Clinical and hemodynamic results after direct transcatheter aortic valve replacement versus pre-implantation balloon aortic valvuloplasty: A case-matched analysis.

OBJECTIVES: To evaluate the safety and midterm hemodynamic results of direct transcatheter aortic valve replacement (TAVR) without pre-implantation balloon aortic valvuloplasty (BAV). BACKGROUND: BAV was considered a mandatory previous step in TAVR procedures. METHODS: A total of 339 consecutive patients who underwent transfemoral TAVR were prospectively selected. A 1:1 matching was conducted, pairing age, prosthesis type (self-expandable or balloon expandable) and size, and valve calcification grade (48% with moderate to severe valve calcification). Finally, 102 pairs (102 patients with previous BAV and 102 without BAV) were obtained. RESULTS: Direct TAVR was feasible in all patients without any crossover to BAV group. Device success was achieved in 91.2% and 90.2% of cases in direct TAVR and pre-BAV groups (P = 0.810), respectively, without any differences in balloon postdilation rate and residual aortic regurgitation. The amount of contrast agent, acute kidney injury and myocardial injury was significantly lower in the direct implantation group (P < 0.05). No differences were found in 30-day and 1-year mortality between both groups (4.9% vs. 9.8%, P = 0.177 and 14.0% vs. 23.8%, P = 0.771, respectively). Hemodynamic parameters remained stable after 1-year follow-up in both groups. CONCLUSIONS: Direct transfemoral TAVR without prior BAV was safe in patients with calcified severe aortic stenosis. Pre-implantation BAV could be omitted in patients undergoing TAVR, without influence in procedure success rate, and subsequent patients' clinical course and valve hemodynamic performance. © 2016 Wiley Periodicals, Inc.

Infective endocarditis after transcatheter aortic valve implantation: results from a large multicenter registry.

BACKGROUND: We aimed to determine the incidence, predictors, clinical characteristics, management, and outcomes of infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: This multicenter registry included 53 patients (mean age, 79±8 years; men, 57%) who suffered IE after TAVI of 7944 patients after a mean follow-up of 1.1±1.2 years (incidence, 0.67%, 0.50% within the first year after TAVI). Mean time from TAVI was 6 months (interquartile range, 1-14 months). Orotracheal intubation (hazard ratio, 3.87; 95% confidence interval, 1.55-9.64; P=0.004) and the self-expandable CoreValve system (hazard ratio, 3.12; 95% confidence interval, 1.37-7.14; P=0.007) were associated with IE (multivariate analysis including 3067 patients with individual data). The most frequent causal microorganisms were coagulase-negative staphylococci (24%), followed by Staphylococcus aureus (21%) and enterococci (21%). Vegetations were present in 77% of patients (transcatheter valve leaflets, 39%; stent frame, 17%; mitral valve, 21%). At least 1 complication of IE occurred in 87% of patients (heart failure in 68%). However, only 11% of patients underwent valve intervention (valve explantation and valve-in-valve procedure in 4 and 2 patients, respectively). The mortality rate in hospital was 47.2% and increased to 66% at the 1-year follow-up. IE complications such as heart failure (P=0.037) and septic shock (P=0.002) were associated with increased in-hospital mortality. CONCLUSIONS: The incidence of IE at 1 year after TAVI was 0.50%, and the risk increased with the use of orotracheal intubation and a self-expandable valve system. Staphylococci and enterococci were the most common agents. Although most patients presented at least 1 complication of IE, valve intervention was performed in a minority of patients, and nearly half of the patients died during the hospitalization period.

Selected CD133⁺ progenitor cells to promote angiogenesis in patients with refractory angina: final results of the PROGENITOR randomized trial.

