A new intravascular ultrasound-guided stenting strategy compared with angiography on stent expansion and procedural outcomes in patients with positive lesion remodeling.

OBJECTIVES: We investigated the role of a new intravascular ultrasound (IVUS)-guided stenting strategy versus angiography on optimal stent expansion (OSE) and procedural outcomes in patients with positive lesion remodeling. BACKGROUND: There are no IVUS criteria on how to achieve OSE. METHODS: A total of 100 patients were assigned to a new IVUS-guided stenting strategy (IVUS group) versus angiography-guided stenting (Angio group). In the IVUS group, among patients with positive lesion remodeling, defined as a remodeling ratio (RR; lesion external elastic membrane (EEM) area/distal reference EEM area) >1.05, the stent was expanded with a balloon sized to the distal reference EEM diameter. In the Angio group, the stent was expanded by visual estimation. In both groups, IVUS was performed after postdilation. RESULTS: Minimum stent area (MSA) and stent volume index were significantly larger in the IVUS versus Angio group (7.1 ± 1.9 vs. 5.9 ± 1.5 mm2 , and 8.7 ± 2.1 vs. 7.5 ± 1.8 mm3 /mm, respectively; p < .01). The percentages of OSE, defined as an MSA ≥5.4 mm2 , MSA ≥90% of distal reference lumen area (DRLA), or MSA > DRLA, were significantly higher in the IVUS versus Angio group (80 vs. 56%, 78 vs. 54%, and 71 vs. 38%, respectively; p < .01). Stent underexpansion, malapposition, and residual reference segment stenosis were significantly higher in the Angio versus IVUS group (44 vs. 12%, 16 vs. 4%, and 12 vs. 0%, respectively; p < .05). In the IVUS group, owing to positive remodeling, there was no incidence of dissection or perforation. CONCLUSIONS: This new strategy of IVUS-guided stenting in patients with positive lesion remodeling, compared with angiography, significantly increased stent expansion and decreased stent underexpansion, malapposition, and residual reference segment stenosis with no complications.

Simultaneous transcatheter pulmonary and tricuspid valve-in-valve implantation for the treatment of failing pulmonary and tricuspid bioprostheses.

We report a case of a patient with a history of bioprosthetic pulmonary and tricuspid valve replacement who developed significant stenosis and regurgitation of the bioprosthetic valves. Due to multiple comorbidities, he was deemed high risk for redo-valve replacement surgery. He subsequently underwent percutaneous transcatheter pulmonary and tricuspid valve-in-valve procedure at the same setting. This is the first of such that is reported in the literature. © 2015 Wiley Periodicals, Inc.

Emergent transcatheter mitral valve-in-valve implantation in a patient with cardiogenic shock secondary to a failed mitral bioprosthesis.

Transcatheter valve-in-valve (VIV) implantation is emerging as a therapeutic option for treatment of failed bioprosthesis in patients that are deemed high-risk or inoperable for redo-valve replacement. It can be carried out in suitable bioprosthetic valves in any position and usually performed as an elective or semi-elective procedure. Here, we report a case of emergent transcatheter VIV implantation in a failed mitral bioprosthesis in a critically ill patient with cardiogenic shock. We conclude that transcatheter VIV implantation may also be an option for critically ill patients with failing bioprosthesis. © 2015 Wiley Periodicals, Inc.

Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance.

