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Background: Prescription opioids are a major cause of the opioid epidemic. Despite the invasive nature of cardiac implantable electronic device (CIED) procedures, data on opioid prescription patterns after CIED procedures are lacking.Objective: The purpose of this study was to assess opioid prescribing patterns and the rates of new opioid refills (refills in previously opioid naïve patients) among patients undergoing CIED procedures.Methods: We performed a retrospective analysis of all patients undergoing CIED procedures from January 1, 2010, to March 30, 2018, at the Mayo Clinic (Minnesota, Arizona, and Florida). Procedures were categorized into new implant, generator change, device upgrade, lead revision or replacement, and subcutaneous implantable cardiac defibrillator (S-ICD) procedures. The rates of postoperative opioid prescription and new opioid refills were analyzed. Wilcoxon rank sum and χ2 tests assessed variations.Results: A total of 16,517 patients (mean age 70 ± 15; 36% female) underwent CIED procedures. Opioids were prescribed to 20.2% of the patients, among whom 80% were opioid naïve. Among opioid naïve patients who received opioids, 9.4% (95% confidence interval [CI] 8.3%-10.5%) had subsequent opioid refills. The percentage of patients who received more than 200 oral morphine equivalents of prescription was 38.8% (95% CI 37.2%-40.5%). Temporal trends revealed increasing rates of any opioid prescription, peaking in 2015 at 25.9%, with subsequent downtrend to 14.6% in 2018 (P <.001).Conclusion: Postoperative opioid prescription rate after CIED procedures was 20.2%, with most patients being opioid naïve. Among opioid naïve patients who received opioids, 9.4% had subsequent opioid refills. This finding suggests that perioperative pain management in CIED procedures warrants meticulous attention. [ABSTRACT FROM AUTHOR]

The rapid development of transcatheter tricuspid valve intervention (TTVI) therapies has quickly provided the opportunity to improve patient selection and procedural planning for patients with significant tricuspid regurgitation (TR) considered at high surgical risk. This review focuses on the contributions which both computed tomography angiography and cardiac magnetic resonance can provide in the better understanding of the natural history of TR, in the comprehensive anatomical and functional assessment of right heart involvement and in the timing and planning for TTVI. We also discuss areas of potential importance such as the quantification of response to TTVI, which will be informative for future trials. [ABSTRACT FROM AUTHOR]

Transcatheter therapy with the MitraClip system (Abbott Structural, Menlo Park, CA) is the most commonly used transcatheter therapy for patients with tricuspid regurgitation, with over 1000 cases performed worldwide. The procedure is an off-label approach that requires meticulous attention to anatomical features obtained via comprehensive echocardiography and, in some cases, using cardiac computed tomography. Herein, we describe patient selection, procedural performance, and clinical outcomes of this therapy. [ABSTRACT FROM AUTHOR]

Mitral regurgitation is the most commonly occurring valvular heart disease in developed countries. Transcatheter mitral valve replacement (TMVR) has emerged as a novel potential therapy for patients with severe mitral valve disease who are unsuitable candidates for conventional surgery or transcatheter edge-to-edge mitral repair. TMVR with the Tendyne prosthesis has shown potential at short-term follow-up to be an effective and safe treatment alternative for high-risk patients with severe mitral valve disease. [ABSTRACT FROM AUTHOR]

Abstract Objectives The aim of this study was to gain insight into the causes and outcomes of patients who do not qualify for transcatheter mitral valve replacement (TMVR). Background Despite the increasing availability of TMVR, patients with severe mitral regurgitation may not be eligible. Thus far, no investigation has examined ineligible patients and their clinical outcomes. Methods A total of 203 patients (mean age 79 ± 9 years, 48% men) who were ineligible for participation in early feasibility studies of TMVR were examined. Results The ineligibility rate for TMVR was 89.0%. The most common reasons for TMVR exclusion were excessive frailty (15.3%), severe tricuspid regurgitation (15.3%), and prior aortic valve therapy (14.2%). Mitral anatomic exclusions were present in 15.8%, with severe annular calcification in 7.4%, and risk for left ventricular outflow tract obstruction was notably infrequent (4.4%). Overall, 76 patients (37.4%) did not undergo subsequent commercial surgical or transcatheter mitral therapy. Patients not eligible for TMVR and not treated commercially had high rates of cardiac death (11.8%) and death or heart failure hospitalization (22.4%) at 1 year. These rates were significantly higher than those who underwent surgery (2.4% for cardiac death; p < 0.001; 5.5% for heart failure hospitalization; p = 0.003) and remained worse after excluding patients with excessive frailty or medical futility and in multivariate modeling that adjusted for baseline differences. Conclusions Patients ineligible for TMVR and treated medically have poor outcomes. These data and the high rate of TMVR screen failure support the need for therapy iteration as well as development of alternative means of management, with the goal of improving the prognosis of these patients. Graphical abstract [ABSTRACT FROM AUTHOR]

