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ObjectivesTranscatheter aortic valve replacement (TAVR) is increasingly performed. Physically small Asians have smaller aortic root and peripheral vessel anatomy. The influence of gender of Asian patients undergoing TAVR is unknown and may affect outcomes. The aim of this study was to assess sex differences in Asian patients undergoing TAVR.MethodsPatients undergoing TAVR from eight countries were enrolled. In this retrospective analysis, we examined differences in characteristics, 30-day clinical outcomes and 1-year survival between female and male Asian patients.ResultsEight hundred and seventy-three patients (54.4% women) were included. Women were older, smaller and had less coronary artery and lung disease but tended to have higher logistic EuroSCOREs. Smaller prostheses were used more often in women. Major vascular complications occurred more frequently in women (5.5% vs 1.8%, pConclusionsAsian women had significantly smaller stature and anatomy with some differences in clinical profiles. Despite more frequent major vascular complications, women had similar 30-day stroke or mortality rates. Functional status improvement was significant and comparable between the sexes. Conduction disturbance and permanent pacemaker requirements were similar as was 1-year survival.

Objectives This study sought to evaluate the main baseline and procedural characteristics, management, and clinical outcomes of patients from a large cohort of patients undergoing transcatheter aortic valve implantation (TAVI) who suffered coronary obstruction (CO). Background Very little data exist on CO following TAVI. Methods This multicenter registry included 44 patients who suffered symptomatic CO following TAVI of 6,688 patients (0.66%). Pre-TAVI computed tomography data was available in 28 CO patients and in a control group of 345 patients (comparisons were performed including all patients and a cohort matched 1:1 by age, sex, previous coronary artery bypass graft, transcatheter valve type, and size). Results Baseline and procedural variables associated with CO were older age (p Conclusions Symptomatic CO following TAVI was a rare but life-threatening complication that occurred more frequently in women, in patients receiving a balloon-expandable valve, and in those with a previous surgical bioprosthesis. Lower-lying coronary ostium and shallow sinus of Valsalva were associated anatomic factors, and despite successful treatment, acute and late mortality remained very high, highlighting the importance of anticipating and preventing the occurrence of this complication.

AIMS To assess the safety and efficacy of a novel sheathless (SH) 6.5 Fr (French) hydrophilic-coated guiding catheter (GC) compared to the standard 5 Fr GCs in transradial coronary interventions (TRI). METHODS AND RESULTS Patients undergoing TRI with 6.5 Fr SH or 5 Fr GCs were included. Baseline characteristics and in-hospital outcomes were recorded. Primary endpoints were procedural success and presence of radial pulse at discharge. Secondary endpoints were successful GC support, in-hospital adverse events, access-site complications, procedural duration and contrast load. There were 269 patients with 146 procedures in each group. The SH GC group had more non-ST elevation MI, in-stent restenosis, high-risk and bifurcation lesions. Procedural success in both arms was 95.2%. One patient in each group (0.7%) experienced radial artery occlusion (RAO) after TRI, without clinical sequelae. One access-site haematoma and one minor stroke occurred in the 5 Fr group (none in the SH group, both p=ns). Mean procedure time (52±21 vs. 45±21 minutes, p=0.004) and contrast load (160±45 ml vs. 140±45 ml, p=0.003) were greater in the SH group. CONCLUSIONS Both 6.5 Fr SH GCs and 5 Fr GCs achieved high procedural TRI success with low RAO rates. The SH GC eliminated the disadvantages of the 5 Fr GC whilst maintaining the advantage of low RAO rates, and may become the GC of choice in TRI.

Surgical treatment of mitral regurgitation (MR) has evolved from mitral valve replacement (MVR) to repair (MVR(e)), because MVR(e) produces superior long-term outcomes. In addition, MVR(e) can be achieved through minimally invasive approaches. This desire for less invasive approaches coupled with the fact that a significant proportion of patients--especially elderly persons or those with significant comorbidities or severe left ventricular (LV) dysfunction, are not referred for surgery, has driven the field of percutaneous MVR(e). Various technologies have emerged and are at different stages of investigation. A classification of percutaneous MVR(e) technologies on the basis of functional anatomy is proposed that groups the devices into those targeting the leaflets (percutaneous leaflet plication, percutaneous leaflet coaptation, percutaneous leaflet ablation), the annulus (indirect: coronary sinus approach or an asymmetrical approach; direct: true percutaneous or a hybrid approach), the chordae (percutaneous chordal implantation), or the LV (percutaneous LV remodeling). The percutaneous edge-to-edge repair technology has been shown to be noninferior to open repair in a randomized clinical trial (EVEREST II [Endovascular Valve Edge-to-Edge REpair Study]). Several other technologies employing the concepts of direct and indirect annuloplasty and LV remodeling have achieved first-in-man results. Most likely a combination of these technologies will be required for satisfactory MVR(e). However, MVR(e) is not possible for many patients, and MVR will be required. Surgical MVR is the standard of care in such patients, although percutaneous options are under development.

