnaires concerning physical and psychic performance.. PATIENTS:. A hundred forty-five octogenarians (age: 84.7 ± 3.4 years; male: 48.3%) underwent TAVI for AS (97.2%) or isolated AR (2.8%). NYHA class: 2.8 ± 0.6; Logistic EuroScore: 26.1 ± 16.7; STS score: 9.2 ± 7.7.Echocardiographic assessments included AVA (0.77 ± 0.21 cm2), mean\/peak gradients (54.5 ± 12.2\/88 ± 19.5 mm Hg), LVEF (21%=EF ≤ 40%), sPAP (43.1 ± 11.6 mmHg).. INTERVENTIONS:. All pts underwent successful TAVI using Edward-SAPIEN valve (71.2%) or Medtronic CoreValve (28.8%).. MAIN OUTCOME MEASURES:. Rates of mortality at 30 days, 6 months and 1 year were 2.8%, 11.2% and 17.5%.. RESULTS:. At 16-month follow up, 85.5% survived showing improved NYHA class (2.8 ± 0.6 vs 1.5 ± 0.7; p

Background Limited real-world data comparing outcomes after transcatheter (TAVR) and surgical aortic valve replacement (SAVR) in intermediate-surgical-risk patients with aortic stenosis are available. Methods We identified 182 consecutive patients who underwent TAVR via the transfemoral (TF) route (November 2007-February 2011) and 111 moderate-to-high-risk historical case controls undergoing SAVR (August 2003-July 2008). Using propensity score matching based on clinical characteristics and surgical risk scores, we compared clinical outcomes in 111 matched patients. Valve Academic Research Consortium definitions were applied for end point adjudication. Results Baseline clinical characteristics, in particular Logistic European System for Cardiac Operative Risk Evaluation (23.2 +/- 15.1 vs 24.4 +/- 13.4) and Society of Thoracic Surgeons score (4.6 +/- 2.3 vs 4.6 +/- 2.6), were well matched between groups. Transfemoral TAVR was associated with more vascular complications (33.3% vs 0.9%, P < .001). On the other hand, acute kidney injury was more frequent after SAVR (8.1% vs 26.1%, P < .001). The rates of all-cause mortality in both TF-TAVR and SAVR groups was1.8% at 30 days (P = 1.00) and 6.4% and 8.1%, respectively, at 1 year (P = .80). At 1 year, the rate of cerebrovascular events was similar in the 2 groups (4.6% vs 9.1%, P = .19). Conclusions In this real-world cohort of intermediate-surgical-risk patients with aortic stenosis, TF-TAVR and SAVR were associated with similar mortality rates during follow-up but with a different spectrum of periprocedural complications. Furthermore, the survival rate after TF-TAVR in this group of elderly patients with intermediate Society of Thoracic Surgeons score was encouraging. (Am Heart J 2012;164:910-7.)

Objective Transcatheter aortic valve implantation (TAVI) is increasingly accepted as an alternative procedure in patients with severe, symptomatic aortic stenosis and high risk for surgical aortic valve replacement. Transfemoral (TF) approach is the first option when feasible, but in case of peripheral vascular disease this approach is precluded. In our institution, for this kind of patients we considered transaxillary (TAx) approach as second choice and transapical (TAp) or transaortic (TAa) as last routes. This study describes short- and mid-term morbidity and mortality for TAx approach. Methods From November 2007 to March 2011, 284 patients underwent TAVI at our site; 229 treated by TF approach, 22 TAp, 2 TAa, and 31 TAx. Four patients were treated with an Edwards Sapien valve (Edwards Lifesciences, Inc., Irvine, CA USA) with TAx approach and 27 with CoreValve Revalving System (Medtronic Inc., Minneapolis, MN USA). TAx TAVI was performed in cath-laboratory with local anesthesia and mild sedation by a multispeciality valve team. We analyzed major adverse cardiac and cerebrovascular events, major adverse valve-related events, vascular complications, and 30 days and 6 months mortality. Results The procedural success rate (successful implantation of the device without intraprocedural mortality or need to conversion to open heart surgery) was 96.8% (30/31). Major adverse valve-related events were 12.9% (4/31). 30-day mortality was 6.4% (2/31) and actuarial survival at 6 months was 82.95% ± 7.96%. In one patient, procedure was converted to a TF CoreValve in emergency for hemodynamic instability after valvuloplasty due to severe difficulty to introduce the Edwards valve in the subclavian artery. Conclusions TAx approach is a feasible and technically simple procedure with encouraging results considering morbidity and mortality at short- and mid-term follow-up. TAx is a valid solution in patients with contraindications to TF approach and it is an alternative approach potentially less invasive than TAp or TAa.

