NHLBI-Sponsored Randomized Trial of Postconditioning During Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction.

RATIONALE: Postconditioning at the time of primary percutaneous coronary intervention (PCI) for ST-segment-elevation myocardial infarction may reduce infarct size and improve myocardial salvage. However, clinical trials have shown inconsistent benefit. OBJECTIVE: We performed the first National Heart, Lung, and Blood Institute-sponsored trial of postconditioning in the United States using strict enrollment criteria to optimize the early benefits of postconditioning and assess its long-term effects on left ventricular (LV) function. METHODS AND RESULTS: We randomized 122 ST-segment-elevation myocardial infarction patients to postconditioning (4, 30 seconds PTCA [percutaneous transluminal coronary angioplasty] inflations/deflations)+PCI (n=65) versus routine PCI (n=57). All subjects had an occluded major epicardial artery (thrombolysis in myocardial infarction=0) with ischemic times between 1 and 6 hours with no evidence of preinfarction angina or collateral blood flow. Cardiac magnetic resonance imaging measured at 2 days post-PCI showed no difference between the postconditioning group and control in regards to infarct size (22.5±14.5 versus 24.0±18.5 g), myocardial salvage index (30.3±15.6% versus 31.5±23.6%), or mean LV ejection fraction. Magnetic resonance imaging at 12 months showed a significant recovery of LV ejection fraction in both groups (61.0±11.4% and 61.4±9.1%; P<0.01). Subjects randomized to postconditioning experienced more favorable remodeling over 1 year (LV end-diastolic volume =157±34 to 150±38 mL) compared with the control group (157±40 to 165±45 mL; P<0.03) and reduced microvascular obstruction ( P=0.05) on baseline magnetic resonance imaging and significantly less adverse LV remodeling compared with control subjects with microvascular obstruction ( P<0.05). No significant adverse events were associated with the postconditioning protocol and all patients but one (hemorrhagic stroke) survived through 1 year of follow-up. CONCLUSIONS: We found no early benefit of postconditioning on infarct size, myocardial salvage index, and LV function compared with routine PCI. However, postconditioning was associated with improved LV remodeling at 1 year of follow-up, especially in subjects with microvascular obstruction. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01324453.

Reshaping bicuspid aortic valve stenosis with an hourglass-shaped balloon for transcatheter aortic valve replacement: A pilot study.

OBJECTIVES: We evaluated the safety and usefulness of preparatory anatomical reshaping with a geometric hourglass-shaped balloon to optimize transcatheter aortic valve replacement (TAVR) outcomes in bicuspid aortic valve (BAV) stenosis. BACKGROUND: TAVR has been increasingly performed for BAV stenosis; however, technical challenges remain. Procedural results are suboptimal given unfavorable valvular anatomies. METHODS: Eligible patients with BAV stenosis were enrolled to undergo aortic valve predilatation with the hourglass-shaped TAV8 balloon before TAVR using the self-expandable Venus A-Valve. Procedural details and outcomes were compared to a sequential group of patients with BAV who underwent TAVR with the same device following preparatory dilatation using a cylindrical balloon. RESULTS: A total of 22 patients were enrolled in the TAV8 group and 53 were included in the control group. Valve downsizing was less common in the TAV8 group (36.4 vs. 67.9%; p = .012). Stable valve release and optimal implant depth were consistently achieved in the TAV8 group with no requirement for a second valve (0 vs. 17.0%; p = .039) and with higher device success rates (100.0 vs 77.4%; p = .014). Residual aortic regurgitation graded as ≥mild was less common in the TAV8 group (13.6 vs 45.3%; p = .009). Mortality was similar (0 vs. 3.8%; p = 1); no major/disabling stroke or conversion to open-heart surgery was seen in either group within 30 days. CONCLUSIONS: Compared with standard cylindrical balloon valvuloplasty, preparatory reshaping with the hourglass-shaped balloon before self-expandable TAVR in BAV was associated with significantly better procedural results and may encourage more promising outcomes.

Maneuvers for technical success with transcatheter mitral valve repair.

Mitral valve regurgitation (MR) is common, with a prevalence that exceeds 9% for those patients >75 years of age. For symptomatic patients with prohibitive surgical risk, transcatheter mitral valve repair with the MitraClip® system (Abbott Vascular, Menlo Park, CA) is available for clinical use and is effective in reducing MR in select patients. For optimal clinical success, the procedure requires mastery of complex catheterization skills with application of an in-depth understanding of the mitral valve anatomy. We herein describe elementary and advanced maneuvers for successful transcatheter mitral valve repair with MitraClip® . © 2017 Wiley Periodicals, Inc.