BACKGROUND A 49-year-old female presented with worsening exertional dyspnea (NYHA class III) and orthopnea for several months. Previous medical history was significant for rheumatic mitral regurgitation and three previous mitral valve replacements (MVRs). INVESTIGATION Transesophageal echocardiography (TEE) revealed severe mitral paravalvular leak (PVL with two jets visualised. Cardiac computed tomography angiography (CTA) revealed a larger PVL and a smaller defect. DIAGNOSIS Severe mitral paravalvular leak. TREATMENT Transcatheter mitral paravalvular closure.

Background— It has been demonstrated recently that carotid stenting can be performed safely in patients ≥80 years of age. However, it is uncertain whether these patients will derive benefit because longevity after revascularization is an important consideration. This study was conducted to determine survival and predictors of mortality of selected elderly patients after stenting. Methods and Results— One hundred forty-two consecutive elderly patients who were non–high risk for stenting underwent 153 procedures. Patients had either symptomatic stenosis ≥50% or asymptomatic stenosis ≥70%. Demographics and in-hospital outcomes were entered into a database; subsequent outcomes and mortality data were obtained retrospectively. Mean±SD age was 83.3±3.1 years. Symptomatic patients accounted for 28%. Overall survival at 3 years was 76% (85% at 2 years). At 1 year, 1 fatal stroke had occurred, with 97% of survivors (n=114) free of neurological events (neurological status was undetermined in the remaining 3%). Predictors of mortality were remote (≥6 months) transient ischemic attack or cerebrovascular accident, smoking history, and creatinine clearance (hemoglobin level showed a strong trend toward achieving significance); for the asymptomatic subgroup, predictors of mortality were smoking history, previous carotid endarterectomy, hemoglobin level, and increasing age. In particular, symptom status and sex were not independent predictors of mortality. Conclusions— This study demonstrates that in selected elderly patients, a high proportion (85%) survived 2 years and >75% survived 3 years after stenting. Carotid stenting may be considered a revascularization option in such patients. Better selection of patients using the predictors of mortality may help to reduce unwarranted procedures and to optimize survival likelihood.

Aortic valve stenosis is increasing in frequency as the population ages. Surgical aortic valve replacement is the gold standard for symptomatic patients with severe aortic valve stenosis. However, in a subset of high-risk patients, the surgical option is excluded due to severe comorbidities. Recently, an alternative to surgical aortic valve replacement--percutaneous aortic valve replacement (PAVR)--has emerged. Since the first PAVR in a human in 2002, the percutaneous heart valves (PHVs) have already undergone several modifications from first generation devices. Currently, there are 2 PHVs in clinical application, a balloon-expandable and a self-expandable PHV, with several others achieving first-in-man application. With the extremely rapid technological advancements, PAVR is probably here to stay. The next steps required would be to formulate goals to assess results and outcomes of PAVR, and plan trials to test their clinical applicability. This article discusses how best to assess results and outcomes, which may require a paradigm shift in mindset. Apart from the randomized controlled trial, some of the more novel concepts in trial design, which may be more suitable in this area, are also explored.

Objectives: This study evaluated the feasibility of percutaneous patent foramen ovale (PFO) closure using a transcatheter suture (Superstitch), leaving no device behind. Background: PFO has been implicated in cryptogenic strokes and migraine with auras. Percutaneous PFO closure, being less invasive than surgical closure, is increasingly performed. There are, however, early and long-term risks including device embolization, fracture, thrombosis, or infection, erosions into the free atrial wall and aorta, arrhythmias, and death. Furthermore, device implantation may complicate future percutaneous access to the left atrium. Partially reabsorbable devices and tissue welding to close PFO have recently been introduced. The first-in-man transcatheter suture closure of a PFO in an 18-year-old female with chronic migraine with aura and a well documented stroke is described. Methods: The right femoral vein was cannulated under mild sedation and local anesthesia. Using intracardiac echocardiography imaging, bubble study demonstrated a right-to-left shunt through the PFO at rest. A Superstitch device was advanced across the PFO and sutures were delivered through the septum primum and secundum. The sutures were exteriorized and a knot was advanced to the right atrial septum and cut. Results: Bubble study confirmed successful PFO suture closure. Transesophageal and transthoracic echocardiograms with bubble studies at 1 and 2 months, respectively showed complete closure with no right-to-left shunt even during Valsalva maneuver. At 6 months, the patient remained free ofsymptoms or migraine episodes. Conclusion: Percutaneous transcatheter suture closure of a PFO can be successfully achieved with no residual shunt and leaving nodevice behind. Technological refinements are required for wider scale use. © 2008 Wiley-Liss, Inc.