A 46-year-old woman known with relapsing Hodgkin's lymphoma diagnosed at age 5, treated with repeated cycles of radiotherapy and chemotherapy, presented with severe symptomatic radiation-induced aortic stenosis. She also had other late sequelae of radiotherapy including thyroid cancer, mediastinal fribrosis and left pulmonary fibrosis with severe restrictive lung disease and a newly diagnosed renal carcinoma. Due to the prohibitively high surgical risk and need for urgent treatment, she underwent successful transcatheter aortic valve replacement with transfemoral implantation of a 23 mm Edwards SAPIEN-XT prosthesis, which was performed without valvuloplasty of the noncalcified fibrotic valve. The final result was excellent with reduction of the transaortic gradient and no residual aortic regurgitation.

Pulmonary vein stenosis after radiofrequency ablation occurs up to 3% and requires prompt diagnosis and treatment. Since clinical presentation is variable, a multimodality imaging approach currently provides an essential framework to address the diagnosis and appropriate treatment. A 40-year-old woman who had undergone surgical correction of sinus venosus atrial septal defect and partial anomalous pulmonary vein return required …

AIMS To assess outcomes after transcatheter aortic valve implantation (TAVI) according to sex, with the two available valves and four recognised delivery approaches. METHODS AND RESULTS VARC outcomes are reported according to sex for 305 high-risk patients consecutively treated in our centre, via available access routes utilising the Edwards SAPIEN™/SAPIEN™ XT or the Medtronic CoreValve ReValving System® devices. Three hundred and five patients underwent TAVI: 52.1% male and 47.9% female. Females had a smaller body surface area (1.84±0.16 m² vs. 1.70±0.16 m²; p

Objective: To investigate the predictors of moderate-to-severe aortic regurgitation (AR≥2+) after CoreValve implantation and evaluate the feasibility and safety of postdilatation in reducing the degree of AR. Background: Although transcatheter aortic valve implantation is an alternative treatment for high surgical risk patients with severe aortic stenosis, post-implantation paravalvular AR remains a complication. Methods: From July 2008 to July 2010, we enrolled 79 consecutive patients with severe aortic stenosis who underwent CoreValve implantation. Results: On univariable analysis, the predictors of AR≥2+ immediately after CoreValve implantation were: larger annulus size, low implantation, prosthesis mismatch, chronic renal insufficiency, a history of heart failure, and peripheral vascular disease. On multivariable analysis, the independent predictors of AR≥2+ were: larger annulus diameter (OR 1.78, 95%CI 1.25–2.55; P = 0.002), low implantation (OR 3.67, 95%CI 1.01–13.35, P = 0.05), and peripheral vascular disease (OR 3.54, 95%CI 1.19–10.56, P = 0.02). Post-CoreValve implantation, AR ≥ 2 was seen in 40.5% (32/79). Twenty-one patients underwent postdilatation with improvement in AR grade in the majority (17/21). Of the four patients who did not respond to postdilatation, two underwent valve-in-valve implantation. In one patient, the valve was pulled more proximally by the snare technique. The remaining 10 patients were treated conservatively. Conclusion: The appropriate strategy for treating patients with AR≥2+ depends on the causes and severity of AR post-TAVI. This study suggests that we should carefully select the size of CoreValve prosthesis to prevent prosthesis mismatch, especially when implanted in larger annulus sizes. For valves implanted in the appropriate position, postdilatation appears effective in reducing the degree of AR. © 2011 Wiley-Liss, Inc.