Background: Although large randomized clinical trials have found that primary prevention use of an implantable cardioverter-defibrillator (ICD) improves survival in patients with cardiomyopathy and heart failure symptoms, patients who receive ICDs in practice are often older and have more comorbidities than patients who were enrolled in the clinical trials. In addition, there is a debate among clinicians on the usefulness of electrophysiological study for risk stratification of asymptomatic patients with Brugada syndrome.Aim: Our analysis has 2 objectives. First, to evaluate whether ventricular arrhythmias (VAs) induced with programmed electrostimulation in asymptomatic patients with Brugada syndrome identify a higher risk group that may require additional testing or therapies. Second, to evaluate whether implantation of an ICD is associated with a clinical benefit in older patients and patients with comorbidities who would otherwise benefit on the basis of left ventricular ejection fraction and heart failure symptoms.Methods: Traditional statistical approaches were used to address 1) whether programmed ventricular stimulation identifies a higher-risk group in asymptomatic patients with Brugada syndrome and 2) whether ICD implantation for primary prevention is associated with improved outcomes in older patients (>75 years of age) and patients with significant comorbidities who would otherwise meet criteria for ICD implantation on the basis of symptoms or left ventricular function.Results: Evidence from 6 studies of 1138 asymptomatic patients were identified. Brugada syndrome with inducible VA on electrophysiological study was identified in 390 (34.3%) patients. To minimize patient overlap, the primary analysis used 5 of the 6 studies and found an odds ratio of 2.3 (95% CI: 0.63-8.66; p=0.2) for major arrhythmic events (sustained VAs, sudden cardiac death, or appropriate ICD therapy) in asymptomatic patients with Brugada syndrome and inducible VA on electrophysiological study versus those without inducible VA. Ten studies were reviewed that evaluated ICD use in older patients and 4 studies that evaluated unique patient populations were identified. In our analysis, ICD implantation was associated with improved survival (overall hazard ratio: 0.75; 95% confidence interval: 0.67-0.83; p<0.001). Ten studies were identified that evaluated ICD use in patients with various comorbidities including renal disease, chronic obstructive pulmonary disease, atrial fibrillation, heart disease, and others. A random effects model demonstrated that ICD use was associated with reduced all-cause mortality (overall hazard ratio: 0.72; 95% confidence interval: 0.65-0.79; p<0.0001), and a second "minimal overlap" analysis also found that ICD use was associated with reduced all-cause mortality (overall hazard ratio: 0.71; 95% confidence interval: 0.61-0.82; p<0.0001). In 5 studies that included data on renal dysfunction, ICD implantation was associated with reduced all-cause mortality (overall hazard ratio: 0.71; 95% confidence interval: 0.60-0.85; p<0.001). [ABSTRACT FROM AUTHOR]

Obtaining femoral and radial arterial access in the cardiac catheterization laboratory using state-of-the-art techniques is essential to optimize outcomes, patient satisfaction, and procedural efficiency. Although transradial access is increasingly used for coronary angiography and percutaneous coronary intervention, femoral access remains necessary for numerous procedures, many requiring large-bore access, including complex high-risk coronary interventions, structural procedures, and procedures involving mechanical circulatory support. For femoral access, contemporary access techniques should combine the use of fluoroscopy, ultrasound, micropuncture needle, femoral angiography, and vascular closure devices, when feasible. For radial access, ultrasound may reveal important anatomic features and expedite access. Despite randomized controlled trials supporting use of routine ultrasound guidance for femoral and/or radial arterial access, ultrasound remains underused in cardiac catheterization laboratories. This article reviews contemporary techniques to achieve optimal arterial access in the cardiac catheterization laboratory. [ABSTRACT FROM AUTHOR]