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

OBJECTIVES: 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. BACKGROUND: 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. METHODS: 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. RESULTS: Eleven patients were studied (median age, 82 years; 64% female). Ten patients (91%) demonstrated successful reduction in PVL after V8 BPD. In three patients, PVL was reduced to zero or trace. PVL remained unchanged in one patient (2+). Two patients had complete heart block associated with valve deployment and received permanent pacemakers. There were no occurrences of annular injury or major adverse clinical events. CONCLUSIONS: BPD with the V8 hourglass-shaped balloon was feasible in reducing PVL from self-expanding TAVR prostheses. © 2016 Wiley Periodicals, Inc.

Patho-Histological Findings of Annular Rupture Related to Left Ventricular Outflow Tract (LVOT) Calcification Following Transcatheter Aortic Valve Replacement (TAVR).

Peri-aortic hematoma has been recently described as a potentially life-threatening complication following transcatheter aortic valve replacement (TAVR). Patient- and procedure-related factors exist that predispose to peri-aortic hematoma formation, which can progress to myocardial rupture at the aortic root-myocardial junction. While conservative therapy with blood pressure control is the expectant management following peri-aortic hematoma formation, myocardial rupture can occur at the site of the aortic annulus. Hence, interventionists and echocardiologists must be prepared for emergent intervention to salvage the patient once the complication is recognized. The present report highlights the patho-histological findings related to left ventricular outflow tract calcification following TAVR.

The prognostic role of mitral regurgitation after primary percutaneous coronary intervention for acute ST-elevation myocardial infarction.

OBJECTIVES: The aim of this study was to elucidate the prognostic significance of mitral regurgitation (MR) after primary percutaneous coronary intervention (PCI) for acute ST-elevation myocardial infarction (STEMI). BACKGROUND: MR has prognostic implications after myocardial infarction (MI). However, for STEMI patients receiving primary PCI, the influence of MR on long-term (3-5 years) outcome is unknown. METHODS: We examined 888 STEMI patients receiving primary PCI enrolled in a prospective database at a regional STEMI center, who had an echocardiogram within 72 hr following successful primary PCI. MR was graded by color Doppler as none/trace vs. mild vs. moderate/severe. Mean ± SD follow-up was 3.1 ± 1.4 years. RESULTS: For patients with none/trace (n = 469), mild (n = 325), and moderate/severe (n = 94) MR, mortality at 3 years was 8.1%, 13.6%, and 25.7% and at 5 years was 12.7%, 18.3%, and 33.5%, respectively (P < 0.0001, log-rank test). Patients with moderate/severe MR tended to be older (P < 0.0001) with lower ejection fraction (P < 0.0001) and were less likely to have had an anterior MI (P < 0.001). Independent predictors of mortality included age, creatinine, and heart rate. CONCLUSIONS: Following primary PCI for STEMI, echocardiographic detected MR in the first 72 hr following PCI stratifies mortality risk. However, when accounting for age, MR is not an independent predictor of mortality.

Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients.

OBJECTIVES: 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). METHODS: 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. RESULTS: 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 mL; 95% CI -55.0 to -21.4; p<0.0001) and LV end-systolic volume (-14.6 mL; 95% CI -27.7 to -1.5; p=0.0303) compared with baseline. The New York Heart Association (NYHA) functional class improved from baseline to 5 years (p<0.005), and septal-lateral annular dimensions remained stable with no indication of mitral annular dilation through 5 years. CONCLUSIONS: The EVEREST II HRS demonstrated long-term safety and efficacy of MitraClip in high-surgical-risk patients through 5 years. The observed mortality was most likely a consequence of the advanced age and comorbidity profile of the enrolled patients, while improvements in NYHA class in surviving patients were durable through long-term follow-up. TRIAL REGISTRATION NUMBER: NCT01940120.

New Pulmonary Valvuloplasty Technique by Use of an Hourglass-Shaped Balloon in 3 Adults with Severe Pulmonary Valve Stenosis.