OBJECTIVES: To assess technical performance learning curves of teams performing transfemoral transcatheter aortic valve replacement (TF-TAVR). BACKGROUND: TF-TAVR is a new procedure for treating severe aortic stenosis. The number of cases required for procedural efficiency is unknown. METHODS: In the PARTNER-I trial, 1,521 patients underwent TF-TAVR from 4/2007-2/2012. Learning curve analysis of technical performance metrics was performed using institution-specific patient sequence number, interval between procedures, and institutional trial entry date. Learning curve characteristics were assessed using semi-parametric and parametric mixed-effects models. RESULTS: As patient sequence number increased, average procedure time decreased from 154 to 85 minutes (P < 0.0001), and fluoroscopy time from 28 to 20 minutes (P < 0.0001). Procedure time plateaued at an average of 83 minutes (range 52-140). Procedure time plateau was dynamic during the course of the trial, averaging 25 cases (range 21-52) by its end. The later institutions enrolled in the trial, the shorter the initial procedure time. During the trial, percutaneous rather than surgical access increased from 7.9% to 69%. CONCLUSIONS: Technical performance learning curves exist for TF-TAVR; procedural efficiency increased with experience, with concomitant decreases in radiation and contrast media exposure. The number of cases needed to achieve efficiency decreased progressively, with optimal procedural performance reached after approximately 25 cases for late-entering institutions. Knowledge and experience accumulated by early TF-TAVR institutions were disseminated, shortening the learning curve of late-entering institutions. Technological advances resulting from learning during the trial moved the field from initial conservative surgical cut-down to percutaneous access for most patients. © 2015 Wiley Periodicals, Inc.

Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Success and safety.

OBJECTIVES: To identify number of cases needed to maximize device success and minimize adverse events after transfemoral transcatheter aortic valve replacement (TF-TAVR), and determine if adverse events were linked to the technical performance learning curve. BACKGROUND: TF-TAVR is a complex procedure with an incompletely characterized learning curve for clinical outcomes. METHODS: From 4/2007-2/2012, 1521 patients underwent TF-TAVR in the PARTNER-I trial. Outcomes learning curves were defined as number of cases needed to reach a plateau for device success, adverse events, and post-procedure length of stay. Institutional variation was accounted for by mixed-model non-linear techniques, which were also used to identify contribution of the procedure time learning curve to 30-day major adverse events and length of stay. RESULTS: Eighty percent device success was achieved after 22 cases; major vascular complications fell below 5% after 70 cases and major bleeding below 10% after 25 cases. It took an average of 28 cases to achieve a consistent low risk of 30-day major adverse events, but institutions entering in the middle of the trial achieved it after about 26. The most significant correlate of 30-day major adverse events and post-procedure length of stay was procedure time (P < 0.0001). However, this association was related to patient and unmeasured variables, not the procedure time learning curve (P = 0.6). CONCLUSIONS: By end of trial, a consistent low risk of adverse events was achieved after ∼26 cases. However, these improved results were due to change in patient risk profile; outcomes were not linked to the technical performance learning curve. © 2015 Wiley Periodicals, Inc.

Percutaneous valvuloplasty for severe bioprosthetic tricuspid valve stenosis in the setting of infective endocarditis.

Bioprosthetic tricuspid valve stenosis as a sequela of infective endocarditis is extremely rare. We describe the case of a 29-year-old male patient with a history of intravenous drug use and two previous bioprosthetic tricuspid valve placements who presented with recurrent endocarditis and severe tricuspid stenosis. He was deemed extremely high risk for redo valve replacement surgery. Intracardiac ultrasound-guided balloon valvuloplasty was performed with good clinical outcome. We believe that interventional treatment of prosthetic valvular stenosis in the setting of endocarditis is a reasonable therapeutic choice when open surgical repair is associated with prohibitively high mortality. This can be performed either as destination therapy or as a bridge to valve replacement. The use of intracardiac ultrasound provided additive information to that obtained by transthoracic and transesophageal echocardiography.

Usefulness of three-dimensional transesophageal echocardiography in retrieval of a dislodged vascular plug used to close paraprosthetic mitral regurgitation.

In this report, we describe a case of periprocedural dislodgement of an Amplatzer Vascular Plug II device during percutaneous closure of severe paraprosthetic mitral regurgitation. The free plug in the left atrium was successfully retrieved percutaneously using a snare inserted through a sheath under live/real time three-dimensional transesophageal echocardiographic guidance. This proved crucial not only in guiding device deployment but also in detecting and helping management of complications.

