Five-Year Clinical Outcome and Valve Durability After Transcatheter Aortic Valve Replacement in High-Risk Patients.

BACKGROUND: The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry. METHODS: The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions. RESULTS: Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at <2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to <5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47-1.07; P=0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%). CONCLUSIONS: The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.

Rotational atherectomy for left main coronary artery disease in octogenarians: transradial approach in a tertiary center and literature review.

OBJECTIVES: The aim of this study was to appreciate the safety and effectiveness of transradial percutaneous coronary intervention (PCI) with rotational atherectomy for highly calcified left main coronary artery (LMCA) disease in octogenarians. BACKGROUND: Conventional surgery is still considered the preferred management for LMCA disease; but, when the lesion is severely calcified, and the patient is unsuitable for surgery, the interventional cardiologist faces a complex PCI traditionally approached by femoral access. METHODS: Between June 2004 and December 2010, octogenarians with calcified LMCA disease who were primary denied for surgical revascularization were enrolled. Procedural success and major adverse cerebral and cardiovascular events (MACCE) including death, nonfatal myocardial infarction, target lesion revascularization (TLR), or stroke during long-term follow-up were evaluated. RESULTS: Forty-two consecutive patients ≥80 years had undergone stenting for calcified LMCA disease (13 with rotational atherectomy, the "Rota" group, and 29 without rotational atherectomy, the "without Rota" group). Procedural success was good (92.3% vs. 96.6%, respectively, p = NS). Mean follow-up time was 25.7 ± 21.4 and 28 ± 32.3 months, respectively. There was a TLR in 25% and 11.1%, respectively; p = NS. No difference was detected in terms of overall in-hospital or long-term mortality or MACCE. CONCLUSION: Rotational atherectomy followed by stent implantation by transradial approach, when applied to heavily calcified lesions, appeared to be a safe and effective strategy for the treatment of LMCA disease in octogenarians who were refused for surgery.

Thrombus-aspiration through 5 Fr guiding catheter with transradial approach in acute coronary syndromes: feasibility of a mini-invasive strategy.

OBJECTIVES: The purpose of this study was to assess the feasibility and safety of thrombus-aspiration through a 5 Fr guiding catheter with transradial approach in acute coronary syndromes. BACKGROUND: The use of thrombus-aspirating devices improves myocardial reperfusion but requires at least a 6 Fr guiding catheter. Transradial coronary interventions using a 5 Fr guiding catheter are attractive to reduce bleeding complications. METHODS: We retrospectively selected patients presenting acute coronary syndromes with angiographically visible thrombus who underwent thrombus-aspiration through radial access using a 4 Fr multipurpose catheter in a 5 Fr guiding catheter. We described clinical and angiographic characteristics of the cohort, and the procedure's technique, success and complications. RESULTS: Among the 34 included patients, 29 presented ST-segment elevation myocardial infarction. Complete resolution of the ST-segment elevation was effective in 93% of these patients. TIMI flow grade after thrombus-aspiration was significantly improved compared to baseline TIMI flow grade or after passage of the guidewire (P < 0.001 for both). There was no dissection or perforation but we noted distal embolization in 5 cases probably explained by the high grade of intracoronary thrombus in our cohort. CONCLUSION: Thrombus-aspiration through a 5 Fr guiding catheter with transradial approach seems to be safe and effective in selected patients with acute coronary syndrome. This mini-invasive approach brought the advantages of the transradial access in 5 Fr but also its limitations.

Percutaneous balloon atrioseptostomy for left heart discharge in extracorporeal life support patients with persistent pulmonary edema.

AIMS: In severe myocardial dysfunction, extracorporeal life support (ECLS) can preserve organ perfusion. Occasionally, the high resulting afterload can lead to refractory pulmonary edema. We report our experience with percutaneous balloon atrioseptostomy used in this circumstance to discharge the left heart and prevent worsening pulmonary congestion. METHODS AND RESULTS: Between October 2002 and December 2009, 5 patients, with a mean age of 39 years, who were under peripheral ECLS underwent percutaneous balloon atrioseptostomy for refractory worsening pulmonary edema as determined by clinical, radiological, and echocardiographic criteria. Myocardial dysfunction was related to drug poisoning in 2 cases and to myocarditis in the 3 others. Atrioseptostomy successfully improved pulmonary edema and echocardiographic indices of left ventricular function in all cases. Four patients were eventually discharged. The fifth patient died in hospital due to multiorgan failure. CONCLUSIONS: In our experience, percutaneous balloon atrioseptostomy appeared to be a rapid, effective, and minimally invasive technique for offloading the left heart of patients with a reversible cardiac dysfunction under ECLS and suffering from refractory pulmonary edema.

