Long-term outcomes of phenoclusters in severe tricuspid regurgitation.

AIMS: Severe tricuspid regurgitation (TR) exhibits high 1-year morbidity and mortality, yet long-term cardiovascular risk overall and by subgroups remains unknown. This study characterizes 5-year outcomes and identifies distinct clinical risk profiles of severe TR. METHODS AND RESULTS: Patients were included from a large US tertiary referral center with new severe TR by echocardiography based on four-category American Society of Echocardiography grading scale between 2007 and 2018. Patients were categorized by TR etiology (with lead present, primary, and secondary) and by supervised recursive partitioning (survival trees) for outcomes of death and the composite of death or heart failure hospitalization. The Kaplan-Meier estimates and Cox regression models were used to evaluate any association by (i) TR etiology and (ii) groups identified by survival trees and outcomes over 5 years. Among 2379 consecutive patients with new severe TR, median age was 70 years, 61% were female, and 40% were black. Event rates (95% confidence interval) were 30.9 (29.0-32.8) events/100 patient-years for death and 49.0 (45.9-52.2) events/100 patient-years for the composite endpoint, with no significant difference by TR etiology. After applying supervised survival tree modeling, two separate groups of four phenoclusters with distinct clinical prognoses were separately identified for death and the composite endpoint. Variables discriminating both outcomes were age, albumin, blood urea nitrogen, right ventricular function, and systolic blood pressure (all P < 0.05). CONCLUSION: Patients with newly identified severe TR have high 5-year risk for death and death or heart failure hospitalization. Partitioning patients using supervised survival tree models, but not TR etiology, discriminated clinical risk. These data aid in identifying relevant subgroups in clinical trials of TR and clinical risk/benefit analysis for TR therapies.

The outcome of mitral repair for degenerative versus ischemic mitral regurgitation using a single complete ring.

BACKGROUND: The durability of surgical repair for degenerative versus ischemic mitral regurgitation (MR) is thought to be markedly different. We, therefore, examined late outcomes and durability for mitral repair in a large cohort of patients receiving a single annuloplasty device. METHODS: A total of 749 consecutive patients receiving mitral repair for degenerative mitral regurgitation (DMR) or ischemic mitral regurgitation (IMR) were evaluated from a prospective database. Patients with tricuspid or maze surgery were included. Papillary muscle rupture and mixed valve etiologies were excluded. Outcomes were compared for IMR versus DMR. RESULTS: Patients with DMR were younger and less urgent. Patients with IMR had mean end-systolic diameter 4.5 ± 1.1 cm. All patients received the same complete semirigid annuloplasty device with median ring size 32 mm for DMR and 24 mm for IMR. New York Heart Association failure class improved from 2.8 to 1.5 (p < .001). Patients with DMR had lower operative mortality (1/384 [0.3%] vs. 26/365 [7%], p < .0001) and shorter length of stay. A 15-year survival was better with DMR (63% ± 3% vs. 13% ± 2%, p < .001). At 10 years, the incidence of recurrent ≥2+ MR (10% ± 2% vs. 16% ± 2%, p = .16) was not significantly different. Predictors of recurrent ≥2+ MR were female gender (odds ratio [OR]: 3.0 (1.9-4.8, p < .0001), and prior operation (OR: 2.4 [1.3-4.5], p = .02) but not IMR (OR: 1.4 [0.9-2.3], p = .15). CONCLUSIONS: In this series, where patients with IMR had relatively preserved ventricular dimensions, the primary determinants of late recurrent MR were female gender and prior operation but not IMR versus DMR. Selected patients with IMR can obtain relatively durable mitral repair despite higher operative risk and lower survival compared to DMR.

Is this a bridge too far?

Maeda et al. present what may be the second reported case of transcatheter aortic valve replacement (TAVR) followed by staged open surgical aortic valve replacement (SAVR) in a high-risk patient. The authors propose that TAVR may serve as a bridge procedure before SAVR for aortic stenosis in selected younger patients with high surgical risk. Further experience may clarify how long to wait after TAVR to perform SAVR. Timing will be a balance between improving surgical risk versus increasing difficulty removing the prosthesis. Knowledge of TAVR durability will ultimately be needed to decide between "destination" TAVR versus bridging to SAVR with a more durable device.