Objective: Trans-catheter aortic valve implantation (TAVI) is an alternative for patients not eligible for surgical aortic valve replacement. When peripheral access is not amenable by the transfemoral route (TF-TAVI), the most-used approaches are the trans-apical (TAp-TAVI) and the trans-axillary (TAx-TAVI). The aim of this study is to report the outcomes in a single-center series of consecutive patients treated by TAVI using the different approaches. Methods: From November 2007 to June 2010, 177 patients underwent TAVI by the same multispeciality valve team. TApTAVI was performed in the operative room, while TF-TAVI and TAx-TAVI were done in the catheterization laboratory. Follow-up was 100% complete (mean 6.0 6.8 months). Results: TF-TAVI, TAx-TAVI, and TAp-TAVI were performed in 140 (79.1%), 19 (10.7%), and 16 patients (9.1%), respectively. Thegroupswerenotdifferentintermsofage(p = 0.6),leftventricularejectionfraction(LVEF)(p = 0.6),Log-EuroSCORE(European System for Cardiac Operative Risk Evaluation) (p = 0.3), and Society of Thoracic Surgeons (STS) score (p = 0.7), while peripheral artery disease was higher in the TAp-TAVI and TAx-TAVI groups compared with the TF-TAVI group (p < 0.0001). The Charlson score was 10.7 14.9, 5.8 1.2, and 5.9 1.8 for TAp-TAVI, TAx-TAVI, and TF-TAVI, respectively (p = 0.02). In-hospital (30-day) mortality was 1.4% (2/140), 12.5% (2/16), and 5.3% (1/19) for TF, Tap, and TAx, respectively (p = 0.03). At follow-up, 6 months’ actuarial survival was 72.2 12.0%, 67.4 17.4%, and 88.4 3.1% for TAp-TAVI, TAx-TAVI, and TF-TAVI, respectively (p = 0.3). Conclusions: Similar to findings from recent, larger trials, patients undergoing TF-TAVI in high-risk patients had excellent 6-month results. Although TAx-TAVI was associated with lower hospital mortality, it shared the same 6-month outcomes of TAp-TAVI, probably due to a similar selection bias. # 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

OBJECTIVES: Our aim was to assess clinical outcome after transcatheter aortic valve implantation (TAVI) performed with the 2 commercially available valves with 3 delivery approaches selected in a stepwise fashion.BACKGROUND: Limited data exist on the results of a comprehensive TAVI program using different valves with transfemoral, transapical, and transaxillary approaches for treatment of severe aortic stenosis.METHODS: We report 30-day and 6-month outcomes of high-risk patients consecutively treated in a single center with either the Medtronic-CoreValve (MCV) (Medtronic, Minneapolis, Minnesota) or Edwards-SAPIEN valve (ESV) (Edwards Lifesciences, Irvine, California) delivered via the transfemoral or transaxillary approaches and ESV via the transapical approach.RESULTS: A total of 137 patients underwent TAVI: 107 via transfemoral (46 MCV and 61 ESV), 15 via transaxillary (12 MCV and 3 ESV), and 15 via transapical approach. After the transfemoral approach, the procedural success rate was 93.5%, and major vascular complication rate was 20.6%. No intra-procedural deaths occurred. The procedural success rates of transapical and transaxillary approaches were 86.6% and 93.3%, respectively. The 30-day mortality rate was 0.9% in transfemoral group and 13.3% in transapical, and no deaths occurred after transaxillary access. Cumulative death rate at 6 months was 12.2% in transfemoral, 26.6% in transapical, and 18.2% in transaxillary groups. At multivariable analysis, logistic European System for Cardiac Operative Risk Evaluation, body surface area, and history of cerebrovascular disease were significantly associated with an increased risk of major adverse cardiac and cerebrovascular events.CONCLUSIONS: Routine TAVI using both MCV and ESV with a selection of approaches is feasible and allows treatment of a wide range of patients with good overall procedural success rates and 30-day and 6-month outcomes.

Objective: Myocardial ischemic damage is reduced by volatile anesthetics in patients undergoing coronary artery bypass graft surgery. The authors tested the hypothesis that low-dose sevoflurane could decrease perioperative myocardial damage, as measured by cTnI release, when compared with placebo, in patients undergoing interventional cardiology procedures. Design: A single-blind, randomized controlled trial. Setting: A university hospital. Participants: Thirty patients undergoing stenting procedures (May 2005) were included in the present study. Interventions: The authors randomly assigned 16 patients to breathe sevoflurane (expired end-tidal concentration 1%) and 14 patients to breathe a placebo oxygen/air mix before stenting procedures. Measurements and Main Results: Postprocedural cardiac troponin I release was measured as a marker of myocardial necrosis. Sixteen patients had detectable cardiac troponin I levels after stenting procedures, with no difference between groups: 10 in the sevoflurane group (16 patients) versus 6 in the placebo group (14 patients) (p = 0.3). No difference in the amount of postprocedural median (interquartile range) cardiac troponin I release was noted between the sevoflurane group, 0.15 (0-4.73) ng/mL, and the placebo group, 0.14 (0-0.87) ng/mL (p = 0.4). Conclusions: Myocardial damage measured by cardiac troponin release was not reduced by the volatile anesthetic sevoflurane during interventional cardiology procedures in this study. (C) 2008 Elsevier Inc. All rights reserved.