Percutaneous balloon pulmonary valvuloplasty is the preferred therapy for pulmonary valve stenosis. However, the designs of the cylindrical balloons historically used for valvuloplasty have limitations, especially in patients who have large pulmonary annular diameters. The hourglass-shaped V8 Aortic Valvuloplasty Balloon may prove to be an effective alternative. The balloon has 2 large bulbous segments that are separated by a narrowed waist. The geometric shape is maintained throughout inflation, improving fixation and enabling broader leaflet opening. We present our first experience with the V8 balloon in 3 adults who had severe, symptomatic pulmonary valve stenosis. In addition to describing their cases, we detail our sizing technique for pulmonary valvuloplasty with the V8 balloon. Our successful results suggest that the V8 balloon is efficient and safe for balloon pulmonary valvuloplasty in adults with severe pulmonary valve stenosis.

Contemporary Reasons and Clinical Outcomes for Patients With Severe, Symptomatic Aortic Stenosis Not Undergoing Aortic Valve Replacement.

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 with futility, potentially appropriate AVR patients had lower rates of both referral to cardiology or surgery (85.2% versus 92.6%; P=0.01) and complete heart team evaluations (10.6% versus 17.5%; P=0.02). Palliative consultation occurred in only 124 patients (22.6%) overall and in only 10.0% of those without futility. Overall, the 1-year mortality was 54.7%, with heart failure hospitalization occurring in 19.3%. CONCLUSIONS: In this contemporary study, two-thirds of patients with symptomatic aortic stenosis treated medically were potentially appropriate AVR candidates and had poor outcomes. Most had incomplete heart team evaluations, commonly had severe symptoms or lesion severity misinterpreted, and were not evaluated by palliative care. Given the potential for beneficial outcomes among those untreated, further efforts to address these shortcomings are needed.

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

OBJECTIVES: 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. METHODS: 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, procedural death, emergency surgery, or stroke). RESULTS: Forty InterValve balloon patients were matched with 40 cylindrical balloon patients. Postprocedure change in AVA trended strongly in favor of InterValve balloon patients (0.29 ± 0.17 cm² vs 0.22 ± 0.15 cm²; P=.06). Maximum balloon sizes were significantly smaller for InterValve balloon patients. Worsened AI occurred less frequently with InterValve balloons. There was no difference in postprocedure PPM implantations or major adverse events. CONCLUSIONS: Use of the hourglass-shaped balloons provided larger AVA, as compared with use of cylindrical balloons. Use of the novel balloons was not associated with an increase in AI, PPM, or major adverse events.

The right atrium and tricuspid annulus are cardinal structures in tricuspid regurgitation with or without pulmonary hypertension.

BACKGROUND: 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. METHODS: 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. RESULTS: 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 RA volume nor TAA were changed by PH. Indexed RV volume was insensitive to trace and mild TR, and PH similarly had little effect. CONCLUSIONS: RA volume and tricuspid annulus area enlarge in proportion to TR severity, trace through significant. PH impacts RA volume but only in trace and mild TR. RA volume best reflects TR impact on right heart structure, both with and without PH. Right atrial volume and tricuspid annulus area are the cardinal indices of TR-induced right heart structural disease et al.l severities. ULTRAMINI ABSTRACT: Right heart structural effects of TR and PH were examined in this study. Patients were evaluated by echo and CTA, and grouped by TR severity as trace, mild, and significant, and were subdivided by PH absence/presence. Analysis by TR severity and PH showed that Indexed RA volume is the parameter most sensitive to TR severity, and PH causes incremental RA volume increases in trace/mild TR. Indexed tricuspid annulus area (TAA) similarly increases with TR severity, but was unaffected by PH at any TR severity. RV volume is insensitive to TR severity and PH. Indexed right atrial volume and tricuspid annulus area are cardinal indices for TR-induced right heart structural disease and increase proportionally to TR severity. RA volume is more sensitive to PH than is tricuspid annular area. TR severity may be more accurately assessed by increased RA volume and annulus area. PERSPECTIVE STATEMENT: The right atrium (RA) and tricuspid annulus (TA) are the cardinal cardiac structures affected by tricuspid regurgitation (TR). They each enlarge with TR severity. The right ventricle exhibits minimal change across TR severity. Pulmonary hypertension (PH) enhances TR-mediated RA and TA dilation, but only in trace and mild TR. PH has no effect on RA, TA, or RV size in significant TR. CENTRAL MESSAGE: Right atrial volume and tricuspid annulus area are the most sensitive to TR severity, and are also sensitive to pulmonary hypertension.

First Experience With Percutaneous Mitral Valve Plication as Primary Therapy for Symptomatic Obstructive Hypertrophic Cardiomyopathy.

