Wesley Pedersen - Academia.edu (original) (raw)

Papers by Wesley Pedersen

Research paper thumbnail of 4-Year Results of a Randomized Controlled Trial of Percutaneous Repair Versus Surgery for Mitral Regurgitation

Journal of the American College of Cardiology, 2013

This study sought to evaluate 4-year outcomes of percutaneous repair versus surgery for mitral re... more This study sought to evaluate 4-year outcomes of percutaneous repair versus surgery for mitral regurgitation. Background Transcatheter therapies are being developed to treat valvular heart disease. In the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II trial, treatment of mitral valve regurgitation (MR) with a novel percutaneous device was compared with surgery and showed superior safety, but less reduction in MR at 1 year overall. We report the 4-year outcomes from the EVEREST II trial. Methods Patients with grade 3þ or 4þ MR were randomly assigned to percutaneous repair with the MitraClip (Abbott, Menlo Park, California) device or conventional mitral valve surgery in a 2:1 ratio (184:95). Patients prospectively consented to 5 years of follow-up. Results At 4 years, the rate of the composite endpoint of freedom from death, surgery, or 3þ or 4þ MR in the intention-to-treat population was 39.8% versus 53.4% in the percutaneous repair group and surgical groups, respectively (p ¼ 0.070). Rates of death were 17.4% versus 17.8% (p ¼ 0.914), and 3þ or 4þ MR was present in 21.7% versus 24.7% (p ¼ 0.745) at 4 years of follow-up, respectively. Surgery for mitral valve dysfunction, however, occurred in 20.4% versus 2.2% (p < 0.001) at 1 year and 24.8% versus 5.5% (p < 0.001) at 4 years. Conclusions Patients treated with percutaneous repair of the mitral valve more commonly required surgery to treat residual MR; however, after the first year of follow-up, there were few surgeries required after either percutaneous or surgical treatment and no difference in the prevalence of moderate-severe and severe MR or mortality at 4 years.

Research paper thumbnail of A Perspective on Needs Identification for Successful Cardiovascular Device Innovation

Journal of Biotechnology and its Applications

A compelling “need” identification is essential prior to initiating the lengthy, demanding and of... more A compelling “need” identification is essential prior to initiating the lengthy, demanding and often frustrating pathway necessary for cardiovascular device innovation and development. Over the past few decades both iterative and transformational treatments have been especially profound in cardiovascular interventional and surgical approaches which have necessitated innovation in devices to bring these novel approaches to fruition. Stakeholders in the development of such devices have included amongst others, clinicians, patients and institutions. Given the numerous hurdles for medical device development including the need for multidisciplinary teams, establishing intellectual property portfolios, conducting market in tandem with academic research, funding, identifying regulatory and reimbursement strategies, a rigorous process for needs verification is mandatory. This vital first step needs to be methodical and is the topic of brief discussion in this perspective manuscript.

Research paper thumbnail of Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients

JAMA Cardiology

ImportanceIn patients with severe aortic valve stenosis at intermediate surgical risk, transcathe... more ImportanceIn patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited.ObjectiveTo report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial.Design, Setting, and ParticipantsSURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August ...

Research paper thumbnail of Contemporary Reasons and Clinical Outcomes for Patients With Severe, Symptomatic Aortic Stenosis Not Undergoing Aortic Valve Replacement

Circulation: Cardiovascular Interventions, 2018

Background: Although aortic valve replacement (AVR) can be lifesaving, many patients with symptom... more Background: Although aortic valve replacement (AVR) can be lifesaving, many patients with symptomatic aortic stenosis do not undergo appropriate therapy. This study sought to examine the characteristics, outcomes, and reasons for not pursuing AVR in a contemporary cohort. Methods and Results: We examined 548 patients with severe, symptomatic aortic stenosis not treated with AVR through March 2017. Patients were grouped according to AVR appropriateness based on the presence of medical futility. Demographics, rationale for no AVR therapy, and outcomes were assessed. There were 359 (65.5%) potentially appropriate candidates for AVR and 189 (34.5%) others patients with futility. Among potentially appropriate patients, 62.1% had severe symptoms, 74.4% had not been referred for AVR, and 40.1% were low risk. Patient refusal was common (54.6%), with incorrect symptom assignment or aortic stenosis severity classification accounting for nearly all other explanations. Compared with patients wi...

Research paper thumbnail of Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients

Heart (British Cardiac Society), Jan 4, 2018

This study evaluates the 5-year clinical outcomes of transcatheter mitral valve (MV) repair with ... more This study evaluates the 5-year clinical outcomes of transcatheter mitral valve (MV) repair with the MitraClip device in patients at high risk for MV surgery treated in the Endovascular Valve Edge-to-Edge Repair (EVEREST) II High Risk Study (HRS). Patients with mitral regurgitation (MR) 3+ or 4+ and predicted surgical mortality risk ≥12% or surgeon assessment based on prespecified high-risk factors were enrolled. Patients prospectively consented to 5 years of follow-up. At 5 years, clinical follow-up was achieved in 90% of 78 enrolled patients. The rate of postprocedural adverse events declined from 30 days to 1 year follow-up and was stable thereafter through 5 years. Two patients (2.6%) developed mitral stenosis (MS). Two patients underwent MV surgery, including one due to MS. A total of 42 deaths were reported through 5 years. Effectiveness measures at 5 years showed reductions in MR severity to ≤2+ in 75% of patients (p=0.0107), left ventricular (LV) end-diastolic volume (-38.2 ...

