The future of transcatheter mitral valve interventions: competitive or complementary role of repair vs. replacement?

Transcatheter mitral interventions has been developed to address an unmet clinical need and may be an alternative therapeutic option to surgery with the intent to provide symptomatic and prognostic benefit. Beyond MitraClip therapy, alternative repair technologies are being developed to expand the transcatheter intervention armamentarium. Recently, the feasibility of transcatheter mitral valve implantation in native non-calcified valves has been reported in very high-risk patients. Acknowledging the lack of scientific evidence to date, it is difficult to predict what the ultimate future role of transcatheter mitral valve interventions will be. The purpose of the present report is to review the current state-of-the-art of mitral valve intervention, and to identify the potential future scenarios, which might benefit most from the transcatheter repair and replacement devices under development.

Neo-annulus: a reference plane in a surgical heart valve to facilitate a valve-in-valve procedure.

OBJECTIVES: To determine the level of the narrowest plane (neo-annulus) of a surgical heart valve (SHV), which could be used for sizing and securing a transcatheter heart valve (THV) during a valve-in-valve (VIV) procedure and define its relationship with the fluoroscopic markers of the SHV. BACKGROUND: In the native aortic valve, the aortic annulus is used as a reference plane for sizing and deployment of THV as it provides the narrowest dimension to securely anchor the THV. However, the reference level for different models of SHV that are currently treated by a VIV procedure remains unknown. METHODS: We studied 13 aortic SHVs from all major heart valve manufacturers (labeled size 21, 22, or 23). A 26cc valvuloplasty balloon was inflated with contrast within each SHV under fluoroscopy to achieve a 'waist'. The level of the 'waist' was compared with the SHV and its fluoroscopic markers to identify the level of the neo-annulus. RESULTS: In all SHVs tested, the balloon 'waist' or 'neo-annulus' was at the level of the sewing ring. When the fluoroscopic marker of the SHV was the sewing ring, the level of the neo-annulus was also at that level, irrespective of supra-annular or intra-annular design. However, when the fluoroscopic marker was the stent frame, the relationship between the fluoroscopic marker and the level of the neo-annulus was different for supra-annular and intra-annular designs. This correlation was not possible in two models of SHV as neither the stent nor the sewing ring was radio-opaque. CONCLUSIONS: We have demonstrated that the narrowest portion of all SHVs is at the level of its sewing ring, which can be identified fluoroscopically and should be used as a reference level during a VIV procedure.

Successful treatment of failing biological prosthesis because of "Stent creep" with valve-in-valve transcatheter aortic valve implantation.

INTRODUCTION: Stent creep is an uncommon mode of structural deterioration of bioprosthetic heart valves defined by a permanent inward deflection of the stent posts. This may occur because of valve over-sizing and leads to intrinsic valve stenosis. It has been described in older generation of bioprosthesis and was thought not to occur in modern devices. METHODS: We describe three patients who were referred for bioprosthetic valve degeneration with presumed aortic stenosis. Investigations demonstrated mid valvular gradient predominantly because of stent creep. We performed valve-in-valve TAVI with Edward SAPIEN prosthesis. RESULTS: Median age was 84 and logistic EuroSCORE 34.4. All patients had degenerated bioprosthesis with mean implant duration of 5.6 years. Two patients had Carpentier Edwards Perimount prosthesis (19 and 23 mm) and one patient had a Mitroflow (21 mm). Mean gradients were 33, 54, and 22 mm Hg. About 23 mm Edward SAPIEN valve was implanted in all cases with immediate improvement in haemodynamics with mean gradient reduction to 10, 17, and 8 mm Hg, respectively. The mean aortic valve area increased from 0.63 to 1.76cm(2) . There were no serious adverse events. The patients improved from NYHA III/IV to I/II post procedure and remain well at median follow-up of 24-months. DISCUSSION: Stent creep is an uncommon mode of structural deterioration in bioprosthetic heart valves. It has been described in the previous generation of bioprosthesis. It is important to distinguish leaflet dysfunction and stent creep. By forcing the stent posts outwards a balloon expandable TAVI device can be used to treat this condition.

Open issues in transcatheter aortic valve implantation. Part 2: procedural issues and outcomes after transcatheter aortic valve implantation.

