A Bicuspid Aortic Valve Imaging Classification for the TAVR Era.

OBJECTIVES: This study sought to evaluate transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) aortic stenosis (AS), with a particular emphasis on TAVR-directed bicuspid aortic valve imaging (BAVi) of morphological classification. BACKGROUND: TAVR has been used to treat BAV-AS but with heterogeneous outcomes and uncertainty regarding the relevance of morphology. METHODS: In 14 centers in the United States, Canada, Europe, and Asia, 130 BAV-AS patients underwent TAVR. Baseline cardiac computed tomography (CT) was analyzed by a dedicated Corelab. Outcomes were assessed in line with Valve Academic Research Consortium criteria. RESULTS: Bicommissural BAV (vs. tricommissural) accounted for 68.9% of those treated in North America, 88.9% in Europe, and 95.5% in Asia (p = 0.003). For bicommissural bicuspids, non-raphe type (vs. raphe type) BAV accounted for 11.9% of those treated in North America, 9.4% in Europe, and 61.9% in Asia (p < 0.001). Overall rates of 30-day mortality (3.8%) and cerebrovascular events (3.2%) were favorable and similar among anatomical subsets. The rate of new permanent pacemaker insertion was high (26.2%) and similar between balloon-expandable (BE) and self-expanding (SE) designs (BE: 25.5% vs. SE: 26.9%; p = 0.83); there was a trend to greater permanent pacemaker insertion in BE TAVR in the presence of coronary cusp fusion BAV morphology. Paravalvular aortic regurgitation (PAR) ≥ moderate was 18.1% overall but lower at 11.5% in those with pre-procedural CT. In the absence of pre-procedural CT, there was an excess of PAR in BE TAVR that was not the case in those with a pre-procedural CT; SE TAVR required more post-dilation. Predictors of PAR included intercommissural distance for bicommissural bicuspids (odd ratio [OR]: 1.37; 95% confidence interval [CI]: 1.02 to 1.84; p = 0.036) and lack of a baseline CT for annular measurement (OR: 3.03; 95% CI: 1.20 to 7.69; p = 0.018). CONCLUSIONS: In this multicenter study, TAVR achieved favorable outcomes in patients with pre-procedural CT, with the exception of high permanent pacemaker rates for all devices and shapes.

Is it time to simplify the TAVI procedure? "Make it simple but not too simple".

As transcatheter aortic valve implantation (TAVI) becomes a standardised procedure with reproducible and excellent periprocedural, early and medium-term outcomes, it is opportune to question whether the time has come to simplify the TAVI procedure. In some centres, a minimalist approach to TAVI is already the standard of care. In this perspective, we share our experience and opinions on how and when we can simplify the TAVI procedure.

CRosser As First choice for crossing Totally occluded coronary arteries (CRAFT Registry): focus on conventional angiography and computed tomography angiography predictors of success.

AIMS: We investigated the use of the CROSSER catheter, a CTO crossing device based upon high frequency mechanical vibration, as a first resort to treat patients with chronic total occlusions (CTO) while describing angiographic and computed tomography coronary angiography (CTCA) serving as predictors for success. METHODS AND RESULTS: Eighty consecutive patients were enrolled in this prospective multicentre registry of patients treated for a CTO. For 76.3% of the patients, this was the first attempt to open the CTO. Overall success rate was 75%. By conventional coronary angiography, the length of the occlusion was 26.7±14.1 mm and there was a difference in successful vs. unsuccessful cases (24.5±13.9 and 32.8±13.1, p=0.02). The presence of angulation, as defined qualitatively, was more prevalent in failed cases (60.0% vs. 32.2%, p=0.03). The mean ratio CROSSER distance within the occlusion site and length of the occlusion showed a trend towards statistical significance in successful procedures (0.56±0.90 vs. 0.30±0.34, p=0.08). During hospitalisation, two patients had a non-fatal myocardial infarction. One patient experienced delayed onset of tamponade six hours postprocedure. At 30 days, two patients had PCI in a non-treated vessel and one patient had a transient ischaemic attack. Relation to the CROSSER catheter was inconclusive. CONCLUSIONS: The success rate of the use of a dedicated-CTO device--the CROSSER catheter--as a first choice to open a chronic total occlusion was 75%. By multivariate analysis, in a subset of patients that were imaged with computed tomography coronary angiography, the absence of angulation was related with higher success rate.