Research paper thumbnail of Improvement in Aortic Valve Area in Patients With Aortic Stenosis Through Use of a New "Hourglass-Shaped" Valvuloplasty Balloon

The Journal of invasive cardiology, 2017

The study aim was to assess the effect of hourglass-shaped V8 and TAV8 balloons (InterValve, Inc)... more The study aim was to assess the effect of hourglass-shaped V8 and TAV8 balloons (InterValve, Inc) on aortic valve area (AVA) and other outcomes in patients with severe aortic stenosis undergoing balloon aortic valvuloplasty (BAV). BAV has re-emerged with transcatheter therapy. Cylindrical balloons have been the device of choice despite limitations. The hourglass-shaped balloons, with shorter, broader segments separated by a narrowed waist, permit enhanced fixation and better leaflet opening without annular or sinotubular compromise. We compared outcomes of InterValve balloon use in patients undergoing BAV with outcomes of cylindrical balloon use in patients from a BAV database. Patients were propensity matched by age, gender, baseline AVA, left ventricular ejection fraction, and Society of Thoracic Surgeons mortality risk score. Endpoints included change in AVA and aortic insufficiency (AI) by echocardiography, new permanent pacemaker (PPM) implantation, and major adverse events (ie...

Research paper thumbnail of Patterns and Predictors of Stroke Volume Change with Transcatheter Aortic Valve Replacement for Low-Gradient Aortic Stenosis and Normal Ejection Fraction

Journal of the American College of Cardiology, 2016

Stroke volume index (SVI) is powerful predictor of prognosis in patients with severe aortic steno... more Stroke volume index (SVI) is powerful predictor of prognosis in patients with severe aortic stenosis and normal ejection fraction. However, there is a paucity of data on patterns and predictors of improvement in SVI following transcatheter aortic valve replacement (TAVR). We examined 114 patients

Research paper thumbnail of Prospective Evaluation of the Eyeball Test for Assessing Frailty in Patients With Valvular Heart Disease

Journal of the American College of Cardiology, Dec 27, 2016

Research paper thumbnail of The right atrium and tricuspid annulus are cardinal structures in tricuspid regurgitation with or without pulmonary hypertension

International journal of cardiology, Jan 9, 2016

Right heart structural abnormalities occur in both tricuspid regurgitation (TR) and pulmonary hyp... more Right heart structural abnormalities occur in both tricuspid regurgitation (TR) and pulmonary hypertension (PH). They may occur independently or together, but their joint effects on cardiac structure are incompletely described. This study examined the interactions of TR severity and PH on right heart structural changes. The study evaluated 455 patients undergoing both echocardiography and CT angiography (CTA). Cases were divided into 3 groups by TR severity: trace (n=217), mild (n=174), and significant (moderate or severe, n=64). Each TR level was subdivided into two groups by PH absent or present. Cardiac structural measurements included tricuspid annulus area (TAA), right atrial (RA) and right ventricular volume (RV) indexed to body surface area. Analysis by TR and PH showed that indexed RA Volume and TAA were very sensitive to TR severity. RA volume was most affected by pulmonary hypertension when TR was trace or mild, while PH had less effect on TAA. In significant TR, neither R...

Research paper thumbnail of Benefit of Guideline Adherence for Serial Evaluations in Patients with Severe Aortic Stenosis

Journal of the American College of Cardiology, 2016

Background: For asymptomatic patients with severe aortic stenosis (AS), national guidelines empir... more Background: For asymptomatic patients with severe aortic stenosis (AS), national guidelines empirically recommend serial evaluations every 6 to 12 months. However, the benefit of this clinical monitoring is unknown. Methods: We examined 200 patients with asymptomatic severe AS (81±12 yrs; 55% women). Adherence to practice guidelines was defined as serial evaluations occurring every 12±3mos until aortic valve replacement (AVR) or death. Comparisons were performed for patients with and without guideline adherence for adverse clinical events and survival. Results: There were no differences with respect to age, morbidities, and aortic valve hemodynamics for patients with (n=140) and without guideline adherence (n=60). Over a 3-year follow-up, AVR (surgical or catheter-based) was performed more frequently in patients with guideline adherence (47.2% vs. 18.3%; p=0.001). Adherent patients also demonstrated greater survival free of heart failure hospitalization in comparison to those without adherence (59.2% [95% CI, 50.4% to 67.9%] vs. 52.6% [39.8% to 61.3%]; p=0.02; Figure). There was no difference in mortality nor inpatient variable costs between those with and without guideline adherence. Conclusions: Adherence to practice guidelines for serial evaluations in patients with asymptomatic, severe AS is associated with greater rates of AVR and a lower incidence of heart failure hospitalization. These beneficial outcomes occur without an impact on survival nor on hospitalization costs.

Research paper thumbnail of The Tendyne Early Feasibility Trial of Transcatheter Mitral Valve Implantation

Journal of the American College of Cardiology, 2016

Background: Severe mitral regurgitation (MR) is associated with a high morbidity and a 5yr mortal... more Background: Severe mitral regurgitation (MR) is associated with a high morbidity and a 5yr mortality >50%. Options for high surgical risk patients are limited. Transcatheter mitral valve implantation (TMVI) is a promising new approach for these patients. Objective: To evaluate the safety and efficacy of Tendyne TMVI in patients with severe MR at high risk for surgery. Methods: The Tendyne Early Feasibility trial is a prospective, open-label, non-randomised trial evaluating the safety and efficacy of a novel mitral prosthesis. The device consists of a D-shaped outer frame, a circular inner frame, and a porcine pericardial trileaflet valve that is deployed within the mitral annulus and tethered to the apex of the left ventricle (LV). The valve can be recaptured, repositioned, and if necessary, fully retrieved. Up to 30 patients with severe, symptomatic MR will be included in the trial. Patients are ineligible for the trial if they have LV ejection fraction (LVEF) <25%, LV end-diastolic dimension >7.0cm, prior mitral or aortic valve surgery, severe coronary disease, heart failure requiring inotropic support, severe tricuspid regurgitation or severe RV dysfunction. The primary efficacy endpoint is MR grade <2 at 90days. The primary safety endpoint is freedom from cardiovascular death, stroke, myocardial infarction, or surgery for valve-related dysfunction. Results: To date, 12 patients (all male; age 75.3+3.4yrs) have been treated at two study sites. All patients had severe (4+) MR (11 secondary, 1 mixed pathology), and all were symptomatic (NYHA class II-IV). The LVEF was 40.2+11.8% (range 30-61%) and the mean STS score was 6.5 (range 2-16). In 11 patients, the device was deployed with no residual MR, no paravalvular leak, and no adverse events. In one patient, device deployment resulted in LV outflow obstruction and hypotension. It was removed without adverse sequelae. All patients were discharged alive with a length of stay ranging from 5-12days. Conclusions: Early results from the Feasibility Trial suggest that the Tendyne prosthesis can be used to abolish MR with a low periprocedural complication rate in a high-risk population. Thirty-day outcomes for all enrolled patients will be presented.