Objective We sought to evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve (BiAV). Background BiAV remains a relative contraindication to TAVI resulting in exclusion from TAVI trials and thus limiting data on the clinical performance of transcatheter valves in these patients. Methodology We conducted an international patient level multicenter analysis on outcomes in patients with BiAV undergoing TAVI. The primary outcome of the study was the combined early safety endpoint — a composite of 30day mortality, stroke, life-threatening bleeding, acute kidney injury, coronary artery obstruction, major vascular complication and valve related dysfunction. Secondary endpoints included the individual components of the primary endpoint as well as post-TAVI paravalvular leak (PVL), rehospitalization, new pacemaker insertion and device success rates at 30days and 1year. Results A total of 108 patients with BiAV were identified in 21 centers in Canada, Spain, Italy, Poland and Singapore who underwent TAVI between January 2005 and March 2014. The composite primary outcome occurred in one quarter of patients (26.9%) — mainly driven by re-intervention for valve malposition (9.3%). The 30-day and 1year mortality rates were 8.3% and 16.9% respectively with AR≥3+ occurring in 9.6% of patients. Device success was achieved in 85.2% of cases with pacemaker insertion in 19.4%. While PVL was not associated with an increased risk of 30day or 1year mortality — Type I BiAV anatomy with left and right cusp fusion had significantly better outcomes than other valve variants. Conclusion In selected patients with BiAV and severe aortic stenosis, TAVI appears both safe and feasible with acceptable clinical outcomes. Clinical studies of TAVI in this patient population are warranted.

The prevalence of aortic valve stenosis (AS) increases with advancing age, and the condition is present in 4.6% of adults ≥ 75 years of age.1

A 56-year-old female with systemic lupus erythematosus (SLE) and antiphospholipid syndrome, with severe aortic stenosis (mean gradient 50 mmHg, valve area 0.7 cm2) was referred for transcatheter aortic valve implantation (TAVI), due to multiple comorbidities including severe thrombocytopenia, long-term steroids, and tracheostomy for upper airway obstruction. Although transoesophageal echocardiography showed a severely thickened aortic valve ( Panel A , …

Aortic valve stenosis (AS) will become more common as the population ages. Once symptoms occur, the prognosis is poor. Aortic valve replacement (AVR) has been the standard of care, improving symptoms and prolonging survival. A significant proportion of patients, however, do not undergo AVR due to increased surgical-risk. The technology of transcatheter aortic valve implantation (TAVI) emerged in 2002 and offered some of these patients an alternative therapy. A randomised (PARTNER) trial has shown that TAVI (using the Edwards-Sapien transcatheter heart valve) was superior to medical therapy (including balloon aortic valvuloplasty) in inoperable patients with a significant reduction in all-cause mortality at one year. For high surgical-risk patients, TAVI demonstrated non-inferiority to open AVR, with similar all-cause mortality at one year. Currently two devices, the Edwards-Sapien and the CoreValve transcatheter heart valves, are in clinical use and are undergoing further trials. Device improvements will be required to enhance procedural success and safety and longer term data would be required to understand the longevity of these valves. Further trial data would be required to compare TAVI and open AVR in moderate surgical-risk patients if this technology were to become a more common therapy.

A 77-year-old man presented with increasingly symptomatic severe aortic stenosis (AS). Echocardiogram showed an aortic valve area of 0.6 cm2 and a mean pressure gradient of 57 mm Hg. It could not be ascertained conclusively if the valve was tricuspid or bicuspid due to heavy calcification ([Figs. 1

Objectives: This study was conducted to report the clinical, hemodynamic, and iconographic outcomes of the longest survivor of the global CoreValve experience. Background: Early results of percutaneous heart valve (PHV) implantation for severe symptomatic aortic stenosis (AS) have been encouraging, with mid term survival up to 2 years; however longer durability term is unknown. Although a PHV has been implanted in a degenerated surgical bioprosthesis, the feasibility of a PHV-in-PHV has not been demonstrated. Methods: A patient with severe refractory heart failure due to severe aortic regurgitation (AR) and moderate AS, underwent CoreValve prosthesis implantation. The PHV was deployed too proximal into the left ventricular outflow tract, resulting in severe AR through the frame struts. Using the first PHV as a landmark, a second CoreValve was then deployed slightly distal to the first, with trivial residual paravalvular leak. Results: The second CoreValve expanded well with proper function. Transvalvular gradient was 8 mmHg. Both coronary ostia were patent. New mild to moderate mitral regurgitation occurred due to impingement of the anterior mitral leaflet by the first PHV. NYHA functional class improved from IV to II, maintained over the past 3 years. Echocardiography at 3 years showed normal functioning CoreValve-in-CoreValve prostheses, without AR or paravalvular leaks. Transvalvular gradient was 10 mmHg. Cardiac CT showed stable valve-in-valve protheses with no migration. Conclusion: The CoreValve prosthesis has maintained proper function up to 3 years, with no structural deterioration or migration. Treating mixed aortic valve disease with predominant AR is feasible. The concept as well as durability of the first PHV-in-PHV has also been demonstrated. © 2008 Wiley-Liss, Inc.