Is redo mitral mortality getting better or getting worse?

Zubarevich et al. present the 30 day and 1-year outcomes of redo mitral valve replacement in 58 high-risk patients. The authors conclude that careful patient selection and risk stratification provides acceptable surgical results in this cohort. This series reminds us that increased use of bioprostheses, increased use of mitral replacement instead of repair, and an aging population drive the volume of high-risk redo mitral replacement. It remains to be seen whether redo mitral mortality is getting better or worse, but the risk and the patients will be with us for some time.

Bicuspid aortic valve repair: An ongoing struggle in material science.

BACKGROUND: Techniques and results of aortic valve repair remain challenging. AIMS: Safari et al. seek to improve aortic valve repair by either aortic patching or valve sparing root replacement. MATERIALS AND METHODS: The results of bicuspid aortic valve (BAV) repair in 142 patients were examined withor without valve sparing root replacement. RESULTS: Isolated BAV repair with or without valve sparing root replacement provided goodclinical outcomes with relatively low reoperation rate and durable valve function. DISCUSSION: While clinical outcome from BAV repair was generally good, the authors have stopped pericardial patch augmentation of BAV leaflets due to suboptimal durability. CONCLUSION: Thelack of a durable valve patch material and the modest durability of BAV repairin general point out that aortic valve repair remains an ongoing struggle inmaterial science.

Surgical risk scores: A roadmap to improved outcome?

Habertheuer et al. present a risk scoring system for predicting morbidity and mortality in 1181 patients undergoing surgery for drug associated endocarditis. The authors conclude that drug-related endocarditis is associated with significant morbidity and mortality and that an easily-applied risk stratification score may aid in clinical decision making. The authors demonstrate excellent predictive accuracy in a multi-institutional dataset, and the system is applicable to multivalve patients. Time will tell if application of this or other risk scoring systems can truly provide a roadmap to improved outcomes.

Robotic versus port-access mitral repair: A propensity score analysis.

BACKGROUND: Port-access (PORT) and robotic (ROBO) mitral repair are well established, but differences in patient selection and outcomes are not well documented. METHODS: A retrospective analysis was performed on 129 ROBO and 628 PORT mitral repairs at one institution. ROBO patients had 4 cm nonrib spreading incisions with robotic assistance, while PORT patients had 6-8 cm rib spreading incisions with thoracoscopic assistance. Propensity score analysis matched patients for differences in baseline characteristics. RESULTS: Unmatched ROBO patients were younger (58 ± 11 vs. 61 ± 13, p = .05), had a higher percentage of males (77% vs. 63%, p = .003) and had less NYHA Class 3-4 symptoms (11% vs. 21%, p < .01), less atrial fibrillation (19% vs. 29%, p = .02) and less tricuspid regurgitation (14% vs. 24%, p = .01). Propensity score analysis of matched patients showed that pump time (275 ± 57 vs. 207 ± 55, p < .0001) and clamp time (152 ± 38 vs. 130 ± 34, p < .0001) were longer for ROBO patients. However, length of stay, postoperative morbidity, and 5-year survival (97 ± 1% vs. 96 ± 3%, p = .7) were not different. For matched patients with degenerative valve disease, 5-year incidence of mitral reoperation (3 ± 2% vs. 1 ± 1%), severe mitral regurgitation (MR) (6 ± 4% vs. 1 ± 1%), or ≥2 + MR (12 ± 5% vs. 12 ± 4%), were not significantly different between ROBO versus PORT approaches. Predictors of recurrent moderate MR were connective tissue disease, functional etiology, and non-White race, but not surgical approach. CONCLUSIONS: In this first comparison out to 5 years, robotic versus port-access approach to mitral repair had longer pump and clamp times. Perioperative morbidity, 5-year survival, and 5-year repair durability were otherwise similar.