Research paper thumbnail of Initial findings using the V8 hourglass-shaped valvuloplasty balloon for postdilatation in treating paravalvular leaks associated with transcatheter self-expanding aortic valve prosthesis

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, Jan 6, 2016

The aim of this study was to assess the effect of a novel hourglass-shaped balloon on reduction o... more The aim of this study was to assess the effect of a novel hourglass-shaped balloon on reduction of paravalvular leak (PVL) in patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding prostheses. An important limitation of TAVR compared with surgical aortic valve replacement remains the higher incidence of PVL. A commonly used strategy to treat PVL is balloon postdilatation (BPD); however, the optimal technique for treating PVL after TAVR is unknown. We examined consecutive patients with severe, symptomatic aortic stenosis who underwent TAVR with the Medtronic CoreValve followed by BPD with an InterValve V8 balloon for PVL grade ≥2+. Data from echocardiographic, multidetector computed tomographic, and angiographic images were reviewed. The primary endpoint was successful reduction in PVL to grade 1+ or less as assessed by intraprocedural echocardiography. Eleven patients were studied (median age, 82 years; 64% female). Ten patients (91%) demonstrated succ...

Research paper thumbnail of TCT-842 Embolic Particles Show Surprising Size Dependent Predilection for Cerebral versus Peripheral Arteries: Results from Computational Fluid Dynamic Modeling

Journal of the American College of Cardiology, 2012

Background: Transcatheter aortic valve implantation (TAVI) has been established as a reliable alt... more Background: Transcatheter aortic valve implantation (TAVI) has been established as a reliable alternative treatment in high risk patients, resulting in symptoms and left ventricle function improvement. The aim of this study was to evaluate the impact of TAVI on early recovery of left ventricle function using echocardiographic left ventricular deformation parameters and to define their possible correlation with myocardial function. Methods: 16 patients (6 females, 81 Ϯ 5 years; EuroScore: 24 Ϯ 4%) with severe aortic stenosis but free of significant coronary artery disease, who underwent TAVI with the CoreValve aortic prosthesis were studied. Conventional 2D and 2D-speckle echocardiography analysis were performed pre-interventional and at discharge. Deformation indices of left ventricle, such as Peak Systolic Longitudinal Strain (PSLS) and Torsion (apex-basal rotation) were determined by speckle tracking echocardiography using commercially available computer software. Besides, Left Ventricle Ejection Fraction (LVEF), calculated with Simpson method, was evaluated at one month follow-up. Results: In all patients at discharge, a reduction of transaortic peak pressure gradient (pϽ0.0005), of mean pressure gradient (pϽ0.0001) was observed, with a concomitant increase in aortic valve area (pϽ0.0001). In addition, 2D speckle analysis showed a significant improvement of PSLS at discharge (Ϫ10.6Ϯ2.8 vs Ϫ12.8Ϯ3.9%, pϭ0.008). Similarly, left ventricle Torsion was significantly increased comparing to pre-implantation values (7.2Ϯ5.1 vs 11.5Ϯ6, pϭ0.015). However, overall LVEF did not change (51.4Ϯ8.8 vs 50.9Ϯ8.1%; pϭ0.55). During follow-up, a strong correlation was found between discharge PSLS and one month LVEF, with greater longitudinal deformation (PSLS) associated with higher LVEF (pϭ0.03). However, one month LVEF compared to discharge, indicated a trend for improvement (pϾ0.05), but not statistically significant. Conclusions: Deformation indices of PSLS and Torsion are able to detect early improvement of left ventricle function after TAVI regardless LVEF alteration. Moreover, PSLS seems to predict LVEF in one month. Larger studies with long term follow-up are required.

Research paper thumbnail of Cardiogenic Shock: No Longer a Contraindication to Therapeutic Hypothermia in Survivors of Cardiac Arrest

Journal of the American College of Cardiology, 2012

Background: Therapeutic hypothermia (TH) is neuroprotective and increases survival in cardiac arr... more Background: Therapeutic hypothermia (TH) is neuroprotective and increases survival in cardiac arrest survivors. Cardiac arrest is often seen in the setting of ST-elevation myocardial infarction (STEMI), and cardiogenic shock (CS) is a known poor prognostic factor. Methods: From Feb 2006 to July 2011, 252 consecutive cardiac arrest patients who remained comatose following return of spontaneous circulation were enrolled in a TH protocol, integrated into a regional STEMI transfer network. Patients were treated regardless of past medical history, initial rhythm or hemodynamic status. The aim of this study was to determine if there were any predictors of CS in this population and their effect on morbidity and mortality. Results: Of the 252 patients, 92 (36.5%) were in CS. Survival with favorable neurologic outcome (CPC 1 or 2) was poorer in CS patients than no CS patients, 33/92 (35.9%) vs 83/160 (51.9%), p=0.014. Patients in CS were older 65.5 vs 61.5 years p=0.02 and had a higher incidence of preexisting cardiomyopathy (CM) 41/92 (44.6%) vs 41/160 (25.6%) p=0.002 and concurrent STEMI 43/92 (46.7%) vs 44/160 (27.5%) p=0.002. Ischemic CM was the most common type 34/41 (83.0%). The odds ratio of CS in patients with pre-existing CM was OR=2.33 (1.36, 4.02). The odds ratio of CS in patients with concurrent STEMI was OR=2.31 (1.35, 3.96). There was no statistical difference in gender, initial rhythm, transfer distance, history of CAD, HTN, or CHF between patients in CS versus those without CS. There was a trend of lower survival with CPC 1/2 in pre-existing CM patients than those without 12/41 (29.3%) vs 21/51 (41.2%) p=0.24. There was a trend of higher survival with CPC 1/2 in patients in CS and concurrent STEMI than CS alone 19/43 (44.2%) vs 14/49 (28.6%) p=0.12. Conclusion: Pre-existing CM and concurrent STEMI are associated with higher incidence of CS. Prior CM is common among those with CS. CS has an unexpectedly favorable outcome with TH. TH should be the standard of care for unresponsive cardiac arrest patients in CS.

