Sex differences in patients undergoing transcatheter aortic valve replacement in Asia.

OBJECTIVES: Transcatheter 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. METHODS: Patients 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. RESULTS: Eight 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%, p<0.01); however, 30-day stroke and mortality (women vs men: 1.5% vs 1.6%, p=0.95% and 4.3% vs 3.4%, p=0.48) were similar. Functional status improvement was significant and comparable between the sexes. Conduction disturbance and permanent pacemaker requirements (11.2% vs 9.0%, p=0.52) were also similar as was 1-year survival (women vs men: 85.6% vs 88.2%, p=0.25). The only predictors of 30-day mortality were major vascular injury in women and age in men. CONCLUSIONS: Asian 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.

One-year clinical outcomes, midterm survival, and predictors of mortality after carotid stenting in elderly patients.

BACKGROUND: It has been demonstrated recently that carotid stenting can be performed safely in patients > or =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 > or =50% or asymptomatic stenosis > or =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 (> or =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.

Percutaneous transcatheter aortic valve implantation: Evolution of the technology.

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.

Retrograde angioplasty for basilar artery stenosis: bypassing bilateral vertebral artery occlusions.

Basilar artery angioplasty with or without stenting is an emerging and promising treatment for vertebrobasilar insufficiency that is refractory to medical therapy. The usual approach is via a transfemoral route, with access directly through the vertebral artery (VA). An approach from the anterior circulation via the posterior communicating artery has been reported for optimal stent positioning and deployment across basilar apex aneurysms. No similar technique has been reported for treatment of midbasilar stenosis. The authors report a case of severe symptomatic basilar stenosis in which both VAs were occluded. The only option was to perform retrograde basilar angioplasty via the posterior communicating artery. This useful technique should be part of the armamentarium for the percutaneous treatment of symptomatic vertebrobasilar insufficiency for the occasional patient in whom occlusion or tortuosity precludes direct access to the VA.

Carotid sheath rescue with a distal filter retrieval catheter.

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.

The parallel wire technique for septal defect closure.

Percutaneous closure of sedundum atrial septal defects (ASD) has been shown to be safe and effective. Usually crossing the defect is relatively straightforward. Occasionally, with fenestrated ASDs, trying to cross the defect(s) may be challenging. We report the use of a "paralle wire" (0.018 or 0.014 inch wire) technique to maintain access and be able to recross the same defect easily in case of misplacement until just before the device was secured and released. This technique could be used also as a "body wire" for large ASDs with deficient rims to reduce the incidence of device prolapse, and for patent foramen ovale and ventricular septal defect closures. This is a simple and easily reproducible method with the equipment readily available in virtually all catheterization laboratories.

Feasibility of patent foramen ovale closure with no-device left behind: first-in-man percutaneous suture closure.

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 of symptoms or migraine episodes. CONCLUSION: Percutaneous transcatheter suture closure of a PFO can be successfully achieved with no residual shunt and leaving no device behind. Technological refinements are required for wider scale use.

First percutaneous transcatheter aortic valve-in-valve implant with three year follow-up.

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.

Carotid artery stenting in elderly patients: importance of case selection.

OBJECTIVES: This study was conducted to determine if carotid stenting (CS) could be safely performed in the elderly. BACKGROUND: Age has been shown to be a predictor of neurological complications during CS. We postulated that CS could be safely performed in elderly patients if certain anatomical and clinical markers such as excessive vascular tortuosity, heavy concentric calcification of the lesion, and decreased cerebral reserve were avoided. METHODS: From July 2003 to October 2007, 142 patients aged > or =50% or asymptomatic stenosis > or =70%. All patients underwent carotid and cerebral angiography to determine anatomic suitability and stent risk. Demographic and outcome data were entered into a database; other data were obtained retrospectively. Independent neurology evaluation was performed before and at 24 hr after the procedure. RESULTS: The mean age was 83.2 years, 62% were male, 25.5% were symptomatic, 8.5% had postcarotid endarterectomy restenosis, and 6.0% had contralateral internal carotid artery occlusion. There were no intracranial hemorrhages or periprocedural myocardial infarctions. One patient had amaurosis fugax. There were two minor and three major strokes in-hospital (3.3%). All patients had 30-day follow-up. One of the major strokes expired. Thus the overall 30-day stroke or death rate was 3.3% and major stroke or death rate was 2.0%. The 30-day stroke or death rate was 5.1% for symptomatic patients and 2.6% for asymptomatic patients. CONCLUSION: CS can be performed safely in anatomically suitable elderly patients with low adverse event rates. CS should remain a revascularization option in appropriately selected elderly patients.

Quantified degree of eccentricity of aortic valve calcification predicts risk of paravalvular regurgitation and response to balloon post-dilation after self-expandable transcatheter aortic valve replacement.

BACKGROUND: Limited data exist regarding the impact of aortic valve calcification (AVC) eccentricity on the risk of paravalvular regurgitation (PVR) and response to balloon post-dilation (BPD) after transcatheter aortic valve replacement (TAVR). We investigated the prognostic value of AVC eccentricity in predicting the risk of PVR and response to BPD in patients undergoing TAVR. METHODS: We analyzed 85 patients with severe aortic stenosis who underwent self-expandable TAVR (43 women; 77.2±7.1years). AVC was quantified as the total amount of calcification (total AVC load) and as the eccentricity of calcium (EoC) using calcium volume scoring with contrast computed tomography angiography (CTA). The EoC was defined as the maximum absolute difference in calcium volume scores between 2 adjacent sectors (bi-partition method) or between sectors based on leaflets (leaflet-based method). RESULTS: Total AVC load and bi-partition EoC, but not leaflet-based EoC, were significant predictors for the occurrence of ≥moderate PVR, and bi-partition EoC had a better predictive value than total AVC load (area under the curve [AUC]=0.863 versus 0.760, p for difference=0.006). In multivariate analysis, bi-partition EoC was an independent predictor for the risk of ≥moderate PVR regardless of perimeter oversizing index. The greater bi-partition EoC was the only significant parameter to predict poor response to BPD (AUC=0.775, p=0.004). CONCLUSION: Pre-procedural assessment of AVC eccentricity using CTA as "bi-partition EoC" provides useful predictive information on the risk of significant PVR and response to BPD in patients undergoing TAVR with self-expandable valves.

The expanding indications of transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI), also known as transcatheter aortic valve replacement, is increasingly performed worldwide and is a technology that is here to stay. It has become the treatment of choice for inoperable patients and an alternative option for patients at high surgical risk with severe aortic stenosis. Early results of TAVI in intermediate-risk patients appear promising although larger randomized trial results are awaited before the widespread adoption of this technology in this big pool of patients. In patients with bicuspid aortic stenosis and degenerated surgical bioprostheses, TAVI has been shown to be feasible and relatively safe, though certain important considerations remain. Indications for TAVI are likely to grow as newer generation and improved devices and delivery systems become available.

Transcatheter aortic valve implantation in patients with bicuspid aortic valve: A patient level multi-center analysis.

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 30 day 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 30 days and 1 year. 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 1 year 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 30 day or 1 year 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.