Outcomes after transcatheter aortic valve implantation with both Edwards-SAPIEN and CoreValve devices in a single center: the Milan experience.

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.

Emerging approaches of transcatheter valve repair/insertion.

Aortic stenosis (AS) and mitral regurgitation (MR) account for the majority of valvular diseases and their prevalence is increasing according to increased life expectancy. Surgical treatment is the gold standard, although operative risk may be high in some patients due to comorbidities and age. A large part of the patients at high surgical risk who could beneficiate of treatment are not referred to surgery. Therefore, there is a need of alternative and less invasive procedures.

Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve.

BACKGROUND: Transcatheter aortic valve implantation was developed to mitigate the mortality and morbidity associated with high-risk traditional aortic valve replacement. The Edwards SAPIEN valve was approved for transcatheter aortic valve implantation transfemoral delivery in the European Union in November 2007 and for transapical delivery in January 2008. METHODS AND RESULTS: The SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry was designed to assess the initial clinical results of the Edwards SAPIEN valve in consecutive patients in Europe after commercialization. Cohort 1 consists of 1038 patients enrolled at 32 centers. Patients who were treated with the transapical approach (n=575) suffered more comorbidities than the transfemoral patients (n=463), resulting in a significantly higher logistic EuroSCORE (29.1% versus 25.7%; P<0.001). Therefore, these groups are considered different, and outcomes cannot be compared. Overall short-term procedural success was observed in 93.8%. The incidence of valve embolization was 0.3% (n=3), and coronary obstruction was reported for 0.6% (n=6 cases). Incidence of stroke was 2.5% and similar for both procedural approaches. Thirty-day mortality was 6.3% in transfemoral patients and 10.3% in transapical patients. The occurrence of vascular complications was not a predictor of <30-day mortality in the transfemoral population. CONCLUSIONS: Technical proficiency can be learned and adapted readily as demonstrated by the short-term procedural success rate and low 30-day mortality rates reported in the SOURCE Registry. Specific complication management and refinement of patient selection are needed to further improve outcomes.

Comparison of the long-term safety and efficacy of drug-eluting and bare-metal stent implantation in saphenous vein grafts.

BACKGROUND: Concerns about the long-term safety of drug-eluting stents (DES) in saphenous vein grafts has become an area of controversy and uncertainty. METHODS AND RESULTS: In this retrospective registry, we compared the outcomes in 127 patients (143 lesions) treated with DES from April 2002 to June 2006 (DES group) with 131 patients (160 lesions) treated with bare-metal stents in the preceding 36 months (bare-metal stent group). End points analyzed were cumulative death, myocardial infarction, and target vessel revascularization at 2 years after stent implantation. The DES group was significantly (P<0.05) more complex with a greater frequency of diabetes (33.1%versus 15.3%), older grafts (11.6+/-5.3 years versus 9.6+/-5.2 years), restenotic lesions (23.8% versus 4.4%), total occlusions (7.7% versus 1.2%), and smaller grafts (3.16+/-0.66 mm versus 3.44+/-0.76 mm) treated with longer stents (34.1+/-25.1 mm versus 22.7+/-11.6 mm). At 2 years, there was no statistical difference in death (8.7% versus 7.8%), myocardial infarction (6.3% versus 9.4%), or target vessel revascularization (19.7% versus 24.2%) between DES and bare-metal stents, respectively. A propensity analysis to adjust for baseline differences suggested that there was no observed association between DES and increased mortality (hazard ratio, 0.72; 95% CI, 0.21 to 2.44; P=0.60) but possibly an association with a reduction in target vessel revascularization (hazard ratio, 0.31; 95% CI, 0.14 to 0.66; P=0.002). CONCLUSIONS: Despite being implanted in patients and lesions more complex than the bare-metal stent group, there was no observed association between DES implantation in saphenous vein grafts and an increase in late mortality. DES may maintain their efficacy in reducing revascularization rates in diseased saphenous vein grafts over a 2-year follow-up period.