This article provides an overview on procedure-related issues and uncertainties in outcomes after transcatheter aortic valve implantation (TAVI). The different access sites and how to select them in an individual patient are discussed. Also, the occurrence and potential predictors of aortic regurgitation (AR) after TAVI are addressed. The different methods to quantify AR are reviewed, and it appears that accurate and reproducible quantification is suboptimal. Complications such as prosthesis-patient mismatch and conduction abnormalities (and need for permanent pacemaker) are discussed, as well as cerebrovascular events, which emphasize the development of optimal anti-coagulative strategies. Finally, recent registries have shown the adoption of TAVI in the real world, but longer follow-up studies are needed to evaluate the outcome (but also prosthesis durability). Additionally, future studies are briefly discussed, which will address the use of TAVI in pure AR and lower-risk patients.

Open issues in transcatheter aortic valve implantation. Part 1: patient selection and treatment strategy for transcatheter aortic valve implantation.

An exponential increase in the use of transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis has been witnessed over the recent years. The current article reviews different areas of uncertainty related to patient selection. The use and limitations of risk scores are addressed, followed by an extensive discussion on the value of three-dimensional imaging for prosthesis sizing and the assessment of complex valve anatomy such as degenerated bicuspid valves. The uncertainty about valvular stenosis severity in patients with a mismatch between the transvalvular gradient and the aortic valve area, and how integrated use of echocardiography and computed tomographic imaging may help, is also addressed. Finally, patients referred for TAVI may have concomitant mitral regurgitation and/or coronary artery disease and the management of these patients is discussed.

Long-term mortality data from the balloon pump-assisted coronary intervention study (BCIS-1): a randomized, controlled trial of elective balloon counterpulsation during high-risk percutaneous coronary intervention.

BACKGROUND: There is conflicting evidence on the utility of elective intra-aortic balloon pump (IABP) use during high-risk percutaneous coronary intervention (PCI). Observational series have indicated a reduction in major in-hospital adverse events, although randomized trial evidence does not support this. A recent study has suggested a mortality benefit trend early after PCI, but there are currently no long-term outcome data from randomized trials in this setting. METHODS AND RESULTS: Three hundred one patients with left ventricular impairment (ejection fraction <30%) and severe coronary disease (BCIS-1 jeopardy score ≥8; maximum possible score=12) were randomized to receive PCI with elective IABP support (n=151) or without planned IABP support (n=150). Long-term all-cause mortality was assessed by tracking the databases held at the Office of National Statistics (in England and Wales) and the General Register Office (in Scotland). The groups were balanced in terms of baseline characteristics (left ventricular ejection fraction, 23.6%; BCIS-1 jeopardy score, 10.4) and the amount and type of revascularization performed. Mortality data were available for the entire cohort at a median of 51 months (interquartile range, 41-58) from randomization. All-cause mortality at follow-up was 33% in the overall cohort, with significantly fewer deaths occurring in the elective IABP group (n=42) than in the group that underwent PCI without planned IABP support (n=58) (hazard ratio, 0.66; 95% confidence interval, 0.44-0.98; P=0.039). CONCLUSIONS: In patients with severe ischemic cardiomyopathy treated with PCI, all-cause mortality was 33% at a median of 51 months. Elective IABP use during PCI was associated with a 34% relative reduction in all-cause mortality compared with unsupported PCI. CLINICAL TRIAL REGISTRATION: URL: http://www.isrctn.org. Unique identifier: ISRCTN40553718; and http://www.clinicaltrials.gov. Unique identifier: NCT00910481.

A guide to fluoroscopic identification and design of bioprosthetic valves: a reference for valve-in-valve procedure.

Surgical aortic valve replacement remains the therapy of choice in majority of patients with aortic stenosis. Bioprosthetic heart valves are often preferred over mechanical valves as they preclude the need for anticoagulation with its associated risks of bleeding and thromboembolism. However, bioprosthetic heart valves undergo structural deterioration and eventually fail. Reoperation is the standard treatment for structural failure of the bioprosthetic valve, stenosis or regurgitation but can carry a significant risk, especially in elderly patients with multiple comorbidities. Transcatheter aortic valve implantation has recently been established as a feasible alternative to conventional valve surgery for the management of high-risk elderly patients with aortic stenosis. This treatment modality has also been shown to be of benefit in the management of degenerated aortic bioprosthesis as a valve-in-valve procedure. The success of this procedure depends on a good understanding of the failing bioprostheses. This not only includes the device design but its radiological/fluoroscopic appearance and how it correlates with the implanted valve, as transcatheter aortic valve implantation is performed under fluoroscopic guidance. Here we illustrate the fluoroscopic appearance of 11 commercially available surgical bioprostheses and two commercially available transcatheter heart valves and discuss important aspects in their design which can influence outcome of a valve-in-valve procedure. We have also collated relevant information on the aspects of the design of a bioprosthetic valve, which are relevant to the valve-in-valve procedure.