RATIONALE: Refractory angina constitutes a clinical problem. OBJECTIVE: The aim of this study was to assess the safety and the feasibility of transendocardial injection of CD133(+) cells to foster angiogenesis in patients with refractory angina. METHODS AND RESULTS: In this randomized, double-blinded, multicenter controlled trial, eligible patients were treated with granulocyte colony-stimulating factor, underwent an apheresis and electromechanical mapping, and were randomized to receive treatment with CD133(+) cells or no treatment. The primary end point was the safety of transendocardial injection of CD133(+) cells, as measured by the occurrence of major adverse cardiac and cerebrovascular event at 6 months. Secondary end points analyzed the efficacy. Twenty-eight patients were included (n=19 treatment; n=9 control). At 6 months, 1 patient in each group had ventricular fibrillation and 1 patient in each group died. One patient (treatment group) had a cardiac tamponade during mapping. There were no significant differences between groups with respect to efficacy parameters; however, the comparison within groups showed a significant improvement in the number of angina episodes per month (median absolute difference, -8.5 [95% confidence interval, -15.0 to -4.0]) and in angina functional class in the treatment arm but not in the control group. At 6 months, only 1 simple-photon emission computed tomography (SPECT) parameter: summed score improved significantly in the treatment group at rest and at stress (median absolute difference, -1.0 [95% confidence interval, -1.9 to -0.1]) but not in the control arm. CONCLUSIONS: Our findings support feasibility and safety of transendocardial injection of CD133(+) cells in patients with refractory angina. The promising clinical results and favorable data observed in SPECT summed score may set up the basis to test the efficacy of cell therapy in a larger randomized trial.

Disturbed coronary hemodynamics in vessels with intermediate stenoses evaluated with fractional flow reserve: a combined analysis of epicardial and microcirculatory involvement in ischemic heart disease.

BACKGROUND: In chronic ischemic heart disease, focal stenosis, diffuse atherosclerotic narrowings, and microcirculatory dysfunction (MCD) contribute to limit myocardial flow. The prevalence of these ischemic heart disease levels in fractional flow reserve (FFR) interrogated vessels remains largely unknown. METHODS AND RESULTS: Using intracoronary measurements, 91 coronaries (78 patients) with intermediate stenoses were classified in 4 FFR and coronary flow reserve (CFR) agreement groups, using FFR>0.80 and CFR<2 as cutoffs. Index of microcirculatory resistance (IMR) and atherosclerotic burden (Gensini score) were also assessed. MCD was assumed when IMR≥29.1 (75(th) percentile). Fifty-four (59.3%) vessels had normal FFR, from which only 20 (37%) presented both normal CFR and IMR. Among vessels with FFR>0.80, most (63%) presented disturbed hemodynamics: abnormal CFR in 28 (52%) and MCD in 18 (33%). Vessels with FFR>0.80 presented higher IMR [adjusted mean 27.6 (95% confidence interval, 23.4-31.8)] than those with FFR≤0.80 [17.3 (95% confidence interval, 13.0-21.7), p=0.001]. Atherosclerotic burden was inversely correlated with CFR (r=-0.207, P=0.055), and in vessels with FFR>0.80 and CFR<2 (n=28, 39%), IMR had a wide dispersion (7-72.7 U), suggesting a combination of diffuse atherosclerotic narrowings and MCD. Vessels with FFR≤0.80 and normal CFR presented the lowest IMR, suggesting a preserved microcirculation. CONCLUSIONS: A substantial number of coronary arteries with stenoses showing an FFR>0.80 present disturbed hemodynamics. Integration of FFR, CFR, and IMR supports the existence of differentiated patterns of ischemic heart disease that combine focal and diffuse coronary narrowings with variable degrees of MCD.

Transfemoral implantation of Edwards Sapien XT aortic valve without previous valvuloplasty: role of 2D/3D transesophageal echocardiography.