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.

Nitroprusside (NTP) is used for the treatment of slow coronary flow (SCF) after coronary interventions. The wide variation in dosage, route, and timing of its administration in the reported studies prevents an objective assessment of its efficacy. We report the incidence and response to a standardized NTP protocol of SCF after successful stent implantation. Selective intracoronary administration of incremental doses (initial bolus of 80 microg incremented by 40 microg) of NPT was assessed in 21 patients who developed SCF in a series of 2,212 consecutive patients who underwent successful stent placement from January to October 2005. SCF was observed only in patients treated for acute myocardial infarction (AMI; 11.5%, 12 of 105) or saphenous vein graft (SVG) stenosis (8.2%, 9 of 109). An intracoronary bolus of nitroglycerin did not restore normal Thrombolysis In Myocardial Infarction (TIMI) flow in any patient. The first 80-microg dose of NTP restored normal TIMI flow in 58% of patients (7 of 12) with AMI and in 44% of patients (4 of 9)with SVG stenosis. The maximal dose (120/160 microg) restored normal TIMI flow in all remaining patients with AMI but in only 1 additional patient with SVG stenosis. At the end of the procedure, the percent decrease in corrected TIMI frame count was significantly larger in patients with AMI (-44+/-10%) than in those with SVG stenosis (-24+/-16%, p=0.02). In a large consecutive series of successful stent procedures, SCF was found only in patients with ST-elevation AMI (11.5%) or with a stenosed SVG (8.2%). In conclusion, the standardized protocol of intracoronary NTP administration succeeded in normalizing SCF in all patients with AMI but in only 5 of 9 patients with SVG stenosis. This latter subgroup requires other therapeutic strategies.

Aims To investigate the feasibility, image quality, and clinical implications of an ultra-low-dose contrast injection computed tomography angiography (CTA) protocol in patients scheduled for transcatheter aortic valve implantation (TAVI). Methods and results Images obtained with 64-slice CT were retrospectively evaluated in 162 TAVI candidates with a body mass index (BMI) of ≤29 kg/m2. A multiphasic, low iodine dose and BMI-adapted CM protocol was administered in all patients (BMI,22 kg/m2: 40 mL; BMI 22-29 kg/m2: 55 mL). All images were evaluated for image quality, vessel attenuation, and estimated radiation dose. The anatomy, diameters, perimeter, and area of the aortic annulus were assessed. Anatomy and diameters of peripheral vessels were also evaluated. Image quality of the aortic root and ilio-femoral vessels was diagnostic in all patients. Vascular attenuation was.200 HU at any vessel level. The mean diameters of the aortic annulus were 22±3 mm (range: 16-28 mm) × 26±3 mm (range: 20-33 mm); the mean perimeter was 77.0±7.1 mm. After CTA, a total of 137 patients (84.6%) underwent TAVI. Mean estimated radiation dose was 20.2±4.6 mSv. Conclusion With our protocol, we achieved images of the aortic annulus and aorto-iliac anatomy of sufficient quality to allow patient selection and procedural planning for TAVI, with a substantial reduction of the amount of injected CM.

In the letter by Brocco et al, the authors focused on the correspondence between clinical relevance and statistical significance. The decision to emphasize study results as clinically relevant but not statistically significance is quite controversial in relatively small retrospective studies with exploratory purposes such as our study.1 In our opinion, a pragmatic “win criterion” for these kinds of studies would be the simultaneous achievement of both clinical and statistical significance. We do not believe that not mentioning as clinically relevant a non–statistically significant difference can substantially bias the readers’ conclusions any more than emphasizing as noteworthy a difference that is potentially coincidence. In the letter by Pocar et al, different issues are raised. The authors pointed out the problem of the incomplete revascularization (IR), which is frequently evoked as a limitation of percutaneous transluminal coronary angioplasty as compared with bypass …

Transcatheter heart valve (THV) implantation with the valve-in-valve technique is a low-risk treatment option for patients with failing bioprosthetic valves ([1][1]). A 71-year-old man with rheumatic mitral stenosis underwent mitral valve replacement 12 years ago with a 27-mm Carpentier-Edwards