Prinzmetal angina or coronary spasm related to anaphylactoid reaction?

Prinzmetal's angina is a challenging diagnostic of spontaneous brief episodes of chest pain. Anaphylactoid reactions to radiocontrast media are immediate hypersensitivity responses that can mediate coronary artery spasm. Herein, we report the case of a 61-year-old man who underwent a coronary angiography for angina. The right coronary artery (RCA) was first visualized as normal, but during the left coronary system injections, he developed ST segment elevation and cardiogenic shock. No iatrogenic dissection of the left coronary system, which was initially normal, was displayed, but surprisingly, a retrograde supply to the RCA was visualized. Thus, we re-catheterized the RCA, which indicated a total occlusion of its second segment. Nitrate injections completely relieved the spasm and the clinical condition of the patient normalized. The possible related mechanisms are also discussed.

Echocardiographic assessment of pulmonary vascular resistance in pulmonary arterial hypertension.

BACKGROUND: Echocardiographic ratio of peak tricuspid regurgitant velocity to the right ventricular outflow tract time-velocity integral (TRV/TVI rvot) was presented as a reliable non-invasive method of estimating pulmonary vascular resistance (PVR). Studies using this technique in patients with moderate to high PVR are scarce. Left ventricular outflow tract time-velocity integral (TVI lvot) can be easier to measure than TVI rvot, especially in patients with severe pulmonary hypertension (PH) with significant anatomical modifications of the right structures. AIMS: We wanted to determine whether the TRV/TVI rvot and TRV/TVI lvot ratios would form a reliable non-invasive tool to estimate PVR in a cohort of patients with moderate to severe pulmonary vascular disease. METHODS: Doppler echocardiographic examination and right heart catheterisation were performed in 37 patients. Invasive PVR was compared with TRV/TVI rvot and TRV/TVI lvot ratios using regression analysis. Two equations were modelled and the results compared with invasive measurements using the Bland-Altman analysis. Using receiver-operating characteristics curve analysis, a cut-off value for the two ratios was generated. RESULTS: Correlation coefficients between invasive PVR and TRV/TVI rvot then TRV/TVI lvot were respectively 0.76 and 0.74. Two new equations were found but the Bland-Altman analysis showed wide standard deviations (respectively 3.8 and 3.9 Wood units). A TRV/TVI rvot then TRV/TVI lvot ratio cut-off value of 0.14 had a sensitivity of 93% and a specificity of 57% for the first and a sensitivity of 87% and a specificity of 57% for the second to determine PVR > 2 Wood units. CONCLUSION: Echocardiography is useful for the screening of patients with pulmonary hypertension and PVR > 2 WU. It remains disappointing for accurate assessment of high PVR. TVI lvot may be an alternative to TVI rvot for patients for whom accurate TVI rvot measurement is not possible.

Cerebral microembolism during cardiac catheterization and risk of acute brain injury: a prospective diffusion-weighted magnetic resonance imaging study.