Severe mitral regurgitation (MR) confers an adverse prognosis, frequently with debilitating symptoms of heart failure. While open surgical correction has been the standard of care for decades, novel catheter-based technologies have emerged that are highly effective in the treatment of MR. These percutaneous technologies, which include methods for both repair as well as valve replacement, have the potential to address unmet clinical needs in patients with MR, and serve as a viable alternative to surgery. [ABSTRACT FROM AUTHOR]

Objectives The authors sought to compare the outcomes of commercial transcatheter aortic valve replacement (TAVR) with the repositionable Evolut R platform to those observed with the CoreValve device in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry. Background TAVR continues to evolve, with rapid adoption of iterative changes for commercial practice. Insight into the outcomes of this adoption is needed. Methods Patients in the TVT Registry who had TAVR using a 23-, 26-, or 29-mm self-expanding prosthesis were enrolled. Site-reported events for procedural, in-hospital, and 30-day outcomes were examined. Results Between January 2014 and April 2016, 9,616 patients underwent TAVR with a self-expanding prosthesis with data entered in the TVT Registry. Compared with patients treated with CoreValve TAVR, those who received Evolut R TAVR had a lower STS-PROM score (8.0 ± 5.4% vs. 8.7 ± 5.3%; p < 0.001), more iliofemoral access (91.6% vs. 89.2%; p < 0.001), and more frequently had conscious sedation (27.4% vs. 12.7%; p < 0.001). With Evolut R TAVR, there was less need for a second prosthesis (2.2% vs. 4.5%; p < 0.001), less device migration (0.2% vs. 0.6%; p = 0.01), a lower incidence of moderate/severe paravalvular regurgitation (post-procedure, 4.4% vs. 6.2%; p < 0.001), and shorter median hospital stay (4.0 vs. 5.0 days; p < 0.001). Patients treated with Evolut R TAVR had greater device success (96.3% vs. 94.9%; p = 0.001). At 30 days, Evolut R patients had both lower mortality (3.7% vs. 5.3%; p < 0.001) and less need for a pacemaker (18.3% vs. 20.1%; p = 0.03). Conclusions Commercial adoption of the Evolut R platform is associated with significant improvements in acute outcomes for patients undergoing TAVR for aortic stenosis. [ABSTRACT FROM AUTHOR]

Introduction To facilitate coaxial device deployment in transcatheter mitral valve replacement (TMVR), a coaxial approach to the mitral annular plane is needed. We sought to establish a method to determine an ‘orthogonal’ left ventricular (LV) access point for transapical TMVR and to quantitatively characterize its location in patients with severe mitral regurgitation using cardiac computed tomography. Methods Cardiac CT data sets of 54 patients with moderate-severe mitral regurgitation evaluated for potential TMVR were analyzed. The D-shaped mitral annular contour was segmented and a 2-dimensional annular plane was derived, allowing for subsequent definition of the perpendicularly oriented mitral annular trajectory. The ‘orthogonal’ LV access point was defined as the transection point of mitral trajectory with the LV epicardial surface. The location of the access point was quantified by its epicardial distance from the true apex and by the rotational offset from a 3-chamber view. Results LV access points orthogonal to the mitral annular plane were most frequently located in the anterolateral (n = 22, 40.7%) and anterior (n = 16, 29.6%), less frequently anteroseptal (n = 6, 11.1%) and inferolateral (n = 5, 9.3%) ventricular segment; none inferior or inferoseptal. The mean distance to the LV apex was 17.6 ± 7.7 mm. The mean forward rotational offset from the 3-chamber view was 96.4 ± 43.4°, relating to a mean forward rotational offset of 6.4 ± 43.4° in regard to a hypothetical, secondary 90° x-plane view. No significant difference between patients with degenerative mitral valve disease or functional mitral regurgitation was observed. Conclusion The location of the LV access point that provides an orthogonal trajectory to the mitral annular plane exhibits relevant inter-individual variability. It is commonly not identical with the true apex, and frequently localized in the anterolateral or anterior ventricular segments. [ABSTRACT FROM AUTHOR]

Corresponding Author [ABSTRACT FROM AUTHOR]