Long-term outcomes of aortic root replacement for endocarditis.

BACKGROUND: Infective endocarditis (IE) involving the aortic valve and root is associated with high risk requiring thoughtful surgical decision-making. The impact of valve and conduit choices and patient factors on long-term outcomes in this patient population is poorly documented. METHODS: From January 1976 to December 2013, 485 patients underwent aortic root and valve replacement at a single institution. Cox's proportional hazard model identified predictors of long-term survival and cumulative incidence functions were compared to assess need for reoperation with death as a competing risk. RESULTS: Median age at time of operation was 56.6 years (interquartile range: 23.1) with the indication for operation being endocarditis in 14.6% (n = 71). Stentless root replacement was used in 70% IE versus 34% non-IE (p < .001). Endocarditis at time of root replacement did not have a significant impact on survival through 15 years (IE: 37.3% vs. non-IE: 42.5%; log-rank; p = .13). After multivariable adjustment, survival was similar between patients with and without endocarditis (hazard ratio: 1.1; 95% confidence interval: [0.77, 1.62]; p = .57). Freedom from reoperation at 15 years did not vary significantly by endocarditis status (IE: 95.9% vs. non-IE: 73.6%; p = .07). Among endocarditis patients, freedom from reoperation at 10 years was similar between homograft and stentless bioprosthetic conduits (95.3% vs. 88.5%; log-rank; K-sample; p = .46). CONCLUSIONS: In a sample with frequent use of stentless prostheses, aortic root replacement for infective endocarditis had acceptable risk and long-term survival similar to root replacement for other indications. In the setting of endocarditis, root replacement with homograft or stentless bioprosthetic root has excellent durability through 15 years.

One-Year Outcomes After MitraClip for Functional Mitral Regurgitation.

BACKGROUND: Secondary mitral regurgitation (SMR) occurs in the absence of organic mitral valve disease and may develop as the left ventricle dilates or remodels or as a result of leaflet tethering with impaired coaptation, most commonly from apical and lateral distraction of the subvalvular apparatus, with late annular dilatation. The optimal therapy for SMR is unclear. This study sought to evaluate the 1-year adjudicated outcomes of all patients with SMR undergoing the MitraClip procedure in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) Investigational Device Exemption program, which is comprised of the randomized clinical trial, the prospective High-Risk Registry, and the REALISM Continued Access Registry (Multicenter Study of the MitraClip System). METHODS: Patients with 3+/4+ SMR enrolled in EVEREST II were stratified by non-high surgical risk (non-HR) and high surgical risk (HR) status (defined as Society of Thoracic Surgeons risk of mortality ≥12% or predefined risk factors). Clinical, echocardiographic, and functional outcomes at 1 year were evaluated. RESULTS: A total of 616 patients (482 HR, 134 non-HR; mean age, 73.3±10.5 years; Society of Thoracic Surgeons risk, 10.2±6.9%) with SMR underwent the MitraClip procedure. At baseline, 80.5% of patients were in New York Heart Association class III/IV. Major adverse events at 30 days included death (3.6%), stroke (2.3%), and renal failure (1.5%). At discharge, 88.8% had MR ≤2+. At 1 year, there were 139 deaths, and the Kaplan-Meier estimate of freedom from mortality was 76.8%. The majority of surviving patients (84.7%) remained with MR ≤2+ and New York Heart Association class I/II (83.0%). Kaplan-Meier survival at 1 year was 74.1% in HR patients and 86.4% in non-HR patients ( P=0.0175). At 1 year, both groups achieved comparable MR reduction (MR ≤2+, 84.0% versus 87.0%) and improvement in left ventricular end-diastolic volume (-8.0 mL versus -12.7 mL), whereas New York Heart Association class I/II was found in 80.1% versus 91.8% ( P=0.008) of HR and non-HR patients, respectively. In HR patients, the annualized rate of heart failure hospitalizations decreased from 0.68 to 0.46 in the 12 months before to 12 months after the procedure ( P<0.0001). CONCLUSIONS: Transcatheter mitral valve repair with the MitraClip in patients with secondary MR is associated with acceptable safety, reduction of MR severity, symptom improvement, and positive ventricular remodeling. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov . Unique identifiers: NCT00209274, NCT01940120, and NCT01931956.

