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With U.S. Food and Drug Administration approval of the MitraClip, percutaneous mitral valve procedures have increased in frequency and are performed at a wide range of hospitals with varying levels of experience. These procedures are often challenging, with technical and imaging nuances that are

We would like to thank Dr. Felix-Oliveira and colleagues for bringing up a very important alternative for contralateral access. The idea of using the radial artery as an alternative access site for crossover is appealing, and the initial data from a small number of patients (N = 46) showed no

There is a paucity of data regarding the optimum timing of percutaneous coronary intervention (PCI) in relation to transcatheter aortic valve replacement (TAVR). We compared the major adverse cardiovascular and cerebrovascular events (MACCE) rates among patients who underwent PCI before TAVR with

An 88-year-old woman with severe symptomatic functional mitral regurgitation in spite of optimal medical therapy was referred for percutaneous mitral annuloplasty with the Cardioband system (Edwards Lifesciences, Irvine, California). Transesophageal echocardiogram revealed an ejection fraction of

Objectives The aim of this report is to characterize the impact of balloon aortic valvuloplasty (BAV) in patients not undergoing aortic valve replacement in the PARTNER (Placement of AoRtic TraNscathetER Valves) trial. Background The PARTNER trial is the only randomized trial with independently adjudicated data of inoperable severe symptomatic aortic stenosis patients, allowing outcome analysis of unoperated-on patients. Methods The design and initial results of the PARTNER trial (Cohort B) were reported previously. After excluding patients with pre-randomization BAV, we compared patients undergoing BAV within 30 days of randomization (BAV group) with those not having BAV within 30 days of randomization (no BAV group) to characterize the use and impact of BAV. Results In the PARTNER Cohort B study, 179 inoperable patients were randomized to standard treatment including 39 patients (21.8%) who had undergone a BAV before randomization (previous BAV group). Of the 140 patients who did not have BAV before enrollment in the study, 102 patients (73%) had BAV within 30 days of study randomization (BAV group). Survival at 3 months was greater in the BAV group compared with the no BAV group (88.2%; 95% confidence interval [CI]: 82.0% to 94.5% vs. 73.0%; 95% CI: 58.8% to 87.4%). However, survival was similar at 6-month follow-up (74.5%; 95% CI: 66.1% to 83.0% vs. 73.1%; 58.8% to 87.4%). There was improvement in quality of life parameters when paired comparisons were made between baseline and 30 days and 6 months between the BAV and no BAV groups, but this effect was lost at 12-month follow-up. Conclusions BAV improves functional status and survival in the short term, but these benefits are not sustained. BAV for aortic stenosis patients who cannot undergo aortic valve replacement is a useful palliative therapy. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894 )

Objectives The purpose of this study was to identify predictors and clinical implications of permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR). Background Cardiac conduction disturbances requiring PPM are a frequent complication of TAVR. However, limited data is available regarding this complication after TAVR with a balloon-expandable valve. Methods The study included patients without prior pacemaker who underwent TAVR in the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry and investigated predictors and clinical effect of new PPM. Results Of 2,559 TAVR patients, 586 were excluded due to pre-existing PPM. A new PPM was required in 173 of the remaining 1,973 patients (8.8%). By multivariable analysis, predictors of PPM included right bundle branch block (odds ratio [OR]: 7.03, 95% confidence interval [CI]: 4.92 to 10.06, p Conclusions PPM was required in 8.8% of patients without prior PPM who underwent TAVR with a balloon-expandable valve in the PARTNER trial and registry. In addition to pre-existing right bundle branch block, the prosthesis to LV outflow tract diameter ratio and the LV end-diastolic diameter were identified as novel predictors of PPM after TAVR. New PPM was associated with a longer duration of hospitalization and higher rates of repeat hospitalization and mortality or repeat hospitalization at 1 year. (THE PARTNER TRIAL: Placement of AoRtic TraNscathetER Valves Trial; NCT00530894 )