Percutaneous transcatheter aortic valve implantation: past accomplishments, present achievements and applications, future perspectives.

Surgical aortic valve replacement remains the gold standard for the treatment of severe, symptomatic aortic stenosis. However, percutaneous treatments are challenging this paradigm in high-risk surgical patients. Technological developments have been rapid in the field of percutaneous aortic valve intervention. Two devices have been approved for general use in Europe: the Edwards SAPIEN valve (Edwards Lifesciences, Irvine, CA) and the CoreValve ReValving((R)) System (CoreValve ReValving((R)) Technology Medtronic Inc., Minneapolis, MN), with 15 potential new designs for percutaneous aortic valves in development around the world. Both systems can be delivered via the transfemoral, transapical and the axillary/subclavian routes, depending upon patient characteristics, anatomy, and the device available to the operator. Careful selection of appropriate patients is essential to ensure a safe procedure. This necessitates a multidisciplinary approach, with multiple imaging modalities used to fully delineate the peripheral vasculature, aortic anatomy and the valve itself. It is important to remember, however, that just because we can treat aortic valve disease percutaneously, it does not mean that we necessarily should. The gold standard treatment for aortic stenosis remains thoracotomy and surgical replacement of the valve; to this end it is essential that surgeons play a central role in the decision-making processes for transcatheter aortic valve implantation and that they embrace this new and exciting technology, which promises to dramatically change the way their high-risk aortic valve patients are managed over the course of the next 10 years.

Percutaneous mitral valve repair with the MitraClip system: acute results from a real world setting.

AIMS: This study sought to evaluate the feasibility and early outcomes of a percutaneous edge-to-edge repair approach for mitral valve regurgitation with the MitraClip system (Evalve, Inc., Menlo Park, CA, USA). METHODS AND RESULTS PATIENTS: were selected for the procedure based on the consensus of a multidisciplinary team. The primary efficacy endpoint was acute device success defined as clip placement with reduction of mitral regurgitation to < or =2+. The primary acute safety endpoint was 30-day freedom from major adverse events, defined as the composite of death, myocardial infarction, non-elective cardiac surgery for adverse events, renal failure, transfusion of >2 units of blood, ventilation for >48 h, deep wound infection, septicaemia, and new onset of atrial fibrillation. Thirty-one patients (median age 71, male 81%) were treated between August 2008 and July 2009. Eighteen patients (58%) presented with functional disease and 13 patients (42%) presented with organic degenerative disease. A clip was successfully implanted in 19 patients (61%) and two clips in 12 patients (39%). The median device implantation time was 80 min. At 30 days, there was an intra-procedural cardiac tamponade and a non-cardiac death, resulting in a primary safety endpoint of 93.6% [95% confidence interval (CI) 77.2-98.9]. Acute device success was observed in 96.8% of patients (95% CI 81.5-99.8). Compared with baseline, left ventricular diameters, diastolic left ventricular volume, diastolic annular septal-lateral dimension, and mitral valve area significantly diminished at 30 days. CONCLUSION: Our initial results with the MitraClip device in a very small number of patients indicate that percutaneous edge-to-edge mitral valve repair is feasible and may be accomplished with favourable short-term safety and efficacy results.

First trans-axillary implantation of Edwards Sapien valve to treat an incompetent aortic bioprosthesis.

There exist case reports of using transcatheter aortic valves to treat dysfunctional surgically implanted aortic bioprosthesis. There are also case series reported of transaxillary implantation of the CoreValve device to treat aortic stenosis. In this article, we report the successful implantation an Edwards Sapien 23 mm transcatheter aortic valve through the left axillary artery, in a patient with a functioning LIMA graft in order to treat a severely regurgitant Freestyle 23 mm aortic bioprosthesis.