Valvular Disease in Marfan Syndrome: Surgical Considerations and Management.

PURPOSE OF REVIEW: Detail the current strategies for the management of valve dysfunction in Marfan syndrome (MFS), understand the limitations of surgical interventions, and delineate the likely direction of future innovations. RECENT FINDINGS: Significant advances in both medical and surgical management of MFS have been made over the last 50 years. This has resulted in improved overall outcomes. As MFS patients age, new clinical challenges that were once rare have emerged and can require complex care strategies. Medical management has seen advances and focuses on anti-impulse and molecular-based pharmacotherapy, along with close monitoring with serial imaging to minimize acute aortic dissection risk by selecting appropriate timing of prophylactic surgical intervention with increasing aortic dimensions. Ongoing trials are evaluating other potential drug therapies with the ultimate goal of targeted treatment. Over the last 50 years, significant advances have been made in the understanding and management of MFS. A move to prophylactic surgery for aortopathy and valve disease has progressed from a valve replacement to a valve-sparing strategy in many cases. However, the durability of these repairs is variable and the possibility of reintervention looms.

Task-related changes in degree centrality and local coherence of the posterior cingulate cortex after major cardiac surgery in older adults.

OBJECTIVES: Older adults often display postoperative cognitive decline (POCD) after surgery, yet it is unclear to what extent functional connectivity (FC) alterations may underlie these deficits. We examined for postoperative voxel-wise FC changes in response to increased working memory load demands in cardiac surgery patients and nonsurgical controls. EXPERIMENTAL DESIGN: Older cardiac surgery patients (n = 25) completed a verbal N-back working memory task during MRI scanning and cognitive testing before and 6 weeks after surgery; nonsurgical controls with cardiac disease (n = 26) underwent these assessments at identical time intervals. We measured postoperative changes in degree centrality, the number of edges attached to a brain node, and local coherence, the temporal homogeneity of regional functional correlations, using voxel-wise graph theory-based FC metrics. Group × time differences were evaluated in these FC metrics associated with increased N-back working memory load (2-back > 1-back), using a two-stage partitioned variance, mixed ANCOVA. PRINCIPAL OBSERVATIONS: Cardiac surgery patients demonstrated postoperative working memory load-related degree centrality increases in the left dorsal posterior cingulate cortex (dPCC; p < .001, cluster p-FWE < .05). The dPCC also showed a postoperative increase in working memory load-associated local coherence (p < .001, cluster p-FWE < .05). dPCC degree centrality and local coherence increases were inversely associated with global cognitive change in surgery patients (p < .01), but not in controls. CONCLUSIONS: Cardiac surgery patients showed postoperative increases in working memory load-associated degree centrality and local coherence of the dPCC that were inversely associated with postoperative global cognitive outcomes and independent of perioperative cerebrovascular damage.

Long-term outcomes of mitral regurgitation by type and severity.

BACKGROUND: We aimed to determine the association of MR severity and type with all-cause death in a large, real-world, clinical setting. METHODS: We reviewed full echocardiography studies at Duke Echocardiography Laboratory (01/01/1995-12/31/2010), classifying MR based on valve morphology, presence of coronary artery disease, and left ventricular size and function. Survival was compared among patients stratified by MR type and baseline severity. RESULTS: Of 93,007 qualifying patients, 32,137 (34.6%) had ≥mild MR. A total of 8094 (8.7%) had moderate/severe MR, which was primary myxomatous (14.1%), primary non-myxomatous (6.2%), secondary non-ischemic (17.0%), and secondary ischemic (49.4%). At 10 years, patients with primary myxomatous MR or MR due to indeterminate cause had survival rates of >60%; primary non-myxomatous, secondary ischemic, and non-ischemic MR had survival rates <50%. While mild (HR 1.06, 95% CI 1.03-1.09), moderate (HR 1.31, 95% CI 1.27-1.37), and severe (HR 1.55, 95% CI 1.46-1.65) MR were independently associated with all-cause death, the relationship of increasing MR severity with mortality varied across MR types (P ≤ .001 for interaction); the highest risk associated with worsening severity was seen in primary myxomatous MR followed by secondary ischemic MR and primary non-myxomatous MR. CONCLUSIONS: Although MR severity is independently associated with increased all-cause death risk for most forms of MR, the absolute mortality rates associated with worse MR severity are much higher for primary myxomatous, non-myxomatous, and secondary ischemic MR. The findings from this study support carefully defining MR by type and severity.

Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial.

BACKGROUND: Patients with heart failure (HF) and symptomatic secondary mitral regurgitation (SMR) have a poor prognosis, with morbidity and mortality directly correlated with MR severity. Correction of isolated SMR with surgery is not well established in this population, and medical management remains the preferred approach in most patients. The Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial was designed to determine whether transcatheter mitral valve (MV) repair with the MitraClip device is safe and effective in patients with symptomatic HF and clinically significant SMR. STUDY DESIGN: The COAPT trial is a prospective, randomized, parallel-controlled, open-label multicenter study of the MitraClip device for the treatment of moderate-to-severe (3+) or severe (4+) SMR (as verified by an independent echocardiographic core laboratory) in patients with New York Heart Association class II-IVa HF despite treatment with maximally tolerated guideline-directed medical therapy (GDMT) who have been determined by the site's local heart team as not appropriate for MV surgery. A total of 614 eligible subjects were randomized in a 1:1 ratio to MV repair with the MitraClip plus GDMT versus GDMT alone. The primary effectiveness end point is recurrent HF hospitalizations through 24 months, analyzed when the last subject completes 12-month follow-up, powered to demonstrate superiority of MitraClip therapy. The primary safety end point is a composite of device-related complications at 12 months compared to a performance goal. Follow-up is ongoing, and the principal results are expected in late 2018. CONCLUSIONS: HF patients with clinically significant SMR who continue to be symptomatic despite optimal GDMT have limited treatment options and a poor prognosis. The randomized COAPT trial was designed to determine the safety and effectiveness of transcatheter MV repair with the MitraClip in symptomatic HF patients with moderate-to-severe or severe SMR.

Cardiovascular events and hospital resource utilization pre- and post-transcatheter mitral valve repair in high-surgical risk patients.

MitraClip is an approved therapy for mitral regurgitation (MR); however, health care resource utilization pre- and post-MitraClip remains understudied. METHODS: Patients with functional and degenerative MR at high surgical risk in the EVEREST II High-Risk Registry and REALISM Continued-Access Study were linked to Medicare data. Pre- and post-MitraClip all-cause death, stroke, myocardial infarction, heart failure (HF), and bleeding hospitalizations were identified. Inpatient costs, adjusted to 2010 US dollars, were calculated, and event rate ratios and cost ratios were estimated with multivariable modeling. RESULTS: Among 403 linked patients, the mean age was 80 years, 60% were male, mean baseline left ventricular ejection fraction was 49.6%, 83.3% were New York Heart Association class III/IV, 78.2% were MR grade 3+/4+, and 63.3% had functional MR. All-cause hospitalization decreased from 1,854 to 1,435/1,000 person-years (P<.001). HF hospitalization decreased following MitraClip (749 vs 332/1000 person-years, P<.001), but bleeding increased (199 vs 298/1000 person-years, P<.001). Changes in stroke and myocardial infarction were not statistically significant. Overall mean Medicare costs per patient were similar pre- and post-MitraClip, although there was a significant decrease in mean costs among those that survived a full year after MitraClip ($18,131 [SD $25,130] vs $11,679 [SD $22,486], P=.02). CONCLUSIONS: MitraClip was associated with a reduced rate of all-cause and HF hospitalizations and an increased rate of bleeding hospitalizations. One-year Medicare costs were reduced in those who survived a full year after the MitraClip procedure. Payors and providers seeking to reduce HF hospitalizations and associated Medicare costs may consider MitraClip among appropriate patients likely to survive 1 year.