Objective Severe, late functional tricuspid regurgitation is characterized by annulus dilation, right ventricular enlargement, and papillary muscle displacement with leaflet tethering. However, the early stages of mild tricuspid regurgitation and its progression are poorly understood. This study examined structural heart changes in mild, early tricuspid regurgitation. Methods Sequential patients undergoing cardiac computed tomography and transthoracic echocardiography with tricuspid regurgitation were identified and evaluated. The tricuspid annulus area and chamber volumes were measured by computed tomography angiography and categorized by tricuspid regurgitation severity. Results Patients (n = 622) were divided into 3 groups by tricuspid regurgitation severity: no/trace (n = 386), mild (n = 178), and moderate/severe tricuspid regurgitation (n = 58). Annulus area was highly dependent on and proportional to regurgitation severity and correlated with both right/left atrial enlargement. Annulus area most strongly correlated with right and left atrial volume, and the annulus shape changed from elliptical to circular in moderate/severe tricuspid regurgitation. Mild tricuspid regurgitation was associated with less right/left atrial enlargement than significant tricuspid regurgitation, normal right ventricular size, and annular dilation. Significant tricuspid regurgitation was associated with annular dilation, circularization, and right ventricular enlargement. Mild and significant tricuspid regurgitation were differentiated by annulus area and indexed right ventricular volume. Conclusions Tricuspid annular dilation and right/left atrial enlargement comprise early events in mild functional tricuspid regurgitation. Atrial enlargement occurs before right ventricular dilation, which occurs late, when tricuspid regurgitation is severe. Atrial volume and tricuspid annular dilation are early and sensitive indicators of tricuspid regurgitation significance. [ABSTRACT FROM AUTHOR]

Percutaneous repair of aortic paravalvular regurgitation can help avoid the need for repeat valve surgery. Although the initial diagnosis of paravalvular regurgitation is usually made with echocardiography, cardiac CT angiography helps to determine the site and morphology of these leaks. The utility of CT is highly dependent on the quality of the data. Herein, we describe a systematic approach to image acquisition and interpretation of cardiac CT angiography in patients with aortic paravalvular regurgitation, which integrates findings from echocardiography. This approach can be used to minimize inaccuracies in the diagnosis and enhance the procedural success for percutaneous repair of aortic paravalvular regurgitation. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to assess the learning curve for percutaneous repair of paravalvular prosthetic regurgitation. Background: Percutaneous repair of prosthetic paravalvular regurgitation is a complex procedure. There is a paucity of data on the professional experience and tools needed to achieve optimal clinical outcomes. Methods: We examined the chronological experience of 200 patients (age 66 ± 13 years; 57% men) who underwent percutaneous closure of paravalvular prosthetic regurgitation at our institution. A sequence number of the patient was assigned as a continuous variable for analysis. Results: A total of 243 paravalvular defects (74% mitral; 26% aortic) were treated. Device delivery was successful in 92% with an average procedural time of 139 ± 47 min. The 30-day rate of major adverse cardiovascular events was 7%. With increased case experience and adoption of dedicated imaging and catheter techniques, there were decreases in procedural time, fluoroscopy time, contrast volume administered, length of hospital stay, and major adverse cardiovascular events. Procedural success remained unchanged throughout the experience. The predominant reason for procedural failure was prosthetic leaflet impingement, which accounted for 9 of 21 failed cases. Conclusions: In this single-center experience, there was evidence of a learning curve that occurred with the adoption of dedicated techniques for catheter delivery and echocardiographic imaging. In experienced operators, the potential for prosthetic leaflet impingement is the predominant limitation of the procedure. These data have implications for physician training and performance in complex structural heart disease interventions. [Copyright &y& Elsevier]

Background. Myocardial bridging describes systolic compression of the muscular investment of a portion of an epicardial coronary artery. We evaluated the outcome of muscular bridge unroofing of the left anterior descending artery at the time of septal myectomy in patients with hypertrophic cardiomyopathy. Methods. We conducted a case-controlled study of 36 patients (23 men; median age, 42 years) with hypertrophic cardiomyopathy and myocardial bridging. Group 1 patients had septal myectomy and concomitant unroofing (n = 13), group 2 patients underwent myectomy alone (n = 10), and group 3 patients were treated medically (n = 13). Results. Angina was more prevalent preoperatively in group 1, 46% compared with 20% in group 2. Preoperative left ventricular outflow tract gradients of 67.8 ± 58.2 mm Hg and 74.1 ± 19.7 mm Hg were reduced to 1.9 ± 2.9 mm Hg in group I (p < 0.0001) and to 5.6 ± 8.8 mm Hg in group 2 (p < 0.0001). In the surgical groups, there were no early deaths or complications related to unroofing. Survival at 10 years was 83.3% in group I (p = 0.297), 100.0% in group 2, and 67.9% in group 3; there were no late sudden deaths. At follow-up, 77% in group 1 were asymptomatic compared with 70% of patients in group 2 (p = 0.19). There was no recurrent angina in group 1. Conclusions. Myocardial unroofing can be performed safely at the time of septal myectomy for left ventricular outflow tract obstruction. Angina was improved, but we found no difference in late survival compared with patients who had myocardial bridging and myectomy alone. Unroofing should be considered in patients with angina who have significant left anterior descending artery bridging and require myectomy. [ABSTRACT FROM AUTHOR]