A new technique for vascular access management in transcatheter aortic valve implantation.

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.

Percutaneous mitral valve repair with the edge-to-edge technique.

Percutaneous treatment of mitral valve regurgitation with the MitraClip™ system is emerging as an alternative to surgery in high-risk and inoperable patients. The device is designed to bond the opposing leaflets at the site of regurgitation, reproducing the results of the Alfieri technique in a beating heart approach. We describe the selection criteria and the procedural steps of the procedure, which is performed under general anesthesia and guided by trans-esophageal echocardiography, using a sophisticated delivery system to deliver the clip at the desired target. We also briefly report the currently available data which supports the application of this therapy in selected patients with either degenerative or functional mitral regurgitation.

Histopathology of clinical coronary restenosis in drug-eluting versus bare metal stents.

To characterize in-stent restenosis after the implantation of sirolimus-eluting stents (SES), paclitaxel-eluting stents (PES), tacrolimus-eluting stents (TES), and zotarolimus-eluting stents (ZES), 25 patients treated with drug-eluting stents (DES; 9 PES, 10 SES, 4 TES, and 2 ZES) and 19 with bare-metal stents (BMS) underwent directional coronary atherectomy for in-stent restenosis 4 to 36 months after implantation. Restenosis after DES implantation was more frequently focal and associated with smaller specimens compared to that after BMS implantation. Light and confocal microscopy were used. Histologic features were similar in DES and BMS. In-stent restenotic lesions were composed mainly of neointima containing proteoglycan-rich smooth muscle cells and fibrolipidic regions. Small inflammatory infiltrates were observed, mostly in patients with unstable angina; CD18- and/or CD3(+) cells were detected in patients with BMS and DES. Different smooth muscle cell phenotypes were observed: synthetic was more frequent with BMS and PES, intermediate with ZES, contractile or intermediate with SES, and contractile with TES. The mean proliferation index was low and comparable among stent types; cyclins B1 and D1 were expressed in all DES. In conclusion, intra-DES and intra-BMS restenotic tissue was composed mainly of smooth muscle cells with different phenotypes, proliferating at a low rate. The different smooth muscle cell phenotypes within the stent types might suggest different mechanisms of restenosis.

Long-term follow-up on a large cohort of "full-metal jacket" percutaneous coronary intervention procedures.

BACKGROUND: Limited long-term data exist on patients who have undergone drug-eluting stenting of very long lesions (requiring >or=60 mm of continuous stent) in native coronary arteries ("full-metal jacket"). METHODS AND RESULTS: We examined consecutive procedures taking place between March 2002 and 2007 at 2 high-volume centers in Milan, Italy. Exclusion criteria were percutaneous coronary intervention for restenosis, percutaneous coronary intervention to a bypass graft, or percutaneous coronary intervention for acute ST-elevation myocardial infarction (MI). We identified 658 full-metal jacket lesions in 617 patients. Average age of the cohort was 62.0+/-10.6; 32.8% were diabetic, 51.5% had a previous MI, and 33.4% had undergone a previous percutaneous transluminal coronary angioplasty. Mean ejection fraction was 52.1+/-10.4%. The lesion was a chronic total occlusion in 33.0%. Median duration of clinical follow-up was 39 months (interquartile range, 28 to 50). Six-month follow-up was achieved in 97% of patients; 2-year follow-up was achieved in 91%. All-cause mortality rate was 7.3%; cardiac death rate was 3.6%. Non-procedure-related MI rates were 3.5%. Target lesion revascularization rates were 23.4%. There were 17 cases of Academic Research Consortium-defined definite or probable stent thrombosis (2.6%): 5 acute, 2 subacute, 6 late, and 4 very late. Ten of the 17 cases occurred while the patient was receiving dual antiplatelet therapy; 4 of the 17 after premature termination of 1 or both antiplatelets, and 3 of the 17 occurred while the patient was receiving single-antiplatelet therapy, after having completed the prescribed course of dual antiplatelet therapy. CONCLUSIONS: When very long lesions (>or=60 mm) were treated using overlapping drug-eluting stents, 23.4% required a further procedure for restenosis at 3-year follow-up. However, MI, stent thrombosis, and cardiac mortality rates were relatively low.