Tricuspid Annular Plane Systolic Excursion and Its Association with Mortality in Critically Ill Patients.

BACKGROUND: Transient left ventricular dysfunction can occur under conditions of extreme emotional or physiological stress. There is little data on right ventricular function in such situations. METHODS: One hundred twenty patients admitted to an ICU with a noncardiac illness were studied. Those with documented coronary disease, ejection fraction <40%, sepsis, or intracranial hemorrhage were excluded. Echocardiograms were performed within 24 hours of admission. Tricuspid annular plane systolic excursion (TAPSE) was measured to assess right ventricular systolic function. Plasma catecholamines (norepinephrine, epinephrine, dopamine) were measured on admission. Clinical and demographic data were collected, along with data on ICU length of stay (LOS), hospital LOS, and in-hospital and long-term mortality. TAPSE was tested for correlation with adverse outcomes and length of stay. RESULTS: Mean TAPSE for the group was 2.05 ± 0.66 cm. Based on area under the ROC curve analysis, TAPSE <2.4 cm was the best cutoff for predicting in-hospital and long-term mortality. There were 13 in-hospital deaths, 12 in the group with TAPSE <2.4 cm and one among those with TAPSE ≥2.4 cm. On multivariate analysis, TAPSE <2.4 cm was a significant predictor of in-hospital mortality (χ(2)  = 4.6, P = 0.03). When tested against hospital LOS, an inverse correlation was found (P = 0.04). No association was found between TAPSE and catecholamine levels. CONCLUSIONS: Right ventricular systolic function, as assessed by TAPSE, has important prognostic value in critically ill patients. Mean values were lower in patients who died in-hospital versus those who survived to discharge. In addition, patients with TAPSE <2.4 cm had a longer hospital length of stay.

Republished: Left atrial appendage occlusion.

Left atrial appendage (LAA) occlusion for stroke and thromboembolism prevention in patients with atrial fibrillation (AF) represents a significant advancement in the field of cardiovascular disease. Prevention and avoidance of the devastating consequences of thromboembolic complications from AF continues to be central in the management of these patients. The role of LAA as a nidus for thrombus formation is well documented. Multiple approaches to exclude the LAA from the circulation either percutaneously or surgically have been described and are undergoing testing. Although pharmacological therapy for stroke prevention remains the cornerstone of treatment, device and surgical exclusion of the LAA have proven to be viable alternatives in carefully selected patients. Even though current evidence show that LAA occlusion is safe and effective, approval and adoption of this strategy has been quite difficult due to paucity of randomised clinical trial data on the risk and benefit ratio, cost effectiveness and the issues of procedural risk as well as longer-term outcome. This review aims to provide an update on the current status of LAA occlusion, specifically looking at interpretation of current clinical data, available techniques and devices, issues with current devices and future direction.

Incremental value of three-dimensional transesophageal echocardiography over the two-dimensional technique in percutaneous closure of aortic paraprosthetic regurgitation.

We describe 2 patients with significant aortic paraprosthetic regurgitation who underwent percutaneous closure where live/real time three-dimensional transesophageal echocardiography provided incremental value over two-dimensional transesophageal echocardiography.

Utility of live/real time three-dimensional transesophageal echocardiography in the assessment and percutaneous intervention of bioprosthetic pulmonary valve stenosis.

Accurate echocardiographic evaluation of the pulmonary valve is technically difficult because of its close proximity to the left lung, which often limits decision making. Pulmonary valvotomy is the intervention of choice for symptomatic pulmonary valve stenosis, but fluoroscopy lacks appropriate real time anatomic detail. In this report, we present a case where direct imaging of the pulmonary valve with live/real time three-dimensional transesophageal echocardiography (3DTEE) aided in accurate evaluation and was then used to help guide and monitor successful valvuloplasty of a stenotic pulmonary valve bioprosthesis. We demonstrate that even in cases where two-dimensional (2D) evaluation of the pulmonary valve is difficult, the use of live/real time 3DTEE allows for accurate evaluation of bioprosthetic pulmonary valve structure and function, and enhances the precision and monitoring of percutaneous valvuloplasty.