Standalone balloon aortic valvuloplasty: indications and outcomes from the UK in the transcatheter valve era.

OBJECTIVES: We sought to characterize UK-wide balloon aortic valvuloplasty (BAV) experience in the TAVI era. BACKGROUND: BAV for acquired calcific aortic stenosis is in a phase of renaissance, largely due to the development of transcatheter aortic valve implantation (TAVI). METHODS: Data from 423 patients at 14 centers across the UK were analyzed. RESULTS: Patients were aged 80.9 ± 9.5 years; 52.5% were male. Mean logistic EuroScore was 27.3% ± 16.8%. Mean peak transaortic gradient fell from 62.0 ± 26.3 to 28.3 ± 16.2 mm Hg. Aortic valve area increased from 0.58 ± 0.19 to 0.80 ± 0.25 cm(2) echocardiographically. Procedural complication rate was 6.3%, comprising death (2.4%), blood transfusion ≥ 2 U (1.2%), cardiac tamponade (1.0%), stroke (1.0%), vascular surgical repair (1.0%), coronary embolism (0.5%), and permanent pacemaker (0.2%). Mortality was 13.8% at 30 days and 36.3% at 12 months. Subsequently, 18.3% of patients underwent TAVI and 7.0% sAVR, with improved survival compared to those who had no further intervention (logrank < 0.0001). Multivariate Cox proportional hazard analysis demonstrated that survival was adversely effected by the presence of coronary artery disease (HR 1.53, 95%CI 1.08-2.17, P = 0.018), poor LV function (HR 1.54, 95%CI 1.09-2.16, P = 0.014), and either urgent (HR 1.70, 95%CI 1.18-2.45; P = 0.004) or emergent presentation (HR 3.72, 95%CI 2.27-6.08; P < 0.0001). CONCLUSION: Balloon aortic valvuloplasty offers good immediate hemodynamic efficacy at an acceptable risk of major complications. Medium-term prognosis is poor in the absence of definitive therapy.

Transaortic transcatheter aortic valve implantation for failed surgical aortic valve replacement due to 'porcelain aorta'.

Transcatheter aortic valve implantation (TAVI) is an emerging surgical approach in patients with severe aortic stenosis unsuitable for conventional aortic valve replacement (AVR). TAVI has been performed through both transfemoral and transapical approaches, each with a specific suitability criterion. A transaortic (TAo-TAVI) approach has been recently established at the authors' institution for high-risk patients who are unsuited to the above techniques. Herein, the case is described of a successful aortic valve implantation using TAo-TAVI in a patient with porcelain ascending aorta that was identified as an incidental finding during conventional AVR. The patient recovered well and was discharged home without any complications.

One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve.

BACKGROUND: Transcatheter aortic valve implantation was developed to provide a therapeutic option for patients considered to be ineligible for, and to mitigate mortality and morbidity associated with, high-risk surgical aortic valve replacement. METHODS AND RESULTS: The Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry was designed to assess initial post commercial clinical transcatheter aortic valve implantation results of the Edwards SAPIEN valve in consecutive patients in Europe. Cohort 1 consists of 1038 patients enrolled at 32 centers. One-year outcomes are presented. Patients with the transapical approach (n=575) suffered more comorbidities than transfemoral patients (n=463) with a significantly higher logistic EuroSCORE (29% versus 25.8%; P=0.007). These groups are different; therefore, outcomes cannot be directly compared. Total Kaplan Meier 1-year survival was 76.1% overall, 72.1% for transapical and 81.1% for transfemoral patients, and 73.5% of surviving patients were in New York Heart Association (NYHA) class I or II at 1 year. Combined transapical and transfemoral causes of death were cardiac in 25.1%, noncardiac in 49.2%, and unknown in 25.7%. Pulmonary complications (23.9%), renal failure (12.5%), cancer (11.4%), and stroke (10.2%) were the most frequent noncardiac causes of death. Multivariable analysis identified logistic EuroSCORE, renal disease, liver disease, and smoking as variables with the highest hazard ratios for 1-year mortality whereas carotid artery stenosis, hyperlipidemia, and hypertension were associated with lower mortality. CONCLUSION: The SOURCE Registry is the largest consecutively enrolled registry for transcatheter aortic valve implantation procedures. It demonstrates that with new transcatheter aortic techniques excellent 1-year survival in high-risk and inoperable patients is achievable and provides a benchmark against which future transcatheter aortic valve implantation cohorts and devices can be measured.