Rotational atherectomy followed by drug-eluting stent implantation in calcified coronary lesions.

AIMS: Little information is available on the outcome after rotational atherectomy (RA) followed by drug-eluting stent (DES) implantation in calcified coronary lesions. The aim of this study was to evaluate the outcome of patients with severe lesion calcification undergoing RA followed by implantation of DES. METHODS AND RESULTS: Ninety-five patients with 96 de novo severely calcified lesions were included. Twenty-nine patients (30.5%) had diabetes mellitus and seven patients (7.4%) had chronic renal failure. The total stent length per lesion was 48.4+/-24.9 mm. Procedural success rate was 95.8%. The incidence of cumulative major adverse cardiac events, defined as death, myocardial infarction (MI) and target vessel revascularisation (TVR), was 15.8% at the mean follow-up period of 14.7 months (range 6.0-57.7). Death occurred in four patients (4.2%). Non Q-wave MI occurred in 3 patients (3.2%) and Q-wave MI occurred in two patients (2.1%). The rate of target lesion revascularisation (TLR) was 9.5%. The rate of TVR was 11.6%. Two definite (2.1%) and 2 possible (2.1%) stent thromboses were observed. CONCLUSIONS: RA followed by DES implantation in severely calcified coronary lesions appears to be feasible including high rate of procedural success and low-incidence of TLR considering this complex lesion subset.

Emergency transfemoral aortic valve-in-valve implantation with the balloon-expandable Edwards-Sapien valve.

The degeneration of a previously surgically implanted aortic bioprosthesis is an increasing etiology of aortic stenosis in the elderly, but reoperative surgery may present prohibitive risks. The feasibility of transcatheter aortic valve implantation into a conventional bioprosthesis (valve-in-valve concept) has been evaluated to decrease the reoperative risk for patients with a failed bioprosthesis. There have been several reports of valve-in-valve procedures using the self-expandable prosthesis CoreValve (Medtronic Inc.), whereas the feasibility of this procedure with the Sapien balloon expandable valve (Edwards Lifesciences Inc.) is still not well established. Here we report the case of a patient submitted to balloon-expandable aortic valve-in-valve implantation in an emergency setting to treat a severe aortic stenosis due to the premature failure of a surgical bioprosthesis.

Transapical endovascular implantation of neochordae using a suction and suture device.

OBJECTIVE: Neochordae implantation is a standard method for treatment of mitral valve prolapse. We describe a transcatheter technology enabling transapical endovascular chordal implantation. METHODS: Six adult pigs were anesthetized. Two 10F sheaths were introduced in the femoral vessels for monitoring and intracardiac echo. After midline sternotomy, the pericardium was opened, the apex was punctured inside two 2-0 polypropylene purse strings. A 0.035 in J tipped guidewire was introduced in the left ventricle and an ultra stiff 14F sheath (guide catheter) inserted through the apex. A suction-and-suture device was introduced in the left ventricle. The mitral valve was crossed under echo guidance. Using suction, either the anterior (two cases) or posterior (four cases) leaflet was captured and a loop of 4-0 polypropylene was thrown at the edge of the leaflet. The loop, with a pledget, was exteriorized through the introducer. The introducer was removed and the purse-string tied. Under echo guidance, the neochordae suture was pulled and tied over a pledget to evoke leaflet tethering. The animals were sacrificed and gross anatomy reviewed. RESULTS: Leaflet capture was feasible in the intended location in all cases. Following suture tethering, variable degrees of MR were obtained. At gross anatomy, the neochordae were positioned at 1-4mm from the leaflet free edge, and were firmly attached to the leaflets. CONCLUSIONS: Transcatheter endovascular neochordae implantation is feasible. A prolapse model is needed to further demonstrate feasibility under pathologic conditions. The apical approach allows easy and direct route to transcatheter beating heart minimally invasive mitral repair.