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Background: Midventricular obstruction in hypertrophic cardiomyopathy (HCM) is less common than subaortic obstruction, and there are few data on outcomes after surgical treatment. Methods: We reviewed 56 consecutive patients (28 men) with HCM and midventricular obstruction who underwent myectomy between February 1997 and June 2012. Five patients had prior myectomy for subaortic obstruction. Mean age was 42 ± 17 years. Preoperatively, 51% of patients had dyspnea, and the remaining had palpitations (25%), angina (5%), or syncope (9%). Results: Midventricular obstruction was relieved by means of a transaortic myectomy in 5 patients, a transapical approach in 32 patients, and combined transaortic and transapical incisions in 19 patients. In 13 patients, an apical aneurysm or pouch was repaired at the time of midventricular myectomy. There were no early deaths. Intraoperative intraventricular gradients were reduced from 64 ± 32 mm Hg before myectomy to 6 ± 12 mm Hg postoperatively (p ≤ 0.0001). Early complications included atrial arrhythmias in 5 patients and reoperation for bleeding in 4 patients. Fifty patients had follow-up beyond 30 days (median, 1.6 years; range, 33 days to 13 years). Survival at 1 and 5 years was 100% and 95%, and average New York Heart Association class improved from 2.9 ± 0.7 preoperatively to 1.3 ± 0.6 postoperatively (p = 0.0001). There were no aneurysms related to the apical incision; 2 patients had late reoperation, 1 for resection of right atrial mass to prevent embolus. Conclusions: A transapical approach allows excellent exposure for midventricular myectomy and relief of intraventricular gradients and related symptoms. There were no complications unique to the apical incision, and 5-year survival was similar to expected survival (95% versus 97%). [Copyright &y& Elsevier]

Objectives: The purpose of this study was to report the results of percutaneous valve-in-valve therapy using the Melody valve (Medtronic, Minneapolis, Minnesota) for patients with degenerated mitral and tricuspid bioprosthetic valves. Background: Open surgery for replacement of degenerated bioprosthetic valves is associated with morbidity and mortality. Methods: Nineteen patients (median age 65 years, range 10 to 88 years; 7 males) with degenerated mitral (n = 9) or tricuspid (n = 10) bioprosthetic valves underwent transvenous valve-in-valve implantation of the Melody valve. Results: In the mitral patients, the mean Society of Thoracic Surgeons mortality score was 13.3 ± 5.6%. All patients had a prosthetic valve mean diastolic inflow gradient ≥5 mm Hg. Moderate or worse regurgitation was present in 7 of 9 mitral and 7 of 10 tricuspid patients. Implantation of a Melody valve was successful in all. Among the mitral patients, mean diastolic gradient decreased from 12.3 ± 4.6 mm Hg to 5.2 ± 2 mm Hg (p < 0.01). Residual regurgitation was trivial to mild in 6, mild to moderate in 2, and moderate in 1 patient. Among the tricuspid patients, mean diastolic gradient decreased from 10.0 ± 4.3 mm Hg to 5.6 ± 2.5 mm Hg (p < 0.01). Residual regurgitation was trivial to mild in 9 and mild to moderate in 1 patient. New York Heart Association functional class improved in 17 of 19 patients (p < 0.01). No periprocedural deaths, myocardial infarctions, strokes, or valve embolizations occurred. Vascular access site complications occurred in 4 patients. Conclusions: Percutaneous valve-in-valve implantation of the Melody valve in the mitral or tricuspid position for treatment of bioprosthetic valve dysfunction is feasible and can lead to significant symptomatic improvement in carefully selected high-risk patients. [Copyright &y& Elsevier]