BACKGROUND AND PURPOSE: Cerebral microembolism detected by transcranial Doppler occurs systematically during cardiac catheterization, but its clinical relevance remains unknown. Studies suggest that asymptomatic embolic cerebral infarction detectable by diffusion-weighted (DW) MRI might exist after percutaneous cardiac interventions, especially after retrograde catheterization of the aortic valve in patients with valvular aortic stenosis, with a frequency as high as 22% of cases. We investigated the incidence of new ischemic lesions on serial cerebral DW MRI after cardiac catheterization. METHODS: This prospective study involved 46 patients with severe aortic valve stenosis. To assess the occurrence of cerebral infarction, all patients underwent cerebral DW MRI and neurological assessment within 24 hours before and 48 hours after cardiac catheterization and retrograde catheterization of the aortic valve. A subgroup was monitored by transcranial power M-mode Doppler during cardiac catheterization to observe cerebral blood flow and track emboli. RESULTS: One patient had a focal diffusion abnormality on DW MRI before cardiac catheterization. After catheterization, we detected only 1 additional acute cerebral diffusion abnormality in a single case (2.2%), although cerebral microemboli were detected in all transcranial Doppler-monitored patients during cardiac catheterization, as expected. All patients remained asymptomatic. Based on these results a mid-point incidence of 5.9% (95% CI, 0.01 to 12.5) for abnormalities on DW MRI in asymptomatic cardiac catheterization patients in our center can be assigned. CONCLUSIONS: Unsuspected cerebral infarctions can be detected by DW MRI after cardiac catheterization, but this phenomenon remains unfrequent in our series. Further studies are needed to identify factors explaining the discrepancy between these results and those of previous studies.

Antecubital vs Femoral Venous Access for Right Heart Catheterization: Benefits of a Flashback.

BACKGROUND: Although rare, complications of right heart catheterization (RHC) are usually related to the access site. Antecubital venous access for RHC allows immediate ambulation and may reduce access-site complications, but data on this approach are scarce. METHODS: Our study prospectively collected comprehensive data from consecutive RHCs performed at our academic center between February 2010 and August 2013. Demographic, procedural, and in-hospital outcomes were compared between patient groups defined by antecubital and femoral approaches. RESULTS: A total of 1007 RHC procedures was performed; 895 (88.9%) were performed through an antecubital approach and 112 (11.1%) were performed through a femoral approach. Antecubital attempts were successful in 92.8% of the clinically eligible patients. The antecubital approach was associated with a shorter procedure duration and fluoroscopy time as well as a lower radiation dose (P < 0.001 for all) compared with femoral access. Radiation dose and fluoroscopy time were significantly reduced (P < 0.001 for both) when antecubital procedures were performed by experienced operators compared with trainees. Periprocedural complications occurred in 8 patients (0.8%) (leading to prolonged hospitalization in only 1 patient in the femoral group). Access-site hematoma occurred more frequently in the femoral group (P < 0.001). CONCLUSIONS: An antecubital venous approach is a feasible alternative to femoral venous access for RHC. Shorter fluoroscopy time, lower radiation dose, and fewer access-site hematomas with this approach argue for its preferential use when possible and performed in an experienced centre.

Transradial versus transfemoral approach for percutaneous coronary intervention in cardiogenic shock: A radial-first centre experience and meta-analysis of published studies.

BACKGROUND: The transradial approach for percutaneous coronary intervention (PCI) is associated with a better outcome in myocardial infarction (MI), but patients with cardiogenic shock (CS) were excluded from most trials. AIMS: To compare outcomes of PCI for MI-related CS via the transradial versus transfemoral approach. METHODS: A prospective cohort of 101 consecutive patients admitted for PCI for MI-related CS were treated via the transradial (n=74) or transfemoral (n=27) approach. Cox proportional hazards models adjusted for prespecified variables and a propensity score for approach were used to compare mortality, death/MI/stroke and bleeding between the two groups. A complementary meta-analysis of six studies was also performed. RESULTS: Patients in the transradial group were younger (P=0.039), more often male (P=0.002) and had lower GRACE and CRUSADE scores (P=0.003 and 0.001, respectively) and rates of cardiac arrest before PCI (P=0.009) and mechanical ventilation (P=0.006). Rates of PCI success were similar. At a mean follow-up of 756 days, death occurred in 40 (54.1%) patients in the transradial group versus 22 (81.5%) in the transfemoral group (adjusted hazard ratio [HR]: 0.49, 95% confidence interval [CI] 0.28-0.84; P=0.012). The transradial approach was associated with reduced rates of death/MI/stroke (adjusted HR: 0.53, 95%CI: 0.31-0.91; P=0.02) and major bleeding (adjusted HR: 0.34, 95%CI: 0.13-0.87; P=0.02). The meta-analysis confirmed the benefit of transradial access in terms of mortality (relative risk [RR]: 0.63, 95%CI: 0.58-0.68) and major bleeding (RR: 0.43, 95%CI: 0.32-0.59). CONCLUSION: The transradial approach in the setting of PCI for ischaemic CS is associated with a dramatic reduction in mortality, ischaemic and bleeding events, and should be preferred to the transfemoral approach in radial expert centres.