Research paper thumbnail of Cardiac Chamber and Tricuspid Annulus Relations in Tricuspid Regurgitation Three-Dimensional Computed Tomographic Analysis

Journal of the American College of Cardiology, 2014

background: Tricuspid regurgitation (TR) is a potent determinant of long term prognosis in patien... more background: Tricuspid regurgitation (TR) is a potent determinant of long term prognosis in patients with valvular heart disease. Yet relationships among the tricuspid valve (TV) and cardiac chamber anatomy are incompletely characterized. As percutaneous TV repair/replacement is under development, precise definition of TV and associated chamber anatomy is assuming great importance. This study evaluated tricuspid and cardiac chambers using echocardiography and three-dimensional computed tomography (3DCT). methods: Echocardiography and 3DCT image data were analyzed in 633 patients. Patients were divided into 2 groups according to echocardiographic TR severity as no TR (Group 1, TR none or mild, n=573) and significant TR (Group 2, TR significant, moderate or severe, n=60). Tricuspid annulus area (TAA) and cardiac chamber dimensions were measured at ventricular mid-diastole. results: Differences between groups included age >75 years, presence of left valve disease (LVD) and atrial fibrillation (AF). Patients with significant TR differed by univariate analysis in normalized TAA (n-TAA) and in all cardiac chamber indices (right atrial volume index (RAi), left atrial volume index (LAi), right ventricle volume index (RVi) and left ventricle volume index (LVi)). Multivariate analysis found that n-TAA, RVi, age >75 years, female gender, LVD and AF were independent predictors of significant TR. Optimal threshold values differentiating patients with significant TR by receiver-operating characteristic analysis were: n-TAA (cut off value, area under the curve) 804 mm2/m2 (0.835), RAi 64 ml/m2 (0.814), RVi 73 ml/ m2 (0.717), LAi 61 ml/m2 (0.700) and LVi 71ml/m2 (0.602). conclusions: TR is associated with significant enlargement of all cardiac chambers. Threshold values for significant TR can be defined statically and may assist with determining need for TR intervention as percutaneous therapies become available.

Research paper thumbnail of Effectiveness of Transcatheter Reduction of Significant Mitral Regurgitation in High Surgical Risk Patients with Mitraclip: Final 5 Year Results of the Everest II High Risk Registry

Journal of the American College of Cardiology, 2014

Research paper thumbnail of Relationships Between Tricuspid Regurgitation, Elevated Pulmonary Pressure and Right Heart Remodeling

Journal of the American College of Cardiology, 2014

The study evaluated 455 patients with both echocardiography and 3-dimensional computed tomography... more The study evaluated 455 patients with both echocardiography and 3-dimensional computed tomography (CT). Cases were divided into 3 groups by TR severity: Group I, trace TR, n=217; Group 2, mild TR, n=174, and Group 3, moderate/severe TR n=64. Each TR group was subdivided into 2 subgroups (subgroup a: PH absent and subgroup b: PH present) by the presence or absence of PH, defined as PAP >40 mmHg. Six groups resulted. In each group measurements were made of the tricuspid annulus area and index (TAA), right atrium volume and index (RA) and right ventricular volume (RV) and index using CT images.

Research paper thumbnail of Contemporary Reasons for Medical Rather Than Surgical Therapy in Patients with Symptomatic Aortic Stenosis

Journal of the American College of Cardiology, 2014

background: There has been recent increase in the therapies available for treatment of symptomati... more background: There has been recent increase in the therapies available for treatment of symptomatic aortic stenosis (SAS). We examined the current reasons for lack of aortic valve replacement (AVR) in patients with severe SAS and indications for surgical therapy. methods: We identified 131 patients (mean age, 80.2 ± 9.8 years; 52.6% men; mean STS score, 9.7% ± 4.6%) seen at our institution in 2012 for severe SAS as determined via transthoracic echocardiography. Patient demographics, comorbidities, echocardiographic data, clinical events, and reasons for medical therapy rather than AVR were examined.

Research paper thumbnail of Paravalvular leak after transcatheter aortic valve implantation: trading one disease for another?

Expert Review of Cardiovascular Therapy, 2014

Research paper thumbnail of Exclusion of atrial thrombus by transesophageal echocardiography does not preclude embolism after cardioversion of atrial fibrillation. A multicenter study

Circulation, 1994

BACKGROUND Transesophageal echocardiography (TEE) has been used recently to detect atrial thrombi... more BACKGROUND Transesophageal echocardiography (TEE) has been used recently to detect atrial thrombi before cardioversion of atrial arrhythmias. It has been assumed that embolic events after cardioversion result from embolism of preexisting atrial thrombi that are accurately detected by TEE. This study examined the clinical and echocardiographic findings in patients with embolism after cardioversion of atrial fibrillation despite exclusion of atrial thrombi by TEE. METHODS AND RESULTS Clinical and echocardiographic data in 17 patients with embolic events after TEE-guided electrical (n = 16) or pharmacological (n = 1) cardioversion were analyzed. All 17 patients had nonvalvular atrial fibrillation, including four patients with lone atrial fibrillation. TEE before cardioversion showed left atrial spontaneous echo contrast in five patients and did not show atrial thrombus in any patient. Cardioversion resulted in return to sinus rhythm without immediate complication in all patients. Thirt...