Objectives: This study examined the relationship between peak-to-peak (common invasive measurement), peak instantaneous (common Doppler measurement), and mean pressure gradients in patients with hypertrophic cardiomyopathy (HCM) and aortic stenosis (AS). Background: In patients with AS, the peak-to-peak gradient and peak instantaneous gradient are discrepant, and the mean gradient best represents obstruction severity. The pathophysiology of outflow obstruction differs in HCM, with the maximum gradient occurring in late systole, thus the optimal method for quantifying gradient severity in HCM remains undefined. Methods: Fifty patients with HCM and 50 patients with AS underwent gradient characterization at cardiac catheterization (age 55 ± 15 years vs. 72 ± 9 years; 48% vs. 42% male, respectively). All HCM patients were studied with high-fidelity, micromanometer-tip catheters and transseptal measurement of left ventricular inflow and central aortic pressures. In AS, simultaneous left ventricular and central aortic pressures were recorded. Results: The peak instantaneous gradient was linearly correlated with peak-to-peak gradient in HCM (R2 = 0.98, p < 0.0001), with the relationship close to the line of identity. In AS, more scatter and further deviation from the line of identity occurred when comparing the peak instantaneous gradient to the peak-to-peak gradient (R2 = 0.70, p < 0.0001). Both peak-to-peak and peak instantaneous gradients were consistently higher than the mean gradient in HCM, with wide 95% confidence limits of agreement (26.7 ± 46.5 mm Hg and 16.4 ± 47.2 mm Hg, respectively). Conclusions: In HCM, peak instantaneous and peak-to-peak gradient demonstrate excellent correlation. Consequently, both peak instantaneous and peak-to-peak gradients can be used to classify obstruction severity in HCM. By contrast, the mean gradient should direct clinical management in AS. [ABSTRACT FROM AUTHOR]

Abstract: INTRODUCTION: Erdheim–Chester disease is a rare, non-Langerhans histiocytosis in which pericardial involvement is diagnosed with increasing frequency and is associated with high mortality rates. PRESENTATION OF CASE: A 53-year-old woman presented with progressive exertional dyspnea and pericardial effusion was discovered. Further investigations revealed the presence of a diffuse, infiltrating process and a diagnosis of Erdheim–Chester disease was made. An emergent pericardiocentesis by subxiphoid approach was completed but recurrent drainage obviated removal of the pigtail catheter. A pleuro-pericardial window was placed using video-assisted thoracoscopic surgery (VATS) and analysis of the resected specimen confirmed pericardial involvement. DISCUSSION: In this case, high pericardial fluid output demanded definitive treatment of the pericardial effusion. Traditionally this would be completed via thoracotomy. VATS is a minimally invasive alternative which permits exploration of the thoracic cavity and the creation of a pleuropericardial window. CONCLUSION: We describe, for the first time, the successful use of VATS for both diagnostic confirmation and therapeutic relief of recurrent pericardial fluid drainage due to pericardial involvement by Erdheim–Chester disease. [Copyright &y& Elsevier]

Paravalvular regurgitation affects 5% to 17% of all surgically implanted prosthetic heart valves. Patients who have paravalvular regurgitation can be asymptomatic or present with hemolysis or heart failure, or both. Reoperation is associated with increased morbidity and is not always successful because of underlying tissue friability, inflammation, or calcification. Comprehensive echocardiographic imaging with transthoracic and real-time 3-dimensional transesophageal echocardiography is key for characterizing the defect location, size, and shape. For paramitral defects, an antegrade transseptal approach can usually be guided by biplane fluoroscopy, and real-time 3-dimensional transesophageal echocardiography can usually be performed successfully. Alternative approaches to paramitral defects include retrograde transaortic cannulation or transapical access and retrograde cannulation. For oblong or crescentic defects, the simultaneous or sequential deployment of 2 smaller devices, as opposed to 1 large device, results in a higher degree of procedural success and safety because the risk of impingement on the prosthetic leaflets is minimized. Most para-aortic defects can be approached in a retrograde manner and closed with a single device. With careful anatomical assessment, procedural planning, and procedural execution, successful closure rates of 90% or more should be attainable with a low risk of device impingement on the prosthetic valve or embolization. [Copyright &y& Elsevier]