BACKGROUND: Balloon valvuloplasty (BAV) has been considered a mandatory step before TAVI. However, it might be related to cerebrovascular microembolizations, atrioventricular conduction disturbances, and hemodynamic instability. The aim of this study is to describe transesophageal echocardiography characteristics of patients that could benefit from direct transfemoral transcatheter aortic valve implantation (TAVI) of Edwards SAPIEN XT, without previous BAV. METHODS AND RESULTS: A total of 16 patients with direct implantation of an Edwards SAPIEN XT valve are included. Preprocedural echocardiographic findings were exhaustively analyzed and described. From 32 patients elected for transfemoral TAVI with an Edwards SAPIEN XT, 16 of them (50%) were selected for direct implantation using the Edwards SAPIEN XT valve of size 23 mm (n = 5), 26 mm (n = 8), or 29 mm (n = 3). Patients selection for direct TAVI presented three echocardiographic conditions: central effective orifice, moderate to severe calcification of the aortic valve apparatus preserving leaflets movement, and symmetric distribution of calcium with absent to moderate central aortic regurgitation. Mean age was 81.4 ± 7.4, 75% female, with a mean logistic Euroscore 18.2 ± 11.2. Preprocedural mean valve gradient was 43.6 ± 16.3. Mean effective orifice area was 0.7 ± 0.2. There was no valve embolization and the success rate was 100%. Postdilation was performed in one patient (6.25%). New permanent pacing was needed in two patients (12.5%). CONCLUSIONS: TAVI without previous BAV is feasible and safe. 2D/3D TEE is an essential tool to select the patients that could benefit from this technique.

Feasibility and safety of transfemoral implantation of Edwards SAPIEN XT prosthesis without balloon valvuloplasty in severe stenosis of native aortic valve.

OBJECTIVES: Balloon valvuloplasty (BV) before transcatheter aortic implantation has been thought to be mandatory before the valve is implanted. We have explored the feasibility and safety of direct implantation of balloon expandable Edwards SAPIEN XT valve without prior balloon dilatation. BACKGROUND: Some complications after transcatheter aortic valve replacement (TAVR) have been associated with unwanted effects of BV, mainly the contribution to stroke and severe aortic regurgitation (AR) before the valve is implanted. Direct implantation with a self-expanding aortic valve has been recently reported. METHODS: From November 2011 to April 2012, ten patients were selected that met the following criteria in the transesophageal echocardiography (TEE): moderate calcification, homogeneous distribution of calcium, symmetrical opening of the valve, and some degree of aortic insufficiency. RESULTS: All patients had symptomatic aortic stenosis of a native valve and high surgical risk; six patients had the valve mildly calcified, in four patients the degree of calcification was moderate. The native valve was crossed and the prosthetic aortic valve was properly positioned in all cases and implanted in the correct position. No patient underwent post-dilatation and trivial AR was present in four patients. There were no adverse events (death, need for pacemaker, myocardial infarction, or stroke). At 30 days post-procedure, all patients were alive and had significant clinical improvement. CONCLUSIONS: Direct implantation of Edwards SAPIEN XT without prior BV in selected cases is feasible and safe. The number of patients in whom this technique would be applicable, and their impact on reducing complications has to be determined.

Double bifurcation lesion treated with double Tryton Sidebranch Stent: first case report.

The optimal percutaneous treatment strategy for coronary bifurcation lesions is still unknown. Several dedicated coronary bifurcation stents, such as the Tryton Side Branch Stent™ (Tryton Medical, Durham, NC) have been developed to improve clinical outcomes. We presented a double bifurcation lesion case treated with two Tryton sidebranch stents, with a single drug eluting stent covering the main vessel and both bifurcations.

Local Intracoronary Fibrinolysis with Distal Occlusion: A Series of Cases Using Marinade Technique.

No-reflow phenomenon is frequent in patients with ST-segment elevation myocardial infarction (STEMI) and has proven to be a strong predictor of mortality. Local fibrinolytic infusion with distal coronary occlusion (previously described as "marinade technique") can be useful in patients with acute myocardial infarction and intraluminal thrombus refractory to aspiration enabling the local effect of the drug, directly applied inside the thrombus, while protecting the microvasculature with prolonged inflation of a distal balloon. We present the early experience of four patients with inferior acute myocardial infarction and high thrombus burden successfully treated with marinade technique in one center.