Incremental value of three-dimensional echocardiography over the two-dimensional technique in the assessment of combined sinus of valsalva rupture into the right ventricle and adjacent perimembranous ventricular septal defect.

We describe the incremental value of live/real time three-dimensional (3D) echocardiography over the 2D technique in the assessment of ruptured right sinus of Valsalva into the right ventricle associated with an adjacent perimembranous ventricular septal defect in an elderly patient.

Live/real time three-dimensional transesophageal echocardiographic assessment of the spinal cord.

We present an adult patient in whom live/real time three-dimensional transesophageal echocardiography (3DTEE) provided incremental value in the assessment of the spinal cord as compared to two-dimensional transesophageal echocardiographic (2DTEE) findings published in the literature. It improved accurate identification and assessment of the anterior radiculomedullary spinal arteries which may have an important clinical application in monitoring for spinal cord ischemia during thoracic aortic surgery. Because the spinal cord and spinal canal could be examined using not only transverse but also coronal (frontal), sagittal, and oblique planes, 3DTEE further allowed for three-dimensional measurements of the dimensions and volumetric analysis of the visualized spinal cord and spinal canal. These may have implications in the assessment of spinal cord edema due to trauma and other conditions which result in increase in the size and volume of the spinal cord.

Recurrent dyspnea following multiple ablations for atrial fibrillation explained by the "stiff left atrial syndrome".

We present the case of a patient who underwent repeated ablations for atrial fibrillation and presented with recurrent dyspnea, elevated left atrial pressure with large V waves in the absence of mitral regurgitation. This case provides an example of "stiff left atrial syndrome" as has been described in patients with mitral valve replacement and only recently in patients with radiofrequency ablations for atrial fibrillation.

Successful percutaneous transvenous antegrade mitral valve-in-valve implantation.

We report a case of transcatheter valve-in-valve therapy performed on an 85-year-old man with severe mitral bioprosthetic valve dysfunction. He was a high risk candidate for conventional surgery and he underwent placement of the Melody transcatheter heart valve into the mitral bioprosthesis via the right femoral vein.

Persistent and Recurrent Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes.

BACKGROUND: Scarce data exist on the evolution of device-related thrombus (DRT) after left atrial appendage closure (LAAC). OBJECTIVES: This study sought to assess the incidence, predictors, and clinical impact of persistent and recurrent DRT in LAAC recipients. METHODS: Data were obtained from an international multicenter registry including 237 patients diagnosed with DRT after LAAC. Of these, 214 patients with a subsequent imaging examination after the initial diagnosis of DRT were included. Unfavorable evolution of DRT was defined as either persisting or recurrent DRT. RESULTS: DRT resolved in 153 (71.5%) cases and persisted in 61 (28.5%) cases. Larger DRT size (OR per 1-mm increase: 1.08; 95% CI: 1.02-1.15; P = 0.009) and female (OR: 2.44; 95% CI: 1.12-5.26; P = 0.02) were independently associated with persistent DRT. After DRT resolution, 82 (53.6%) of 153 patients had repeated device imaging, with 14 (17.1%) cases diagnosed with recurrent DRT. Overall, 75 (35.0%) patients had unfavorable evolution of DRT, and the sole predictor was average thrombus size at initial diagnosis (OR per 1-mm increase: 1.09; 95% CI: 1.03-1.16; P = 0.003), with an optimal cutoff size of 7 mm (OR: 2.51; 95% CI: 1.39-4.52; P = 0.002). Unfavorable evolution of DRT was associated with a higher rate of thromboembolic events compared with resolved DRT (26.7% vs 15.1%; HR: 2.13; 95% CI: 1.15-3.94; P = 0.02). CONCLUSIONS: About one-third of DRT events had an unfavorable evolution (either persisting or recurring), with a larger initial thrombus size (particularly >7 mm) portending an increased risk. Unfavorable evolution of DRT was associated with a 2-fold higher risk of thromboembolic events compared with resolved DRT.