Objective: Many patients with symptomatic hypertrophic cardiomyopathy have minimal left ventricular outflow tract gradients, and there is uncertainty whether their limitation is due to diastolic dysfunction or labile outflow tract obstruction. The purpose of this study was to characterize the clinical presentation and outcome of septal myectomy in patients with hypertrophic cardiomyopathy and latent obstruction. Methods: Among 749 patients who underwent septal myectomy, 249 had latent obstruction with minimal (0–30 mm Hg) resting gradients preoperatively. All were symptomatic and had more severe left ventricular outflow tract obstruction provoked by Valsalva maneuver or amyl nitrite inhalation during Doppler echocardiography or by stimulation with isoproterenol during catheterization. Clinical characteristics, survival, and functional outcome of these patients were compared with those of 500 patients with more severe resting left ventricular outflow tract obstruction who underwent myectomy during the same period. Results: Compared with those with severe obstruction, more patients with latent obstruction were male (63% vs 52%, P < .003), but ages were similar (53 ± 14 years vs 52 ± 15 years). Preoperative symptoms and functional limitation were similar in the 2 groups with 86% and 85%, respectively, having New York Heart Association class III or IV disability. Among patients with latent obstruction, mixed venous oxygen saturation was 61.6% ± 19.0% of predicted compared with 56.8% ± 17.3% for those with severe resting obstruction (P < .008). Septal thickness was less in patients with latent obstruction (20 ± 9 mm vs 22 ± 15 mm, P < .001). Early mortality was 1% in each group, and survival at 5 and 10 years was 93% and 87%, respectively, for patients with latent obstruction compared with 93% and 74%, respectively, for patients with severe resting obstruction preoperatively (P = .34). Self-reported late functional status was similar; 3 to 5 years postoperatively, 81% of patients with latent obstruction preoperatively were in New York Heart Association class I or II compared with 77% of patients with severe resting obstruction. Conclusions: Patients with obstructive hypertrophic cardiomyopathy who have low resting gradients and latent obstruction may have limiting symptoms comparable to those of patients with more severe resting gradients. Septal myectomy should be offered to these patients because survival and symptom relief are excellent, suggesting that dynamic obstruction is the major hemodynamic problem rather than diastolic dysfunction. [ABSTRACT FROM AUTHOR]

Objectives: This study characterizes left ventricular outflow tract (LVOT) gradient variability in patients with hypertrophic cardiomyopathy (HCM) during cardiac catheterization. Background: Management of HCM is directed by the presence and magnitude of LVOT obstruction. The magnitude and clinical impact of spontaneous variability during a single cardiac catheterization has not been described. Methods: Fifty symptomatic patients with HCM (mean age 55 ± 15 years; 48% men) underwent cardiac catheterization with high-fidelity, micromanometer-tip catheters and transseptal measurement of left ventricular pressures. Obstruction was defined as resting LVOT gradient ≥30 mm Hg and severe obstruction as ≥50 mm Hg. Variability in LVOT gradient was calculated as the difference of the largest and smallest LVOT gradients in the absence of provocative maneuvers or interventions. Results: The largest LVOT gradient was 54.6 ± 56.4 mm Hg. The spontaneous variability in LVOT gradient was 49.0 ± 53.1 mm Hg (range 0 to 210.8 mm Hg, median 15 mm Hg). Discrepant classification of resting LVOT gradient severity was possible in 25 patients (50%). Twenty patients (40%) with severe obstruction could have been misclassified with regard to obstruction severity. Conclusions: In patients with HCM, the LVOT gradient fluctuates significantly during a single hemodynamic assessment. Spontaneous variability could lead to misclassification of obstruction severity in one-half of studied patients. The dynamic nature of LVOT obstruction must be considered when assessing resting hemodynamics or the success of a given intervention during cardiac catheterization. [ABSTRACT FROM AUTHOR]