How opening two chronic total occlusions may be easier than just one.

Recanalization of chronic total occlusions (CTOs) via grafts has been described previously. However, the insertion of the graft into the distal vessel is often characterized by an unfavorable entry angle which renders an antegrade approach challenging. In the present case, we describe how retrograde recanalization of the proximal right coronary artery (RCA) via a right internal mammary artery graft facilitated antegrade revascularization of the CTO of the RCA.

Transaortic Transcatheter Aortic valve implantation using Edwards Sapien valve: a novel approach.

OBJECTIVES: To evaluate feasibility and outcome of Transoartic Transcatheter Sapien valve implantation. BACKGROUND: Transcatheter Aortic valve implantation (TAVI) using the Edwards SAPIEN device (Edwards LifeScience, Irvine, CA) is usually performed via the transfemoral (TF) or transapical (TA) routes. Some patients are not suitable for these approaches. We report our experience with the novel transaortic (TAo) approach via a partial upper sternotomy and discuss the advantages and future applications. METHODS: Between January 2008 to March 2011 193 patients with severe aortic stenosis underwent TAVI with the Edwards SAPIEN bioprosthesis at the St. Thomas' Hospital, London. 108 patients were unable to undergo a TF-TAVI and of those 17 were accepted for a TAo-TAVI on the basis of anatomy, risk, LV function, and significant respiratory disease. RESULTS: The TAo-TAVI group (n = 17) had more prevalent respiratory disease than the TA-TAVI group (47.0% vs. 18.7%, P = 0.011). Otherwise the groups were similar in demographics and history. Despite this the 30 day mortalities were not significantly different between the groups (TAo-TAVI 4.3% at 30 days versus TA-TAVI 7.7%, P = 0.670). There were no significant differences in procedural complications. CONCLUSIONS: The TA-TAVI approach may not be desirable in patients with severe chest deformity, poor lung function or poor left ventricular function. TAo-TAVI via a partial sternotomy is safe and feasible in these patients.

One year follow-up of the multi-centre European PARTNER transcatheter heart valve study.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has emerged as a new therapeutic option in high-risk patients with severe aortic stenosis. AIMS: PARTNER EU is the first study to evaluate prospectively the procedural and mid-term outcomes of transfemoral (TF) or transapical (TA) implantation of the Edwards SAPIEN® valve involving a multi-disciplinary approach. METHODS AND RESULTS: Primary safety endpoints were 30 days and 6 months mortality. Primary efficacy endpoints were haemodynamic and functional improvement at 12 months. One hundred and thirty patients (61 TF, 69 TA), aged 82.1 ± 5.5 years were included. TA patients had higher logistic EuroSCORE (33.8 vs. 25.7%, P = 0.0005) and more peripheral disease (49.3 vs. 16.4%, P< 0.0001). Procedures were aborted in four TA (5.8%) and six TF cases (9.8%). Valve implantation was successful in the remaining patients in 95.4 and 96.4%, respectively. Thirty days and 6 months survival were 81.2 and 58.0% (TA) and 91.8 and 90.2% (TF). In both groups, mean aortic gradient decreased from 46.9 ± 18.1 to 10.9 ± 5.4 mmHg 6 months post-TAVI. In total, 78.1 and 84.8% of patients experienced significant improvement in New York Heart Association (NYHA) class, whereas 73.9 and 72.7% had improved Kansas City Cardiomyopathy Questionnaire (KCCQ) scores in TA and TF cohorts, respectively. CONCLUSION: This first team-based multi-centre European TAVI registry shows promising results in high-risk patients treated by TF or TA delivery. Survival rates differ significantly between TF and TA groups and probably reflect the higher risk profile of the TA cohort. Optimal patient screening, approach selection, and device refinement may improve outcomes.

Transapical transcatheter aortic valve implantation in a complex aortic surgical patient: A case involving the youngest valve-in-valve implantation with a 29 mm transcather valve.