Aortic stenosis (AS) is currently the most common valvular abnormality in developed countries. The gold standard treatment of severe symptomatic AS is surgical aortic valve replacement. Mechanical valves were initially the prostheses of choice; with improvement of surgical technique and results, and increased durability of bioprosthetic valves, there has been a trend toward increasing use of bioprostheses. Concurrently, percutaneous technology has advanced exponentially, and the first human percutaneous aortic valve replacement (PAVR) became a reality in 2002. Various groups have now reported their early experiences with PAVR using different technologies. This new treatment modality is evolving very rapidly. There are currently 2 devices being used in clinical trials; several more devices have first-in-man results and others in preclinical development. It appears that PAVR will most likely become a viable option for selected patients in the near future. For these technologies to continue to improve and benefit patients, cross-specialty teamwork is vital. Treatment of severe AS will greatly evolve as these new and emerging technologies improve. Enhancement in device designs and increasing operator experience will make this technology safer and allow its application to a wider patient population.

Sheath placement prior to carotid artery stenting is usually uncomplicated, and provides sufficient support for the procedure. In certain patients, especially those with unfavorable arch anatomy, tortuous vessels, and heavily calcified lesions, the sheath backs out into the aortic arch with compromise of wire and embolic protection device (EPD) position, and risk of “dragging” the EPD back through the lesion. A novel use of the distal filter retrieval catheter to “rescue” a prolapsed guide sheath is described. Use of the filter retrieval catheter as a “body” to retrack the sheath but not recapturing the deployed filter is a useful technique, since the equipment is already available. This avoided the need to pull a retrieved filter through a severe undilated carotid stenosis, reducing the amount of manipulations needed to reposition the sheath and thus reducing the risk of embolic events. © 2008 Wiley-Liss, Inc.

Transradial coronary intervention (TRI) is increasingly performed, with the standard 6 French (Fr) guiding catheters (GC) employed by most operators. However, based on the radial artery size, only up to 72% of female and 85% of male Asian patients can physically accept the 6 Fr sheath. The 5 Fr GC

Transcatheter aortic valve implantation (TAVI) has emerged as a viable alternative endovascular technique in selected patients with severe aortic stenosis, who are either inoperable or at high risk for surgical aortic valve replacement. We report a case of delayed displacement and rotation of an aortic bioprosthesis, 43 days after successful TAVI via the transfemoral approach, with the patient surviving the subsequent open heart surgery required for device retrieval.

Objectives The purpose of this study was to evaluate the feasibility and efficacy of the percutaneous device closure of a consecutive series of patients with periprosthetic paravalvular leaks referred to our structural heart disease center with congestive heart failure and hemolytic anemia. Background Clinically significant periprosthetic paravalvular leak is an uncommon but serious complication after surgical valve replacement. Percutaneous closure has been utilized as an alternative to surgical repair of this defect in high-risk surgical patients. Methods This is a retrospective review of 57 percutaneous paravalvular leak closures that were performed in 43 patients (67% male, mean age 69.4 ± 11.7 years) between April 2006 and September 2010. Integrated imaging modalities were used for the evaluation, planning, and guidance of the interventions. Results Closure was successful in 86% of leaks and in 86% of patients. Twenty-eight of 35 patients improved by at least 1 New York Heart Association functional class. The percentage of patients requiring blood transfusions and/or erythropoietin injections post-procedure decreased from 56% to 5%. Clinical success was achieved in 89% of the patients in whom procedure was successful. The survival rates for patients at 6, 12, and 18 months after paravalvular leak closures were 91.9%, 89.2%, and 86.5%, respectively. Freedom from cardiac-related death at 42 months post-procedure was 91.9%. Conclusions Percutaneous closure of symptomatic paravalvular leaks, facilitated by integrated imaging modalities has a high rate of acute and long-term success and appears to be effective in managing symptoms of heart failure and hemolytic anemia.