Iatrogenic bidirectional dissection during transcatheter aortic valve implantation: a fatal complication.

Iatrogenic aortic or coronary dissections are well known complications in the field of interventional cardiology. They are the most dreadful situations, often with terrible consequences. We present herein a case of bidirectional dissection to the right coronary artery and to the ascending aorta during a transcatheter aortic valve implantation procedure.

Atrial septostomy in cardiogenic shock related to H1N1 infection.

The circulatory assistance, mainly the extra-corporeal membrane oxygenation (ECMO) restores hemodynamics and serves to limit the myocardial work, in order to avoid left ventricular dilation, high end-diastolic pressures, increased wall stress, subendocardial ischemia and consequently worsening pulmonary congestion and edema. In patients with large myocardial damage, sometimes an additional unloading of the left ventricle is warranted. We report a case of percutaneous blade and balloon atrial septostomy (BAS) as an add-on to the circulatory assistance to unload the left heart in a cardiogenic shock related to H1N1 infection.

Percutaneous blade and balloon atrioseptostomy as a supplement to extracorporeal membrane oxygenation as a bridge to heart transplantation.

In patients with severe ventricular dysfunction, the extracorporeal membrane oxygenation (ECMO) could be insufficient to discharge the left ventricle. The percutaneous blade and balloon atrioseptostomy that requires transeptal catheter-based experience could be an advisable technique to supplement assistance as a bridge to partial recovery or to heart transplantation. We present a case of a young male who presented for cardiogenic shock with a huge thrombus in the left main coronary artery in whom blade and balloon atrioseptostomy in addition to the ECMO was helpful to bail out and to perform heart transplantation.

Left main coronary artery transradial rescue percutaneous coronary intervention for acute myocardial infarction complicated by cardiogenic shock with Impella ventricular mechanical support.

Mechanical ventricular assist support and especially Impella device that is implanted via femoral access are considered a cornerstone in the therapeutic arsenal of the management of cardiogenic shock. Indeed, the potent antithrombotic agents administered during acute coronary syndromes constitute potential bleeding risk factors. Transradial interventions are nowadays widely used in ST-elevation myocardial infarction patients. However, some operators feel uncomfortable with the transradial approach when facing cardiogenic shock. We report a case of transradial rescue percutaneous intervention for cardiogenic shock in a young man with support of an Impella device via femoral access.

Spontaneous coronary artery dissection: one entity with several therapeutic options.

Spontaneous coronary artery dissection is an unusual and a rare cause of acute coronary syndrome and sudden death with multiple predisposing factors. Prompt recognition is crucial for appropriate patient management, but specific guidelines for optimal treatment are lacking. We report four cases of women with spontaneous coronary artery dissection revealed by ST-segment elevation, three in women during postpartum and one case associated with a Marfan syndrome. Our cases span the different therapeutic options from medical treatment, stenting, to coronary artery bypass graft surgery.