The present article reports a case involving a 29-year-old man who developed severe cardiac failure (New York Heart Association class IV). He had a complex surgical history, beginning with the repair of an anterior sinus of Valsalva aneurysm and closure of a ventricular septal defect at eight months of age. His residual Valsalva aneurysm and mixed aortic valve disease necessitated mechanical aortic valve replacement at 14 years of age. One year later, he developed coagulase-negative staphylococcal prosthetic valve infective endocarditis, necessitating an additional replacement of his valve with a pulmonary homograft. Subsequent follow-up revealed a dilated ascending aorta (6 cm) and increased regurgitation through his homograft, with significant dilation of the left ventricle. At 20 years of age, he underwent excision of the aneurysmal ascending aorta and arch of the aorta, and the aortic valve was replaced with a 29 mm bioprosthetic valve. This proved satisfactory for nine years until he presented at Guy's and St Thomas' National Health Services Foundation Trust (London, United Kingdom) with severe aortic regurgitation. His logistic EuroScore was 5.9 and Parsonnet score was 17 but, due to extensive previous surgery, he was considered and accepted for transcatheter aortic valve implantation. A 29 mm Edwards Sapien valve (Edwards Lifesciences, USA) was successfully implanted using a valve-in-valve procedure. The patient remained well and symptom free at early follow-up. Technical aspects of this complex adult congenital case that, to the authors' knowledge is the youngest case of transcatheter aortic valve implantation and the first 29 mm valve-in-valve procedure, are discussed.

Bioprosthetic Aortic Valve Hemodynamics: Definitions, Outcomes, and Evidence Gaps: JACC State-of-the-Art Review.

A virtual workshop was organized by the Heart Valve Collaboratory to identify areas of expert consensus, areas of disagreement, and evidence gaps related to bioprosthetic aortic valve hemodynamics. Impaired functional performance of bioprosthetic aortic valve replacement is associated with adverse patient outcomes; however, this assessment is complicated by the lack of standardization for labelling, definitions, and measurement techniques, both after surgical and transcatheter valve replacement. Echocardiography remains the standard assessment methodology because of its ease of performance, widespread availability, ability to do serial measurements over time, and correlation with outcomes. Management of a high gradient after replacement requires integration of the patient's clinical status, physical examination, and multimodality imaging in addition to shared patient decisions regarding treatment options. Future priorities that are underway include efforts to standardize prosthesis sizing and labelling for both surgical and transcatheter valves as well as trials to characterize the consequences of adverse hemodynamics.

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.

Randomized trial of simple versus complex drug-eluting stenting for bifurcation lesions: the British Bifurcation Coronary Study: old, new, and evolving strategies.

BACKGROUND: The optimal strategy for treating coronary bifurcation lesions remains a subject of debate. With bare-metal stents, single-stent approaches appear to be superior to systematic 2-stent strategies. Drug-eluting stents, however, have low rates of restenosis and might offer improved outcomes with complex stenting techniques. METHODS AND RESULTS: Patients with significant coronary bifurcation lesions were randomized to either a simple or complex stenting strategy with drug-eluting stents. In the simple strategy, the main vessel was stented, followed by optional kissing balloon dilatation/T-stent. In the complex strategy, both vessels were systematically stented (culotte or crush techniques) with mandatory kissing balloon dilatation. Five hundred patients 64+/-10 years old were randomized; 77% were male. Eighty-two percent of lesions were true bifurcations (>50% narrowing in both vessels). In the simple group (n=250), 66 patients (26%) had kissing balloons in addition to main-vessel stenting, and 7 (3%) had T stenting. In the complex group (n=250), 89% of culotte (n=75) and 72% of crush (n=169) cases were completed successfully with final kissing balloon inflations. The primary end point (a composite at 9 months of death, myocardial infarction, and target-vessel failure) occurred in 8.0% of the simple group versus 15.2% of the complex group (hazard ratio 2.02, 95% confidence interval 1.17 to 3.47, P=0.009). Myocardial infarction occurred in 3.6% versus 11.2%, respectively (P=0.001), and in-hospital major adverse cardiovascular events occurred in 2.0% versus 8.0% (P=0.002), respectively. Procedure duration and x-ray dose favored the simple approach. CONCLUSIONS: When coronary bifurcation lesions are treated, a systematic 2-stent technique results in higher rates of in-hospital and 9-month major adverse cardiovascular events. This difference is largely driven by periprocedural myocardial infarction. Procedure duration is longer, and x-ray dose is higher. The provisional technique should remain the preferred strategy in the majority of cases. Clinical Trial Registration Information- URL: http://www.clinicaltrials.gov. Unique identifier: NCT 00351260.