Research paper thumbnail of 4-Year Results of a Randomized Controlled Trial of Percutaneous Repair Versus Surgery for Mitral Regurgitation

Journal of the American College of Cardiology, 2013

This study sought to evaluate 4-year outcomes of percutaneous repair versus surgery for mitral re... more This study sought to evaluate 4-year outcomes of percutaneous repair versus surgery for mitral regurgitation. Background Transcatheter therapies are being developed to treat valvular heart disease. In the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II trial, treatment of mitral valve regurgitation (MR) with a novel percutaneous device was compared with surgery and showed superior safety, but less reduction in MR at 1 year overall. We report the 4-year outcomes from the EVEREST II trial. Methods Patients with grade 3þ or 4þ MR were randomly assigned to percutaneous repair with the MitraClip (Abbott, Menlo Park, California) device or conventional mitral valve surgery in a 2:1 ratio (184:95). Patients prospectively consented to 5 years of follow-up. Results At 4 years, the rate of the composite endpoint of freedom from death, surgery, or 3þ or 4þ MR in the intention-to-treat population was 39.8% versus 53.4% in the percutaneous repair group and surgical groups, respectively (p ¼ 0.070). Rates of death were 17.4% versus 17.8% (p ¼ 0.914), and 3þ or 4þ MR was present in 21.7% versus 24.7% (p ¼ 0.745) at 4 years of follow-up, respectively. Surgery for mitral valve dysfunction, however, occurred in 20.4% versus 2.2% (p < 0.001) at 1 year and 24.8% versus 5.5% (p < 0.001) at 4 years. Conclusions Patients treated with percutaneous repair of the mitral valve more commonly required surgery to treat residual MR; however, after the first year of follow-up, there were few surgeries required after either percutaneous or surgical treatment and no difference in the prevalence of moderate-severe and severe MR or mortality at 4 years.

Research paper thumbnail of A Perspective on Needs Identification for Successful Cardiovascular Device Innovation

Journal of Biotechnology and its Applications

A compelling “need” identification is essential prior to initiating the lengthy, demanding and of... more A compelling “need” identification is essential prior to initiating the lengthy, demanding and often frustrating pathway necessary for cardiovascular device innovation and development. Over the past few decades both iterative and transformational treatments have been especially profound in cardiovascular interventional and surgical approaches which have necessitated innovation in devices to bring these novel approaches to fruition. Stakeholders in the development of such devices have included amongst others, clinicians, patients and institutions. Given the numerous hurdles for medical device development including the need for multidisciplinary teams, establishing intellectual property portfolios, conducting market in tandem with academic research, funding, identifying regulatory and reimbursement strategies, a rigorous process for needs verification is mandatory. This vital first step needs to be methodical and is the topic of brief discussion in this perspective manuscript.

Research paper thumbnail of Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients

JAMA Cardiology

ImportanceIn patients with severe aortic valve stenosis at intermediate surgical risk, transcathe... more ImportanceIn patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited.ObjectiveTo report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial.Design, Setting, and ParticipantsSURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August ...

Research paper thumbnail of Contemporary Reasons and Clinical Outcomes for Patients With Severe, Symptomatic Aortic Stenosis Not Undergoing Aortic Valve Replacement

Circulation: Cardiovascular Interventions, 2018

Background: Although aortic valve replacement (AVR) can be lifesaving, many patients with symptom... more Background: Although aortic valve replacement (AVR) can be lifesaving, many patients with symptomatic aortic stenosis do not undergo appropriate therapy. This study sought to examine the characteristics, outcomes, and reasons for not pursuing AVR in a contemporary cohort. Methods and Results: We examined 548 patients with severe, symptomatic aortic stenosis not treated with AVR through March 2017. Patients were grouped according to AVR appropriateness based on the presence of medical futility. Demographics, rationale for no AVR therapy, and outcomes were assessed. There were 359 (65.5%) potentially appropriate candidates for AVR and 189 (34.5%) others patients with futility. Among potentially appropriate patients, 62.1% had severe symptoms, 74.4% had not been referred for AVR, and 40.1% were low risk. Patient refusal was common (54.6%), with incorrect symptom assignment or aortic stenosis severity classification accounting for nearly all other explanations. Compared with patients wi...

Research paper thumbnail of Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients

Heart (British Cardiac Society), Jan 4, 2018

This study evaluates the 5-year clinical outcomes of transcatheter mitral valve (MV) repair with ... more This study evaluates the 5-year clinical outcomes of transcatheter mitral valve (MV) repair with the MitraClip device in patients at high risk for MV surgery treated in the Endovascular Valve Edge-to-Edge Repair (EVEREST) II High Risk Study (HRS). Patients with mitral regurgitation (MR) 3+ or 4+ and predicted surgical mortality risk ≥12% or surgeon assessment based on prespecified high-risk factors were enrolled. Patients prospectively consented to 5 years of follow-up. At 5 years, clinical follow-up was achieved in 90% of 78 enrolled patients. The rate of postprocedural adverse events declined from 30 days to 1 year follow-up and was stable thereafter through 5 years. Two patients (2.6%) developed mitral stenosis (MS). Two patients underwent MV surgery, including one due to MS. A total of 42 deaths were reported through 5 years. Effectiveness measures at 5 years showed reductions in MR severity to ≤2+ in 75% of patients (p=0.0107), left ventricular (LV) end-diastolic volume (-38.2 ...