Edge-to-edge percutaneous repair of severe mitral regurgitation--state-of-the-art for Mitraclip® implantation.

MitraClip® therapy is a percutaneous edge-to-edge plication of the mitral leaflets, mimicking the Alfieri surgical technique. MitraClip® implantation is a safe procedure, and survival outcomes in high-surgical-risk patients are superior to historical controls. Despite these results, questions remain concerning long-term efficacy and durability. The MitraClip® device has been studied in a safety and feasibility trial in the USA, a randomized pivotal trial against surgical mitral valve repair. Moreover, MitraClip® now has over 2 years of CE-mark approval and a rapidly expanding clinical experience in Europe, primarily in patients at high risk for surgery. A dedicated multidisciplinary team is necessary, as well as thoughtful patient selection, familiarity with the technical aspects of the procedure, including transesophageal ultrasound imaging and post-procedure monitoring. Currently available clinical data and procedural steps are herein reviewed. Because the MitraClip® procedure is still relatively new, continued investigation is required to further better define the patient populations that will benefit most.

Primary angioplasty vs. fibrinolysis in very old patients with acute myocardial infarction: TRIANA (TRatamiento del Infarto Agudo de miocardio eN Ancianos) randomized trial and pooled analysis with previous studies.

AIMS: To compare primary percutaneous coronary intervention (pPCI) and fibrinolysis in very old patients with ST-segment elevation myocardial infarction (STEMI), in whom head-to-head comparisons between both strategies are scarce. METHODS AND RESULTS: Patients ≥75 years old with STEMI <6 h were randomized to pPCI or fibrinolysis. The primary endpoint was a composite of all-cause mortality, re-infarction, or disabling stroke at 30 days. The trial was prematurely stopped due to slow recruitment after enrolling 266 patients (134 allocated to pPCI and 132 to fibrinolysis). Both groups were well balanced in baseline characteristics. Mean age was 81 years. The primary endpoint was reached in 25 patients in the pPCI group (18.9%) and 34 (25.4%) in the fibrinolysis arm [odds ratio (OR), 0.69; 95% confidence interval (CI) 0.38-1.23; P = 0.21]. Similarly, non-significant reductions were found in death (13.6 vs. 17.2%, P = 0.43), re-infarction (5.3 vs. 8.2%, P = 0.35), or disabling stroke (0.8 vs. 3.0%, P = 0.18). Recurrent ischaemia was less common in pPCI-treated patients (0.8 vs. 9.7%, P< 0.001). No differences were found in major bleeds. A pooled analysis with the two previous reperfusion trials performed in older patients showed an advantage of pPCI over fibrinolysis in reducing death, re-infarction, or stroke at 30 days (OR, 0.64; 95% CI 0.45-0.91). CONCLUSION: Primary PCI seems to be the best reperfusion therapy for STEMI even for the oldest patients. Early contemporary fibrinolytic therapy may be a safe alternative to pPCI in the elderly when this is not available.

Percutaneous Intervention With GuideLiner Catheter in 4 Patients With Anomalous Coronary Artery Originating From Opposite Sinus of Valsalva.

Percutaneous intervention in anomalous coronary arteries originating from the opposite sinus of Valsalva is complicated by their unusual location and course, which makes selective cannulation difficult. The GuideLiner (Vascular Solutions, Inc.) is a monorail guide extension catheter designed to advance beyond the tip of a mother guide catheter to enable deep intubation of a coronary artery, provide extra support, and improve coaxial alignment. We describe the cases of 4 patients with an anomalous coronary artery originating from the opposite sinus of Valsalva-including 2 with acute myocardial infarction-who underwent successful percutaneous coronary intervention with use of a GuideLiner catheter.

Thrombus formation after left atrial appendage exclusion using an Amplatzer cardiac plug device.