Five-year follow-up of the Sirolimus-Eluting Stents vs Vascular Brachytherapy for Bare Metal In-Stent Restenosis (SISR) trial.

OBJECTIVES: The aim of this study was to evaluate the 5-year clinical safety and efficacy outcomes of patients treated for in-stent restenosis of bare-metal stents (BMSs). BACKGROUND: The SISR trial is a prospective, randomized trial that compared the safety and efficacy of sirolimus-eluting stent (SES) vs vascular brachytherapy (VBT) for the treatment of BMS in-stent restenosis. METHODS: A total of 384 patients with BMS in-stent restenosis were randomized to treatment with SES (n = 259) or VBT (n = 125) and were followed for 5 years. RESULTS: At 5 years, the rates of target lesion revascularization (TLR) had narrowed and were nonsignificant between the SES and VBT groups, with TLR rates of 24.7% and 31.2% (95% CI -16.3% to 2.8%, P = .179) respectively. Target vessel failure was 33.6% vs 36.8% (95% CI -13.5% to 6.7% P = .568) for SES compared with VBT. The rate of major adverse cardiac event at 5 years was 34.0% vs 36.8% (95% CI -13.1% to7.1%, P = .648) for the SES compared with VBT. There were no differences between SES and VBT in terms of survival free from TLR (72.9% vs 66.4%, log-rank P = .08) or from target vessel failure (64.4% vs 61.3%, log-rank P = .349). There were no significant differences in the rates of definite/probable stent thrombosis (5.9% vs 2.5%, 95% CI -7.9% to 1.3%, P = .182) between the 2 groups. CONCLUSIONS: At a 5-year follow-up, no differences in safety or efficacy outcomes were observed for treatment of BMS restenosis with SES vs VBT. There were no significant differences in survival free from TLR, target vessel revascularization, or major adverse cardiac events between the 2 groups at 5 years. Sirolimus-eluting stent is a viable treatment option compared with VBT for BMS restenosis.

Percutaneous therapeutic approaches to closure of cardiac pseudoaneurysms.

Cardiac and aortic pseudoaneurysms are rare complications following myocardial infarction or cardiac surgery. They are characterized by a contained cardiac or aortic rupture within surrounding tissue and have a high mortality rate if left untreated. Percutaneous treatment of cardiac pseudoaneurysms might be a feasible treatment option in patients who are at high risk of reoperative surgery. There is limited literature on the outcomes and the approaches to percutaneous treatment of these pseudoaneurysms. We review nine cases of cardiac and aortic pseudoaneurysms and percutaneous techniques for closure. Pseudoaneurysms were categorized anatomically as left ventricular posterior (posterobasal or posterolateral), left ventricular outflow tract, left ventricular apical, and ascending aortic pseudoaneurysms. Two patients with posterior pseudoaneurysms (one posterobasal treated with an Amplatzer Septal Occluder device, and one wide-mouthed posterolateral pseudoaneurysm which was not closed, are described. We further describe two left ventricular outflow tract pseudoaneurysms treated successfully with percutaneous coil embolization, one left ventricular apical pseudoaneurysm treated with coils, and three ascending aortic pseudoaneurysms treated with a septal occluder device or vascular plug. We review the technical approaches, device selection strategies, outcomes, and complications with these percutaneous treatment options. The size of the pseudoaneurysm dimensions of its neck and relative anatomy, particularly to the coronaries and valves, are critical issues to be addressed before percutaneous treatment of these pseudoaneurysms.

Percutaneous left ventricular assist device with TandemHeart for high-risk percutaneous coronary intervention: the Mayo Clinic experience.