Objective: Apical hypertrophic cardiomyopathy is a morphologic variant in which the hypertrophy is primarily localized to the apex of the left ventricle. A subset of patients have progressive, drug-refractory diastolic heart failure with severely limiting symptoms caused by low cardiac output. Heart transplantation has been the only therapeutic option available for such patients. This study analyzes clinical and hemodynamic outcomes of a novel surgical technique to improve diastolic filling by means of left ventricular cavity enlargement. Methods: Forty-four symptomatic patients underwent apical myectomy to augment left ventricular end-diastolic volume. Myectomy was performed through an apical incision, and hypertrophic muscle was excised at the apex and midventricle. Information from a prospective database was supplemented by surveys, patient contact, and medical records. Results: The mean age of the patients was 50 ± 17 years, and 66% were women. All patients were severely limited with dyspnea, 61% had angina, and 59% had syncope/presyncope. Ninety-one percent of patients were in New York Heart Association class III or IV. A mean of 16 ± 7 g of muscle was removed. Preoperative and postoperative hemodynamic catheterization (n = 14) showed a decrease in left ventricular end-diastolic pressure from 28 ± 9 to 24 ± 7 mm Hg (P = .002) and an increase in end-diastolic volume index from 55 ± 17 to 68 ± 18 mL/m2 (P = .003). Invasive measurements of stroke volume increased from 56 ± 17 to 63 ± 19 mL (P = .007). Of the 42 patients who survived to hospital discharge, 41 had improvement in symptoms. Mean peak maximum oxygen consumption with exercise (n = 5) increased from 13.5 ± 4.4 to 15.8 ± 4.6 mL/kg per minute. Survival at 1, 3, and 5 years was 95%, 81%, and 81%, respectively. At follow-up of 2.6 ± 3.1 years, 23 (74%) patients were in New York Heart Association class I or II. One patient underwent heart transplantation 5 years after apical myectomy. Conclusions: Apical myectomy improves functional status by decreasing left ventricular end-diastolic pressure, improving operative compliance, and increasing stroke volume. This procedure might be of value in other patients with hypertrophic cardiomyopathy who have severe hypertrophy and small left ventricular end-diastolic volume. [Copyright &y& Elsevier]

Objectives: This investigation sought to determine the feasibility of a novel method of a percutaneous mitral valve repair. Background: Percutaneous mitral valve repair has emerged as an alternative therapy for patients with functional mitral regurgitation. However, current methods that rely on cannulation of the coronary sinus may not result in direct reduction of the mitral annulus area due to the superior relationship of the sinus to the annulus. Methods: A novel device, consisting of helical stainless steel screws connected by a biocompatible tether, was designed for percutaneous mitral valve repair. This device was implanted by implanting the helical screws directly into the myocardium at the posteromedial mitral annulus of 8 anesthetized pigs from the right internal jugular vein. Results: Implantation of the device resulted in a 19.7 ± 0.1% reduction in mitral annular area and an 18.8 ± 0.1% decrease in the mitral anterior-posterior dimension (both p < 0.05 vs. baseline). This annular reduction persisted at 3-month follow-up. Both the coronary sinus and left circumflex coronary artery remained patent in all animals. There was no evidence of device migration, poor wound healing, or tissue thrombosis at the sites of device implantation. Conclusions: Percutaneous mitral valve repair targeting the ventricular myocardium from central venous access is feasible. By directly acting on the posteromedial mitral annulus, this methodology targets the mitral annular area most frequently affected by ischemic mitral regurgitation, lessens the risk of coronary artery impingement, promotes coronary sinus patency, and overcomes technical concerns that may arise when the coronary sinus lies significantly superior to the mitral annulus. [Copyright &y& Elsevier]

Objectives: The objective of this study was to examine the effects of septal ablation on diastolic function with the use of invasive hemodynamics. Background: Septal ablation is an alternative therapy for patients with obstructive hypertrophic cardiomyopathy (HCM). However, its beneficial effect on diastolic function, by relieving the systolic contraction load, may be countered by adverse effects from the infarction on left ventricular mechanics. Methods: Using high-fidelity, micromanometer-tipped catheters, we examined 40 HCM patients by taking direct measurements of the left ventricular outflow tract (LVOT) gradient, time constant of myocardial relaxation (tau), and left atrial pressure (LAP) before and after septal ablation. Results: Although there was an overall reduction in LVOT gradient, septal ablation resulted in variable changes in myocardial relaxation and left atrial pressure. In 20 patients (50%), LAP increased. The magnitude of LVOT gradient reduction directly correlated with the effects of septal ablation on LAP (R = 0.58; p < 0.0001). Those patients with a greater decrease in the LVOT gradient had better improvement in direct LAP. Furthermore, those patients with a larger decrease in left ventricular outflow tract gradient had a beneficial enhancement of ventricular relaxation, as measured by tau (R = 0.43; p = 0.006). Thus, the beneficial enhancement of relaxation was directly related to improvement in LAP (R = 0.75; p < 0.0001). Conclusions: Septal ablation results in variable effects on left ventricular filling pressure, which are dependent upon the magnitude of reduction in the LVOT gradient. These effects are mediated in part by effects of ablation on myocardial relaxation. These findings shed insight into the pathophysiologic effects of septal reduction therapy in patients with HCM. [Copyright &y& Elsevier]