Usage patterns and 1-year outcomes with the TAXUS Liberté stent: results of the TAXUS OLYMPIA registry.

OBJECTIVES: The TAXUS OLYMPIA registry is a prospective, global, post-approval program designed to collect clinical outcome data through 1 year from patients receiving the TAXUS Liberté paclitaxel-eluting stent in routine interventional cardiology practice. BACKGROUND: The thin-strut TAXUS Liberté stent has been studied in ongoing clinical trials with specific inclusion/exclusion criteria. METHODS: Between September 2005 and April 2007, a total of 21,954 patients from 365 sites in 57 countries eligible to receive a TAXUS Liberté stent were enrolled in the TAXUS OLYMPIA registry. Baseline characteristics and procedure patterns were collected and clinical follow-up is available for 1 year. The primary endpoint was the composite cardiac event (cardiac death, MI, and reintervention of the target vessel) rate related to the TAXUS Liberté stent at 1 year. All cardiac events were monitored and all endpoints were independently adjudicated. RESULTS: Complex patients and lesions were prevalent, including: 27% medically-treated diabetes, 58% ACC/AHA type B2/C lesions, 32% multiple stenting, 13% long lesions (>28 mm), and 10% small vessels (<2.5 mm). At 1 year, the composite cardiac event rate was 4.4%, including 1.4% cardiac death, 1.0% MI, and 3.2% TVR. Stent thrombosis (ST, angiographically confirmed) occurred in 0.8% of patients, with 0.4% ST occurring >30 days postprocedure. The composite cardiac event rate related to the TAXUS Liberté stent was 3.8% at 1 year. CONCLUSIONS: Low 1-year cardiac event rates were reported with TAXUS Liberté in a broad spectrum of patients, thereby confirming the technical and clinical performance of this stent in a "real-world" setting.

Quadripolar left ventricular lead implantation through the anchor struts of a mitral valve annuloplasty device.

We describe cardiac resynchronization therapy in a patient with a mitral valve annuloplasty device in situ for functional mitral regurgitation. We successfully implanted a left ventricular lead through a mitral valve annuloplasty device anchor into the coronary sinus and then through the struts of the device's proximal anchor.

ACTIVATION (PercutAneous Coronary inTervention prIor to transcatheter aortic VAlve implantaTION): A Randomized Clinical Trial.

OBJECTIVES: This study sought to determine if percutaneous coronary intervention (PCI) prior to transcatheter aortic valve replacement (TAVR) in patients with significant coronary artery disease would produce noninferior clinical results when compared with no PCI (control arm). BACKGROUND: PCI in patients undergoing TAVR is not without risk, and there are no randomized data to inform clinical practice. METHODS: Patients with severe symptomatic aortic stenosis and significant coronary artery disease with Canadian Cardiovascular Society class ≤2 angina were randomly assigned to receive PCI or no PCI prior to TAVR. The primary endpoint was a composite of all-cause death or rehospitalization at 1 year. Noninferiority testing (prespecified margin of 7.5%) was performed in the intention-to-treat population. RESULTS: At 17 centers, 235 patients underwent randomization. At 1 year, the primary composite endpoint occurred in 48 (41.5%) of the PCI arm and 47 (44.0%) of the no-PCI arm. The requirement for noninferiority was not met (difference: -2.5%; 1-sided upper 95% confidence limit: 8.5%; 1-sided noninferiority test P = 0.067). On analysis of the as-treated population, the difference was -3.7% (1-sided upper 95% confidence limit: 7.5%; P = 0.050). Mortality was 16 (13.4%) in the PCI arm and 14 (12.1%) in the no-PCI arm. At 1 year, there was no evidence of a difference in the rates of stroke, myocardial infarction, or acute kidney injury, with higher rates of any bleed in the PCI arm (P = 0.021). CONCLUSIONS: Observed rates of death and rehospitalization at 1 year were similar between PCI and no PCI prior to TAVR; however, the noninferiority margin was not met, and PCI resulted in a higher incidence of bleeding. (Assessing the Effects of Stenting in Significant Coronary Artery Disease Prior to Transcatheter Aortic Valve Implantation; ISRCTN75836930).