Research paper thumbnail of Improvement in Aortic Valve Area in Patients With Aortic Stenosis Through Use of a New "Hourglass-Shaped" Valvuloplasty Balloon

The Journal of invasive cardiology, 2017

The study aim was to assess the effect of hourglass-shaped V8 and TAV8 balloons (InterValve, Inc)... more The study aim was to assess the effect of hourglass-shaped V8 and TAV8 balloons (InterValve, Inc) on aortic valve area (AVA) and other outcomes in patients with severe aortic stenosis undergoing balloon aortic valvuloplasty (BAV). BAV has re-emerged with transcatheter therapy. Cylindrical balloons have been the device of choice despite limitations. The hourglass-shaped balloons, with shorter, broader segments separated by a narrowed waist, permit enhanced fixation and better leaflet opening without annular or sinotubular compromise. We compared outcomes of InterValve balloon use in patients undergoing BAV with outcomes of cylindrical balloon use in patients from a BAV database. Patients were propensity matched by age, gender, baseline AVA, left ventricular ejection fraction, and Society of Thoracic Surgeons mortality risk score. Endpoints included change in AVA and aortic insufficiency (AI) by echocardiography, new permanent pacemaker (PPM) implantation, and major adverse events (ie...

Research paper thumbnail of Patterns and Predictors of Stroke Volume Change with Transcatheter Aortic Valve Replacement for Low-Gradient Aortic Stenosis and Normal Ejection Fraction

Journal of the American College of Cardiology, 2016

Stroke volume index (SVI) is powerful predictor of prognosis in patients with severe aortic steno... more Stroke volume index (SVI) is powerful predictor of prognosis in patients with severe aortic stenosis and normal ejection fraction. However, there is a paucity of data on patterns and predictors of improvement in SVI following transcatheter aortic valve replacement (TAVR). We examined 114 patients

Research paper thumbnail of Prospective Evaluation of the Eyeball Test for Assessing Frailty in Patients With Valvular Heart Disease

Journal of the American College of Cardiology, Dec 27, 2016

Research paper thumbnail of The right atrium and tricuspid annulus are cardinal structures in tricuspid regurgitation with or without pulmonary hypertension

International journal of cardiology, Jan 9, 2016

Right heart structural abnormalities occur in both tricuspid regurgitation (TR) and pulmonary hyp... more Right heart structural abnormalities occur in both tricuspid regurgitation (TR) and pulmonary hypertension (PH). They may occur independently or together, but their joint effects on cardiac structure are incompletely described. This study examined the interactions of TR severity and PH on right heart structural changes. The study evaluated 455 patients undergoing both echocardiography and CT angiography (CTA). Cases were divided into 3 groups by TR severity: trace (n=217), mild (n=174), and significant (moderate or severe, n=64). Each TR level was subdivided into two groups by PH absent or present. Cardiac structural measurements included tricuspid annulus area (TAA), right atrial (RA) and right ventricular volume (RV) indexed to body surface area. Analysis by TR and PH showed that indexed RA Volume and TAA were very sensitive to TR severity. RA volume was most affected by pulmonary hypertension when TR was trace or mild, while PH had less effect on TAA. In significant TR, neither R...

Research paper thumbnail of Benefit of Guideline Adherence for Serial Evaluations in Patients with Severe Aortic Stenosis

Journal of the American College of Cardiology, 2016

Background: For asymptomatic patients with severe aortic stenosis (AS), national guidelines empir... more Background: For asymptomatic patients with severe aortic stenosis (AS), national guidelines empirically recommend serial evaluations every 6 to 12 months. However, the benefit of this clinical monitoring is unknown. Methods: We examined 200 patients with asymptomatic severe AS (81±12 yrs; 55% women). Adherence to practice guidelines was defined as serial evaluations occurring every 12±3mos until aortic valve replacement (AVR) or death. Comparisons were performed for patients with and without guideline adherence for adverse clinical events and survival. Results: There were no differences with respect to age, morbidities, and aortic valve hemodynamics for patients with (n=140) and without guideline adherence (n=60). Over a 3-year follow-up, AVR (surgical or catheter-based) was performed more frequently in patients with guideline adherence (47.2% vs. 18.3%; p=0.001). Adherent patients also demonstrated greater survival free of heart failure hospitalization in comparison to those without adherence (59.2% [95% CI, 50.4% to 67.9%] vs. 52.6% [39.8% to 61.3%]; p=0.02; Figure). There was no difference in mortality nor inpatient variable costs between those with and without guideline adherence. Conclusions: Adherence to practice guidelines for serial evaluations in patients with asymptomatic, severe AS is associated with greater rates of AVR and a lower incidence of heart failure hospitalization. These beneficial outcomes occur without an impact on survival nor on hospitalization costs.

Research paper thumbnail of The Tendyne Early Feasibility Trial of Transcatheter Mitral Valve Implantation

Journal of the American College of Cardiology, 2016

Background: Severe mitral regurgitation (MR) is associated with a high morbidity and a 5yr mortal... more Background: Severe mitral regurgitation (MR) is associated with a high morbidity and a 5yr mortality >50%. Options for high surgical risk patients are limited. Transcatheter mitral valve implantation (TMVI) is a promising new approach for these patients. Objective: To evaluate the safety and efficacy of Tendyne TMVI in patients with severe MR at high risk for surgery. Methods: The Tendyne Early Feasibility trial is a prospective, open-label, non-randomised trial evaluating the safety and efficacy of a novel mitral prosthesis. The device consists of a D-shaped outer frame, a circular inner frame, and a porcine pericardial trileaflet valve that is deployed within the mitral annulus and tethered to the apex of the left ventricle (LV). The valve can be recaptured, repositioned, and if necessary, fully retrieved. Up to 30 patients with severe, symptomatic MR will be included in the trial. Patients are ineligible for the trial if they have LV ejection fraction (LVEF) <25%, LV end-diastolic dimension >7.0cm, prior mitral or aortic valve surgery, severe coronary disease, heart failure requiring inotropic support, severe tricuspid regurgitation or severe RV dysfunction. The primary efficacy endpoint is MR grade <2 at 90days. The primary safety endpoint is freedom from cardiovascular death, stroke, myocardial infarction, or surgery for valve-related dysfunction. Results: To date, 12 patients (all male; age 75.3+3.4yrs) have been treated at two study sites. All patients had severe (4+) MR (11 secondary, 1 mixed pathology), and all were symptomatic (NYHA class II-IV). The LVEF was 40.2+11.8% (range 30-61%) and the mean STS score was 6.5 (range 2-16). In 11 patients, the device was deployed with no residual MR, no paravalvular leak, and no adverse events. In one patient, device deployment resulted in LV outflow obstruction and hypotension. It was removed without adverse sequelae. All patients were discharged alive with a length of stay ranging from 5-12days. Conclusions: Early results from the Feasibility Trial suggest that the Tendyne prosthesis can be used to abolish MR with a low periprocedural complication rate in a high-risk population. Thirty-day outcomes for all enrolled patients will be presented.