BACKGROUND: Few therapeutic options exist for patients with severe heart failure due to obstructive hypertrophic cardiomyopathy (HCM) who are at unacceptable surgical risk. We hypothesized that percutaneous plication of the mitral valve could reduce left ventricular outflow tract (LVOT) obstruction and associated mitral regurgitation, thereby leading to amelioration of heart failure symptoms. OBJECTIVES: This study sought to evaluate the potential effectiveness of percutaneous mitral valve plication as a therapy for patients with symptomatic, obstructive HCM. METHODS: Six patients (age 83 ± 8 years; 5 women), judged as not optimal candidates for septal myectomy, were referred for management of severe, drug-refractory heart failure symptoms due to obstructive HCM (New York Heart Association functional class III). Each underwent percutaneous mitral valve leaflet plication to reduce systolic anterior motion (SAM) and mitral regurgitation using the transcatheter mitral clip system. RESULTS: The procedure was completed in 5 patients with placement of a single clip at the A2-P2 segments of the mitral valve. One other patient experienced cardiac tamponade, leading to termination of the procedure. Among the 5 treated patients, percutaneous plication with the eliminated SAM and consequently decreased the intraoperative LVOT gradient (91 ± 44 mm Hg to 12 ± 6 mm Hg; p = 0.007), left atrial pressure (29 ± 11 mm Hg to 20 ± 8 mm Hg; p = 0.06), and mitral regurgitation grade (3.0 ± 0 vs. 0.8 ± 0.4; p = 0.0002) associated with improved cardiac output (in n = 4; 3.0 ± 0.6 l/min to 4.3 ± 1.2 l/min; p = 0.03). Over follow-up of 15 ± 4 months, symptom improvement to New York Heart Association functional class I or II occurred in all patients. Follow-up echocardiography after 15 ± 4 months demonstrated continued absence of SAM and significant reduction in mitral regurgitation, although high systolic LVOT velocities (i.e., >4 m/s) were evident in 3 of the 5 treated patients. CONCLUSIONS: This is a report of percutaneous mitral valve plication as a primary therapy in the management of severely symptomatic, obstructive HCM patients. This initial experience suggests that percutaneous mitral valve plication may be effective for symptom relief in such patients via reduction of SAM and mitral regurgitation. The significance of persistent elevations of LVOT velocities in some patients requires further study.

Initial Experience With Commercial Transcatheter Mitral Valve Repair in the United States.

BACKGROUND: Transcatheter mitral valve (MV) repair with the MitraClip received approval in 2013 for the treatment of prohibitive-risk patients with primary mitral regurgitation (MR). OBJECTIVES: The aim of this study was to report the initial U.S. commercial experience with transcatheter MV repair. METHODS: Data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with this percutaneous mitral valve repair device were analyzed. RESULTS: Of 564 patients (56% men, median age 83 years), severe symptoms were present in 473 (86.0%). The median Society of Thoracic Surgeons Predicted Risk of Mortality scores for MV repair and replacement were 7.9% (interquartile range: 4.7% to 12.2%) and 10.0% (interquartile range: 6.3% to 14.5%), respectively. Frailty was noted in 323 patients (57.3%). Transcatheter MV repair was performed for degenerative disease, present in 90.8% of patients. Overall, MR was reduced to grade ≤2 in 93.0%. In-hospital mortality was 2.3%; 30-day mortality was 5.8%. Other 30-day events were stroke (1.8%), bleeding (2.6%), and device-related complications (1.4%). The median length of stay was 3 days (interquartile range: 1 to 6 days), with 84.0% patients discharged home. Overall, procedure success occurred in 90.6%. Variables associated with reduction in MR were end-diastolic dimension, MR severity, clip location, and case volume. CONCLUSIONS: In this study of the initial commercial U.S. experience, it was found that procedural success was achieved in approximately 91% of patients, and the majority of patients were discharged home with moderate or less MR. These data support the effectiveness of this therapy in appropriately selected high-risk patients in a commercial setting. Further study is required to determine the long-term impact of transcatheter MV repair in this patient population.

Clinical, angiographic, and interventional follow-up of patients with aortic-saphenous vein graft connectors.