BACKGROUND: In patients with poor left ventricular function and severe left main or multivessel coronary disease, coronary artery bypass grafting (CABG) surgery has been the preferred therapy. However, a number of these patients are either inoperable or poor surgical candidates due to comorbid conditions and previous cardiac surgical procedures. These patients are generally poor candidates for standard percutaneous coronary intervention (PCI) techniques. A hybrid PCI approach with hemodynamic support may be a viable strategy for these patients. We report our experience using the TandemHeart percutaneous left ventricular assist device during high-risk PCI. METHODS: Retrospective cross-sectional analysis of prospectively collected data in 54 patients undergoing high-risk PCI using the TandemHeart device for support. Hemodynamic and clinical data were collected and analyzed. RESULTS: Baseline clinical characteristics were as follows: mean age 72 ± 1.7 years, males 78%, median ejection fraction 20%, mean serum creatinine 1.6 ± 0.3 2 mg/dL, recent myocardial infarction 52%, COPD 33%, previous CABG 50%, diabetes mellitus 41%, and hypertension 83%. The median SYNTAX score was 33, and the median Jeopardy score was 10. The predicted surgical revascularization mortality was 13% by the Society for Thoracic Surgery risk score and 33% by Euroscore. There was a significant decrease in right and left heart pressures (P < 0.05) with a concomitant increase in the cardiac output from 4.7 to 5.7 L/min (P = 0.03) during TandemHeart support. Left main and multivessel PCI was performed in 62% of patients, and rotablation was used in 48%. Procedural success rate was 97%, whereas 30-day and 6 month survival were 90% and 87%, respectively. Major vascular complications occurred in 13% of cases. None of our patients developed contrast induced nephropathy or needed dialysis. CONCLUSIONS: High-risk PCI with percutaneous left ventricular support using TandemHeart is a viable therapeutic strategy for a select subset of patients at very high risk with standard percutaneous revascularization techniques.

Incidence, predictors, and outcomes of gastrointestinal bleeding in patients on dual antiplatelet therapy with aspirin and clopidogrel.

OBJECTIVES: The benefits of dual antiplatelet therapy are counterbalanced by the increased incidence of gastrointestinal (GI) complications. The aim of this study was to determine the frequency of GI bleeding, identify the predictors associated with the increased bleeding, and determine the short-term and long-term outcomes. METHODS: This was an observational, case-control cohort study carried out at the Albert Einstein Medical Center. It included all patients who had a drug-eluting stent implanted between May 2003 and April 2007. A total of 1852 patients were identified; of these 50 patients were readmitted for a GI bleed. A control group of 202 patients who did not have any evidence of GI bleeding were compared with the original group. All data were expressed as mean±SD. The baseline clinical characteristics between the 2 groups were compared using the t test and the Fisher exact test. Multivariate analysis was used to determine the predictors of GI bleeding. RESULTS: The rate of GI bleeding was 2.7%. The mean age in the group with GI bleeding was 70.9±12.2 years, whereas in the group without GI bleeding it was 66.5±12.8 years (P<0.05). The majority of the patients presented with melena (40%). Gastritis and gastric ulcers were the most common findings seen in 49% of the patients on endoscopy. On multivariate logistic regression analysis, a history of GI bleeding was the most important independent predictor of future GI bleeding (P<0.001), whereas the use of statins was found to be protective (95% confidence interval, 0.13-0.48; P<0.001) against future GI bleeding. The 30-day mortality rate in the GI bleeding and control groups was 3.7% and 0%, respectively (P<0.01), whereas in the corresponding 1 year the mortality rate was 18.9% and 0%, respectively (P<0.001). CONCLUSIONS: The rate of GI bleeding in patients on dual antiplatelet therapy is low. Earlier history of GI bleeding is the most significant multivariate predictor of future GI bleeding whereas statins seemed to be protective. Patients with GI bleeding have increased short-term and long-term mortality; thereby a history of earlier GI bleeding needs to be assessed carefully before starting dual antiplatelet therapy. This may play a vital role in the selection of therapeutic strategies in these patients.