Research paper thumbnail of Initial findings using the V8 hourglass-shaped valvuloplasty balloon for postdilatation in treating paravalvular leaks associated with transcatheter self-expanding aortic valve prosthesis

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, Jan 6, 2016

The aim of this study was to assess the effect of a novel hourglass-shaped balloon on reduction o... more The aim of this study was to assess the effect of a novel hourglass-shaped balloon on reduction of paravalvular leak (PVL) in patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding prostheses. An important limitation of TAVR compared with surgical aortic valve replacement remains the higher incidence of PVL. A commonly used strategy to treat PVL is balloon postdilatation (BPD); however, the optimal technique for treating PVL after TAVR is unknown. We examined consecutive patients with severe, symptomatic aortic stenosis who underwent TAVR with the Medtronic CoreValve followed by BPD with an InterValve V8 balloon for PVL grade ≥2+. Data from echocardiographic, multidetector computed tomographic, and angiographic images were reviewed. The primary endpoint was successful reduction in PVL to grade 1+ or less as assessed by intraprocedural echocardiography. Eleven patients were studied (median age, 82 years; 64% female). Ten patients (91%) demonstrated succ...

Research paper thumbnail of TCT-842 Embolic Particles Show Surprising Size Dependent Predilection for Cerebral versus Peripheral Arteries: Results from Computational Fluid Dynamic Modeling

Journal of the American College of Cardiology, 2012

Background: Transcatheter aortic valve implantation (TAVI) has been established as a reliable alt... more Background: Transcatheter aortic valve implantation (TAVI) has been established as a reliable alternative treatment in high risk patients, resulting in symptoms and left ventricle function improvement. The aim of this study was to evaluate the impact of TAVI on early recovery of left ventricle function using echocardiographic left ventricular deformation parameters and to define their possible correlation with myocardial function. Methods: 16 patients (6 females, 81 Ϯ 5 years; EuroScore: 24 Ϯ 4%) with severe aortic stenosis but free of significant coronary artery disease, who underwent TAVI with the CoreValve aortic prosthesis were studied. Conventional 2D and 2D-speckle echocardiography analysis were performed pre-interventional and at discharge. Deformation indices of left ventricle, such as Peak Systolic Longitudinal Strain (PSLS) and Torsion (apex-basal rotation) were determined by speckle tracking echocardiography using commercially available computer software. Besides, Left Ventricle Ejection Fraction (LVEF), calculated with Simpson method, was evaluated at one month follow-up. Results: In all patients at discharge, a reduction of transaortic peak pressure gradient (pϽ0.0005), of mean pressure gradient (pϽ0.0001) was observed, with a concomitant increase in aortic valve area (pϽ0.0001). In addition, 2D speckle analysis showed a significant improvement of PSLS at discharge (Ϫ10.6Ϯ2.8 vs Ϫ12.8Ϯ3.9%, pϭ0.008). Similarly, left ventricle Torsion was significantly increased comparing to pre-implantation values (7.2Ϯ5.1 vs 11.5Ϯ6, pϭ0.015). However, overall LVEF did not change (51.4Ϯ8.8 vs 50.9Ϯ8.1%; pϭ0.55). During follow-up, a strong correlation was found between discharge PSLS and one month LVEF, with greater longitudinal deformation (PSLS) associated with higher LVEF (pϭ0.03). However, one month LVEF compared to discharge, indicated a trend for improvement (pϾ0.05), but not statistically significant. Conclusions: Deformation indices of PSLS and Torsion are able to detect early improvement of left ventricle function after TAVI regardless LVEF alteration. Moreover, PSLS seems to predict LVEF in one month. Larger studies with long term follow-up are required.

Research paper thumbnail of Cardiogenic Shock: No Longer a Contraindication to Therapeutic Hypothermia in Survivors of Cardiac Arrest

Journal of the American College of Cardiology, 2012

Background: Therapeutic hypothermia (TH) is neuroprotective and increases survival in cardiac arr... more Background: Therapeutic hypothermia (TH) is neuroprotective and increases survival in cardiac arrest survivors. Cardiac arrest is often seen in the setting of ST-elevation myocardial infarction (STEMI), and cardiogenic shock (CS) is a known poor prognostic factor. Methods: From Feb 2006 to July 2011, 252 consecutive cardiac arrest patients who remained comatose following return of spontaneous circulation were enrolled in a TH protocol, integrated into a regional STEMI transfer network. Patients were treated regardless of past medical history, initial rhythm or hemodynamic status. The aim of this study was to determine if there were any predictors of CS in this population and their effect on morbidity and mortality. Results: Of the 252 patients, 92 (36.5%) were in CS. Survival with favorable neurologic outcome (CPC 1 or 2) was poorer in CS patients than no CS patients, 33/92 (35.9%) vs 83/160 (51.9%), p=0.014. Patients in CS were older 65.5 vs 61.5 years p=0.02 and had a higher incidence of preexisting cardiomyopathy (CM) 41/92 (44.6%) vs 41/160 (25.6%) p=0.002 and concurrent STEMI 43/92 (46.7%) vs 44/160 (27.5%) p=0.002. Ischemic CM was the most common type 34/41 (83.0%). The odds ratio of CS in patients with pre-existing CM was OR=2.33 (1.36, 4.02). The odds ratio of CS in patients with concurrent STEMI was OR=2.31 (1.35, 3.96). There was no statistical difference in gender, initial rhythm, transfer distance, history of CAD, HTN, or CHF between patients in CS versus those without CS. There was a trend of lower survival with CPC 1/2 in pre-existing CM patients than those without 12/41 (29.3%) vs 21/51 (41.2%) p=0.24. There was a trend of higher survival with CPC 1/2 in patients in CS and concurrent STEMI than CS alone 19/43 (44.2%) vs 14/49 (28.6%) p=0.12. Conclusion: Pre-existing CM and concurrent STEMI are associated with higher incidence of CS. Prior CM is common among those with CS. CS has an unexpectedly favorable outcome with TH. TH should be the standard of care for unresponsive cardiac arrest patients in CS.