Procedural results and 30-day clinical events analysis following Edwards transcatheter aortic valve implantation in 48 consecutive patients: initial experience.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a rapidly evolving strategy for therapy of aortic stenosis. We presented the procedural results and analyzed the death causes of 30-day mortality and clinical events in patients who underwent TAVI with Edwards prosthetic valves in University Hospital of Caen, France. METHODS: The patients with severe aortic stenosis but at high surgical risk or inoperable were considered as candidates for TAVI. Forty-eight patients undergoing TAVI from July 2010 to September 2011 were enrolled in this registry. The Edwards prosthetic valves were solely used in this clinical trial. RESULTS: Overall 48 patients underwent TAVI, 28 of which accepted TAVI by trans-femoral (TF) approaches, 20 by trans-apical approaches (TA). The aortic valve area (AVA) was (0.70 ± 0.23) cm(2), left ventricular ejection fraction (LVEF) was (57.4 ± 17.6)%, Log EuroSCORE was (19.2 ± 15.8)%, mean gradient was (47.0 ± 16.6) mmHg. There were no significant differences between TF and TA groups in all these baseline parameters. Device success rate was 95.8%, and procedural success rate was 93.7% in total. Procedural mortality was 6.7% (3/48): two deaths in TA group (10%), and one death in TF group (3.6%). Forty-six Edwards valves were implanted: 10 Edwards Sapien and 36 Edwards XT. Procedure-related complications included cardiac tamponade in 2 cases (4.2%), acute myocardial infarction (AMI) in 1 case (2.1%), permanent pacemaker implantation in 1 case (2.1%), life-threatening and major bleeding in 3 cases; access site related major complication in 1 case, AKI stage 3 in 3 cases (6.3%), minor stroke in 1 case (2.1%). Thirty-day survival rate was 89.6%. There were 5 deaths in total (10.4%): 4 in TA group (20%) and 1 in TF group (3.6%). CONCLUSION: The procedural success rate and 30-day mortality were acceptable in these high risk patients with Edwards prosthetic valves in the first 48 TAVI.

Coronary-pulmonary fistulas involving all three major coronary arteries co-existing with myocardial infarction.

We report the case of a man who presented with acute anterior myocardial infarction and in whom the coronary angiogram showed tight stenosis of the left anterior descending coronary artery and the right coronary artery associated with substantial coronary-pulmonary fistulas involving all three major coronary arteries. We discuss the possible links between coronary artery fistulas and myocardial infarction.

Extra-corporeal life support, transradial thrombus aspiration and stenting, percutaneous blade and balloon atrioseptostomy, all as a bridge to heart transplantation to save one life.

In patients with cardiogenic shock, the Extra-Corporeal Life Support (ECLS) has been shown to be lives saving. But, in some situations, it proves inadequate for the discharge of the left heart. Several device-based techniques have been proposed to decompress the left side either surgically or percutaneously, each of them with the proper potential risks and complications. One technique, the percutaneous blade and balloon atrioseptostomy that requires transseptal catheter based experience and consists of creating an atrial septal defect (ASD) could be an elegant technique as an "add on" to the classic assistance making together a bridge to partial recovery or to heart transplantation. Herein, we present a case of an adult patient who presented with inaugural resistant cardiac arrest with a thrombotic occlusion of the left anterior descending artery (LAD) who required Extra-Corporeal Life Support, thrombus aspiration, stenting of the culprit lesion, and percutaneous blade and balloon atrioseptostomy to bridge "safely" to the heart transplantation.

Left main coronary stenting in a non surgical octogenarian population: a possible approach.

Coronary artery bypass grafting is conventionally considered the standard treatment for significant left main coronary artery (LMCA) disease. The management of LMCA disease in octogenarians is however still debated. The aim of this study was to appreciate the safety and effectiveness of percutaneous coronary intervention (PCI) for LMCA disease in octogenarians who were denied for surgical revascularization. The study included 70 consecutive patients ≥80 years of age who had undergone PCI for the treatment of LMCA and who were primary denied by our center's heart team for surgical revascularization. Mean age was 83.4±2.6 years. Mean Euroscore was 21.1±16.7 and mean Syntax score was 28.6±8.7. Overall in-hospital mortality was 11%. Mean follow-up time was 30.5±24.2 months. Overall mortality at the end of follow-up was 28%. Cardiac death was found in 18 patients and 2 patients died from terminal renal insufficiency. One patient (2%) presented with a new STEMI, 7 (11.3%) with a new non-STEMI, 13 (21%) with heart failure, and 2 (3.2%) had minor hemorrhage. There was a percutaneous target vessel revascularization in 6 (10%) patients. During follow-up, the total major adverse cerebral and cardiovascular event (MACCE including death, non-fatal acute myocardial infarction (AMI), target lesion revascularization (TLR), or stroke) was 27.4%. Stent implantation was relatively safely applied for the treatment of LMCA disease in octogenarians who were refused for surgery and who represented a high risk population. Despite a non-negligible rate of MACCE, the clinical long term outcome seems correct for this specific population with heavy basal status.