The feasibility and safety of left atrial appendage closure with the Amplatzer cardiac plug (AGA Medical Corp., Minneapolis, MN) have been recently published; no thrombus formation on the device surface has been reported previously. We describe a case of a 66-year-old man with permanent atrial fibrillation, previous stroke, and contraindication for long-term oral anticoagulant therapy. A 22-mm ACP device was deployed successfully without complications. The patient was discharged on acetyl salicylic acid 100 mg and clopidogrel 75 mg daily. After 4 weeks, the patient was admitted for a lower gastrointestinal bleeding and clopidogrel was stopped. A 3-month follow-up echocardiogram confirmed the exclusion of the LAA but it demonstrated the presence of a thrombus on the atrial surface of the device. It was decided to keep the patient on acetyl salicylic acid 100 mg with the addition of enoxaparin 60 mg bid. Transesophageal echocardiogram demonstrated total resolution of the thrombus after 2 months.

Acute left ventricle diastolic function improvement after transcatheter aortic valve implantation.

AIMS: Data regarding the effects of TAVI on LV after are scarce and conflicting results have been reported immediately after aortic valvuloplasty. This study aimed to determine the acute haemodynamic effects of transcatheter aortic valve implantation (TAVI) in left ventricle (LV) diastolic performance, immediately after aortic valvuloplasty and prosthesis deployment. METHODS AND RESULTS: Sixty-one patients with severe aortic valve stenosis, and preserved LV systolic function submitted to successful TAVI, were included. All procedures were guided through transoesophageal echocardiography, and parameters of diastolic function were evaluated before and minutes after TAVI. The mean age was 83.5±6 years and mean log EuroSCORE was 18.2±9.4. Before the procedure, all patients presented LV diastolic dysfunction. Immediately after TAVI, fewer patients presented a restrictive pattern [27 (44.3%), before the procedure, vs. 20 (34.4%), after TAVI (P=0.047)], and an increase in E wave deceleration time (211.2±75.5 vs. 252.7±102.3 cm/s, P=0.001), in E wave velocity (109.5±41.2 vs. 120.3±43.6 cm/s, P=0.025), and in isovolumetric relaxation time (83±36.5 vs. 97.1±36.0 ms, P=0.013) was observed. On multivariate analysis of covariance (ANCOVA), adjusting to LV systolic function, heart rate, blood pressure, and haematocrit values, the results remained significant. Patients referred to percutaneous approach had invasive haemodynamic data collected, showing a decrease in LV end-diastolic pressure after valve implantation [18.8±5.7 vs. 14.7±4.7, mean difference -4.1 (95% CI: -5.9; -2.9)]. Patients with a restrictive pattern immediately after TAVI presented a smaller decrease in LV end diastolic pressure (-3.3±4.7) than those with diastolic dysfunction grade I or II (-9.5±4.7; P=0.017). CONCLUSION: This is the first study describing LV diastolic performance during TAVI. Our results show improvement in diastolic function parameters in patients with preserved LV systolic function, immediately after successful TAVI.

Successful percutaneous treatment of occlusive spontaneous coronary artery dissection with a 'pull-back injection technique': case report.

BACKGROUND: Spontaneous coronary artery dissection (SCAD) is a rare condition that can cause acute coronary syndrome, typically in young patients without classical cardiovascular risk factors. Although in SCAD the conservative management is preferable, in cases with complete occlusion of the artery an invasive treatment may be required. In such cases, the goal of the percutaneous intervention should be to restore the connection between the true and false lumen recovering the distal flow of the vessel. CASE SUMMARY: A young man was admitted with acute chest pain and ST segment elevation in precordial v3-v6 leads. An emergent coronary angiogram showed an abrupt occlusion of middle left anterior descending artery compatible with SCAD. A microcatheter was advanced distally into the artery and pulled back with continuous contrast injection through the catheter, restoring the distal flow with a residual spiroid intimal flap and with relief of the chest discomfort. A computed tomography performed during admission showed complete resolution of the lesion. DISCUSSION: In SCAD with complete occlusion of the vessel, the 'pull-back technique' with continuous vigorous injection of contrast through a distal microcatheter may be effective to restore the distal flow enabling the healing of the artery at follow-up and avoiding the stent implant.