Objectives This study sought to determine whether outcomes for transfemoral (TF) transcatheter aortic valve replacement (TAVR) differ between the randomized controlled trial (RCT) and the subsequent NRCA (Nonrandomized Continued Access) registry of the PARTNER (Placement of AoRTic TraNscathetER Valves) trial. Background The PARTNER RCT demonstrated that TAVR with the Edwards Sapien valve (Edwards Lifesciences, Irvine, California) is noninferior to surgery in high-risk patients and superior to standard therapy for inoperable patients. Methods The inclusion and exclusion criteria, data collection, monitoring, and core laboratories were the same for the RCT and NRCA registry. Baseline characteristics, procedural results, and 1-year outcomes were compared between patients undergoing TF-TAVR as part of the RCT and as part of the NRCA registry. Results In the RCT, 415 patients underwent TF-TAVR, whereas in the NRCA, 1,023 patients did. At 30 days, death, cardiac death, stroke, and transient ischemic attacks were not different in the NRCA registry than in the RCT. Major vascular complications (8.0% vs. 15.7%, p Conclusions The large NRCA registry demonstrates further improvement in procedural and longer-term outcomes after TF-TAVR when compared with the favorable results from the PARTNER RCT. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894 ).

Objectives This study investigated whether patients with patent foramen ovale (PFO) have an increased risk of stroke due to permanent pacemaker (PPM)/implantable cardioverter-defibrillator (ICD) implantation. Background Data are lacking on the risk of stroke in patients with PFO and implantable intracardiac devices, either a PPM or an ICD. We investigated whether patients with PFO have increased risk of stroke due to PPM/ICD implantation. Methods Between 2001 and 2008, 2,921 consecutive patients with PFO (67.5 ± 16.4 years of age, 52.2% male) were identified from our echocardiography database. These patients were divided into a device group (patients had PPM/ICD implantation for any reason after receiving a diagnosis of PFO) and a no device group (patients did not have PPM or ICD implantation). Patients who had PFO closure during follow-up were excluded. Both groups were matched for baseline characteristics and medications. The incidence of ischemic stroke was assessed in each group after propensity score matching (case:control ratio of 1:1 yielding 231 pairs). All patients completed at least 4 years of follow-up until May 2012. Results There were 2,690 patients in the n device group (67.3 ± 16.4 years of age, 51.6% male) and 231 patients in the device group (75.4 ± 14.6 years of age, 59.3% male). Six patients (2.6%) in the no device group and 6 (2.6%) in the device group had a stroke during the follow-up period. No difference in the rate of stroke, transient ischemic stroke, or stroke/transient ischemic stroke was observed between the 2 groups. Conclusions The risk of stroke in patients with PFO and an implantable intracardiac device is similar to those without an intracardiac device. In patients with PFO, without a history of stroke, device implantation might not be considered a risk factor for future stroke occurrence.

Objectives This study sought to characterize the patients receiving post-implantation balloon dilation (PD) following transcatheter aortic valve replacement (TAVR) and evaluate procedural outcomes in the PARTNER (Placement of Aortic Transcatheter Valve) I trial. Background Following TAVR, PD has been used to treat paravalvular regurgitation. Methods The PARTNER I trial cohort A (n = 304) and cohort B (n = 194) patients randomized to TAVR and the nonrandomized continued access TAVR (n = 1,637) patients were included in the analysis. PD was performed at the discretion of the operator. Clinical events and echocardiographic variables were collected prospectively out to 1 year. Results The overall incidence of PD was 12.4%. PD patients had significantly less prosthesis-patient mismatch (p 30 days (1.9 vs. 1.7%; p = 0.75). Although there was no significant increase in early mortality with PD, at 1 year, there was a trend for higher all-cause mortality (p = 0.054) and a significant difference in death or stroke (p = 0.04). When the subgroup of patients with none/trace paravalvular regurgitation were evaluated, there was no significant association of PD with mortality (p = 0.61) and death or stroke (p = 0.96). Multivariable analysis failed to show a relationship between PD and mortality. Conclusions PD is associated with reduced rates of moderate or severe prosthesis-patient mismatch with no evidence for short-term structural deterioration of the balloon-expandable transcatheter valve. Although PD is associated with a greater incidence of early stroke, there is no significant association between PD and stroke beyond 7 days. Multivariable analysis shows no significant association between PD and mortality.