BACKGROUND: The use of aortic connectors for proximal saphenous vein bypass graft anastomoses eliminates the need for aortic clamping during coronary artery bypass grafting (CABG) and may reduce the incidence of stroke in the elderly and in patients with severe aortic atherosclerosis. METHODS AND RESULTS: We studied 74 consecutive patients who received the Symmetry Bypass System aortic connector at the time of CABG. A total of 131 of 144 proximal vein graft anastomoses were performed with this device. The left internal mammary artery was used in 62 patients, and 61 patients had "off-pump" coronary revascularization. A total of 11 patients were readmitted with chest pain consistent with unstable angina 173+/-39 days after CABG. Five of the 11 patients had previous in-stent restenosis before CABG. At angiography, 20 saphenous vein bypass grafts containing 19 connectors were found to have severe stenosis (n=12) or occlusion (n=6) and were treated with angioplasty and stenting or medical therapy. Seven of 11 patients were readmitted 76+/-11 days later with recurrent chest pain and were found to have severe stenosis at the previously stented connector site. Six patients underwent angioplasty followed by brachytherapy. Three of these patients redeveloped chest pain and were readmitted 151+/-71 days later. Two patients were started on oral Rapamune, and one patient underwent redo-CABG. CONCLUSIONS: Eleven of 74 patients who received aortic connectors at the time of CABG developed symptomatically significant stenosis or occlusion at the connector site shortly after CABG, requiring multiple repeat interventions, including brachytherapy.

Design of a standardized system for transfer of patients with ST-elevation myocardial infarction for percutaneous coronary intervention.

BACKGROUND: Direct percutaneous coronary intervention (PCI) is the preferred method of reperfusion for ST-elevation myocardial infarction (STEMI). Transfer from community hospitals to PCI centers increases availability for direct PCI, which improves outcomes compared to fibrinolysis in Europe. It has been difficult to achieve similar door-to-balloon times for transfer patients in the United States. METHODS: We designed a standardized protocol and integrated system of transfer for patients with STEMI. We report the door-to-balloon times for the pre- and postpilot patients in the index hospital and describe the details of the current Level 1 MI Program. RESULTS: In the 15 months before the pilot project, the door-to-balloon time for patients receiving ad hoc transfer for direct PCI was 192 minutes, similar to the national average. The door-to-balloon time for the patients receiving rescue PCI after failed thrombolysis was 221 minutes. The standardized protocol decreased door-to-balloon time to 98 minutes in the pilot trial (P < .01) and has now been applied successfully in 29 community hospitals. CONCLUSIONS: Rapid transfer of patients with STEMI is feasible in the United States using a standardized protocol and integrated transfer system. This requires a team approach with cooperation between cardiologists, emergency physicians, nurses, and the emergency medical system as well as various health care organizations.

Percutaneous repair of paravalvular prosthetic regurgitation: patient selection, techniques and outcomes.

Paravalvular prosthetic regurgitation is common, affecting 5-10% of surgical prostheses and 40-70% of transcatheter valves. While many patients may suffer no significant morbidity, paravalvular prosthetic regurgitation can lead to heart failure and haemolytic anaemia, and, in some studies, has been associated with impaired survival. Over the past several years, percutaneous repair of paravalvular prosthetic regurgitation has been demonstrated to be a highly efficacious therapy. When performed in experienced centres, procedural success with percutaneous repair occurs in 90% of patients. Due to the complex nature of the techniques, there is a significant learning curve with a high potential for prolonged procedures (∼2.5 h) and complications (∼5%), although death is rare (∼0.5%). Percutaneous repair of paravalvular prosthetic regurgitation requires a close collaboration between imaging specialists, surgeons and the interventional operators. Importantly, successful percutaneous repair obviates the need for open surgical correction, which can be high risk or prohibitive due to the need for reoperation in the setting of comorbidities. Herein, we discuss appropriate patient selection, the catheter-based techniques and outcomes of percutaneous repair for symptomatic paravalvular prosthetic regurgitation.

Use of cardiac CT angiography to assist in the diagnosis and treatment of aortic prosthetic paravalvular leak: a practical guide.

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.

Pathogenic structural heart changes in early tricuspid regurgitation.

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.

4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation.

OBJECTIVES: 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 3+ or 4+ 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 3+ or 4+ MR in the intention-to-treat population was 39.8% versus 53.4% in the percutaneous repair group and surgical groups, respectively (p = 0.070). Rates of death were 17.4% versus 17.8% (p = 0.914), and 3+ or 4+ MR was present in 21.7% versus 24.7% (p = 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. (Endovascular Valve Edge-to-Edge Repair Study [EVEREST II]; NCT00209274).