Research paper thumbnail of Cardiac Chamber and Tricuspid Annulus Relations in Tricuspid Regurgitation Three-Dimensional Computed Tomographic Analysis

Journal of the American College of Cardiology, 2014

background: Tricuspid regurgitation (TR) is a potent determinant of long term prognosis in patien... more background: Tricuspid regurgitation (TR) is a potent determinant of long term prognosis in patients with valvular heart disease. Yet relationships among the tricuspid valve (TV) and cardiac chamber anatomy are incompletely characterized. As percutaneous TV repair/replacement is under development, precise definition of TV and associated chamber anatomy is assuming great importance. This study evaluated tricuspid and cardiac chambers using echocardiography and three-dimensional computed tomography (3DCT). methods: Echocardiography and 3DCT image data were analyzed in 633 patients. Patients were divided into 2 groups according to echocardiographic TR severity as no TR (Group 1, TR none or mild, n=573) and significant TR (Group 2, TR significant, moderate or severe, n=60). Tricuspid annulus area (TAA) and cardiac chamber dimensions were measured at ventricular mid-diastole. results: Differences between groups included age >75 years, presence of left valve disease (LVD) and atrial fibrillation (AF). Patients with significant TR differed by univariate analysis in normalized TAA (n-TAA) and in all cardiac chamber indices (right atrial volume index (RAi), left atrial volume index (LAi), right ventricle volume index (RVi) and left ventricle volume index (LVi)). Multivariate analysis found that n-TAA, RVi, age >75 years, female gender, LVD and AF were independent predictors of significant TR. Optimal threshold values differentiating patients with significant TR by receiver-operating characteristic analysis were: n-TAA (cut off value, area under the curve) 804 mm2/m2 (0.835), RAi 64 ml/m2 (0.814), RVi 73 ml/ m2 (0.717), LAi 61 ml/m2 (0.700) and LVi 71ml/m2 (0.602). conclusions: TR is associated with significant enlargement of all cardiac chambers. Threshold values for significant TR can be defined statically and may assist with determining need for TR intervention as percutaneous therapies become available.

Research paper thumbnail of Effectiveness of Transcatheter Reduction of Significant Mitral Regurgitation in High Surgical Risk Patients with Mitraclip: Final 5 Year Results of the Everest II High Risk Registry

Journal of the American College of Cardiology, 2014

Research paper thumbnail of Relationships Between Tricuspid Regurgitation, Elevated Pulmonary Pressure and Right Heart Remodeling

Journal of the American College of Cardiology, 2014

The study evaluated 455 patients with both echocardiography and 3-dimensional computed tomography... more The study evaluated 455 patients with both echocardiography and 3-dimensional computed tomography (CT). Cases were divided into 3 groups by TR severity: Group I, trace TR, n=217; Group 2, mild TR, n=174, and Group 3, moderate/severe TR n=64. Each TR group was subdivided into 2 subgroups (subgroup a: PH absent and subgroup b: PH present) by the presence or absence of PH, defined as PAP >40 mmHg. Six groups resulted. In each group measurements were made of the tricuspid annulus area and index (TAA), right atrium volume and index (RA) and right ventricular volume (RV) and index using CT images.

Research paper thumbnail of Contemporary Reasons for Medical Rather Than Surgical Therapy in Patients with Symptomatic Aortic Stenosis

Journal of the American College of Cardiology, 2014

background: There has been recent increase in the therapies available for treatment of symptomati... more background: There has been recent increase in the therapies available for treatment of symptomatic aortic stenosis (SAS). We examined the current reasons for lack of aortic valve replacement (AVR) in patients with severe SAS and indications for surgical therapy. methods: We identified 131 patients (mean age, 80.2 ± 9.8 years; 52.6% men; mean STS score, 9.7% ± 4.6%) seen at our institution in 2012 for severe SAS as determined via transthoracic echocardiography. Patient demographics, comorbidities, echocardiographic data, clinical events, and reasons for medical therapy rather than AVR were examined.

Research paper thumbnail of Paravalvular leak after transcatheter aortic valve implantation: trading one disease for another?

Expert Review of Cardiovascular Therapy, 2014

Research paper thumbnail of Exclusion of atrial thrombus by transesophageal echocardiography does not preclude embolism after cardioversion of atrial fibrillation. A multicenter study

Circulation, 1994

BACKGROUND Transesophageal echocardiography (TEE) has been used recently to detect atrial thrombi... more BACKGROUND Transesophageal echocardiography (TEE) has been used recently to detect atrial thrombi before cardioversion of atrial arrhythmias. It has been assumed that embolic events after cardioversion result from embolism of preexisting atrial thrombi that are accurately detected by TEE. This study examined the clinical and echocardiographic findings in patients with embolism after cardioversion of atrial fibrillation despite exclusion of atrial thrombi by TEE. METHODS AND RESULTS Clinical and echocardiographic data in 17 patients with embolic events after TEE-guided electrical (n = 16) or pharmacological (n = 1) cardioversion were analyzed. All 17 patients had nonvalvular atrial fibrillation, including four patients with lone atrial fibrillation. TEE before cardioversion showed left atrial spontaneous echo contrast in five patients and did not show atrial thrombus in any patient. Cardioversion resulted in return to sinus rhythm without immediate complication in all patients. Thirt...