ObjectivesThe aim of this study was to analyze the relationship between beam angulation and air kerma in a modern cardiac catheterization laboratory.BackgroundRecent reports have identified the merits of reducing radiation scatter, an important determinant of radiation dose in the catheterization laboratory. Radiation scatter is poorly characterized in the context of catheterization laboratories using modern digital equipment. Understanding the principles of dosimetry may reduce the radiation exposure to patients, providers, and medical staff.MethodsProspectively captured radiation data were extracted from a database of 1,975 diagnostic catheterizations (DCs) and 755 percutaneous coronary interventions (PCIs), which included 138,342 fluoroscopic and 35,440 acquisition (cine) sequences. Fluoroscopy and acquisition modes were categorized into tertiles based on the total air kerma measured at a standard reference point. Radiation maps were modeled according to the relative proportion of exposure in each projection.ResultsMedian air kerma during DCs and PCIs was 677 and 2,188 mGy, respectively. Fluoroscopy contributed to 66.3% of total dose during PCIs compared with 39.7% during DCs (p

Transcatheter aortic valve replacement (TAVR) is an established treatment for severe symptomatic aortic stenosis patients who are not suitable or are at high risk for surgical aortic valve replacement (SAVR) [(1–3)][1]. Several ongoing studies are exploring its role in lower risk patients [(4)][2

Objectives The goal of this study was to provide a systematic review and analysis of observational studies on percutaneous left atrial appendage (LAA) occlusion for stroke prophylaxis in nonvalvular atrial fibrillation (NVAF). Background A recent randomized controlled trial in patients with NVAF suggested noninferiority of percutaneous LAA occlusion versus medical management for stroke prevention. However, the use of percutaneous devices remains controversial because of limited literature on their efficacy and safety. We performed a systematic analytical review of existing observational studies to assess the rate of neurological events for patients treated with occlusion devices. Methods A comprehensive search of the Medline, Scopus, and Web of Science databases from inception through August 1, 2013, was conducted using pre-defined criteria. We included studies reporting implantation in at least 10 patients and a follow-up of 6 months or more. Results In 17 eligible studies, a total of 1,052 devices were implanted in 1,107 patients with 1,586.4 person-years (PY) of follow-up. The adjusted incidence rate of stroke was 0.7/100 PY (95% confidence interval [CI]: 0.3 to 1.1/100 PY), of transient ischemic attacks was 0.5/100 PY (95% CI: 0.1 to 1.8/100 PY), and of combined neurological events (strokes or transient ischemic attacks) was 1.1/100 PY (95% CI: 0.6 to 1.6/100 PY). Access site vascular complications and pericardial effusion were the most commonly observed procedural complications at a rate of 8.6% (95% CI: 6.3% to 11.7%) and 4.3% (95% CI: 3.1% to 5.9%), respectively. Conclusions Our systematic review suggested comparable efficacy of LAA occlusion devices compared with historical controls treated with adjusted-dose warfarin and other anticoagulation strategies for prevention of stroke in patients with NVAF.

Objectives: The goal of this study was to provide a systematic review comparing the long-term outcomes of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) versus coronary art...

A 66-year-old woman who previously underwent coronary artery bypass surgery was admitted due to anginal symptoms. Coronary angiography (CAG) revealed a severe stenosis of the right coronary artery at the anastomotic site of a saphenous vein graft (SVG) and a residual stenosis of the posterior