Case report of an acute coronary syndrome in a patient with artery coronary fistulae.

BACKGROUND: Coronary artery fistulae are rare vascular anomalies. Although they are usually asymptomatic, the presence of symptoms might present a challenge in the diagnostic and therapeutic management. CASE SUMMARY: We present a patient with chest pain whose initial tests were normal, but coronary artery fistulae were found. Single-photon emission computed tomography test showed ischaemia due to coronary artery fistulae and cardiac computed tomography helped in the planning of the percutaneous closure. DISCUSSION: CCT is emerging as an optimal non-invasive tool to characterise the morphology and course of coronary artery fistulae and may be essential for its accurate diagnosis and planning for percutaneous closure.

Transradial Secondary Approach During Transfemoral TAVI: Usefulness of Placing a Wire Before Femoral Puncture for Management and Treatment of Vascular Complications.

Vascular complications during transcatheter aortic valve implantation (TAVI) are relatively common, and some of them related to the transfemoral secondary access. The use of the transradial access (TRA) as an alternative vascular approach for transfemoral TAVI could reduce these complications, however, the treatment of potential vascular peripheral issues from this access has been scarcely described. The advance of a wire from the TRA to the primary transfemoral access at the beginning of the procedure could help the management of eventual vascular complications. A new TRA technique during transfemoral TAVI procedures is described, reporting the results in the first forty-two patients in one center.

Diagnostic and Prognostic Value of Coronary Computed Tomography Angiography in Patients with Severe Calcification.

Our aim was to analyze its diagnostic and prognostic value in patients with high coronary calcium score (CCS). A total of 113 patients with CCS > 400 were included. Significant coronary artery disease (CAD) was defined as stenosis ≥ 50%. Invasive coronary angiography and major cardiovascular events were recorded. The CCS and heart rate during the acquisition were significantly lower in the diagnostic coronary computed tomography angiography (CCTA) group. The cut-off value of CCS to establish the diagnostic utility of CCTA was 878. The rate of cardiovascular events was 9.3%. The positive predictive value of CCTA to detect significant CAD was 73.5% and the negative predictive value for predicting cardiovascular events was 96%. In patients with high CCS, CCTA is useful to evaluate CAD, especially when the CCS is lower or equal to 878; moreover, the prognostic value of CCTA is better in patients where significant CAD has been ruled out.

Local Intracoronary Fibrinolysis in Acute Myocardial Infarction of Ectatic Coronary Arteries in the Post-Abciximab Era.

Percutaneous intervention in the context of coronary artery ectasia (CAE) is penalized with no-reflow phenomenon. The glycoprotein-IIb/IIIa-inhibitor abciximab was the most accepted method for pharmacology thrombus resolution in this scenario, nevertheless, this agent was recently withdrawn. We describe 5 patients treated with local intracoronary fibrinolysis administrated through predesigned catheters in the setting of AMI and CAE.

Percutaneous closure of an atrial septal defect in a patient with Ebstein anomaly and right-to-left shunt.

Ebstein anomaly is a congenital disease frequently associated with atrial septal defects, which can generate a right-to-left shunt, leading to systemic desaturation and right ventricular failure. We describe the case of a 68-year-old man with central cyanosis due to Ebstein anomaly and a patent foramen ovale. An atrial septal occluder was initially implanted after having performed prolonged test occlusion of the interatrial communication. In this case, device embolization occurred due to high right pressure. Percutaneous closure of atrial septal defects in the presence of a right-to-left shunt can offer a significant clinical improvement in selected cases. In patients with Ebstein anomaly, the implantation of atrial septal defect closure devices may be desirable, due to the larger size of the waist, which may provide better stability in the event of an increase in right pressure.