Use of Adjuncts Reduces Cardiopulmonary Bypass Time During Minimally Invasive Aortic Valve Replacement.

BACKGROUND: Minimally invasive aortic valve replacement (MIAVR) through a mini-thoracotomy is comparable to AVR through a sternotomy, but may have increased surgical times. The development of adjuncts such as the automatic knot fastener and percutaneous coronary sinus (CS) catheter may reduce this disadvantage. METHODS: A retrospective review conducted between 2002 and 2015 at a single institution revealed 78 patients who underwent MIAVR with adjuncts. The automatic knot fastener was used on all patients, and a successful CS catheter was placed and confirmed by echocardiography in 67 patients (86%). Patients were propensity matched against those who had MIAVR without adjuncts (n = 78) and through a median sternotomy (n = 78) for assessment of major morbidity. Variables were compared using an unpaired t-test, Wilcoxon rank sum test, chi-squared and Fisher's exact test where appropriate. RESULTS: Patients who underwent MIAVR with adjuncts had shorter cross-clamp times (70.5 versus 108.1 and 84.4 min; p <0.0001) and cardiopulmonary bypass (CPB) times (101.1 versus 166.12 and 127.7 min; p <0.0001) than those who underwent MIAVR without adjuncts or through a median sternotomy. Patients who underwent MIAVR received fewer blood transfusions compared to those undergoing AVR via a median sternotomy (0.6 and 1.2 versus 2.5; p <0.012). Patients who underwent MIAVR with adjuncts had similar rates of new-onset atrial fibrillation (AF) than those undergoing MIAVR without adjuncts (33% versus 22%; p = 0.11), but had higher rates of AF compared to the sternotomy group (33% versus 17%; p = 0.02). Rates of in-hospital morbidity and mortality were similar between all groups. CONCLUSIONS: The use of adjuncts during MIAVR led to a significant shortening of cross-clamp and CPB times, and to a requirement for fewer blood transfusions. Morbidity and mortality rates after MIAVR were similar to those in patients undergoing a median sternotomy.

Trans-aortic Alfieri stitch at the time of septal myectomy for hypertrophic obstructive cardiomyopathy.

BACKGROUND: Systolic anterior motion (SAM) of the mitral valve, left ventricular outflow tract (LVOT) obstruction, and mitral regurgitation (MR) are known adverse outcomes that can occur after septal myectomy for hypertrophic obstructive cardiomyopathy. The objective of this study was to describe outcomes of a surgical technique to prevent these complications. METHODS: We have adopted a technique where we place an Alfieri stitch in the mitral valve through the aortotomy while performing septal myectomy. A retrospective review was performed and outcomes associated with this technique were noted. RESULTS: Twenty-four patients underwent septal myectomy and mitral valve repair using this technique. Mean age was 57 ± 10 years. Twenty patients were in class III/IV heart failure, and all had documented SAM. Mean LVOT gradient improved from 78 ± 48 mmHg preoperatively to 19 ± 20 mmHg after myectomy (p < 0.001). No patients had postoperative SAM, and no patients required a second aortic crossclamping for mitral repair. Seventeen of 19 patients with ≥mild MR had improvement in MR. During follow-up, 16 patients had no/trivial MR, seven had mild MR, and one had moderate MR. The mean postoperative mitral gradient was 4.5 ± 3.0 mmHg. Thirteen patients had postoperative complications including one death in a patient who developed a ventricular septal defect. CONCLUSIONS: Trans-aortic Alfieri stitch placement during septal myectomy is feasible in most cases as an additional tool to improve MR and minimize SAM. This technique may have a role in addressing mitral disease, such as a long anterior leaflet or fibrotic mitral valve, at the time of myectomy without the need for left atriotomy for mitral exposure.

Catastrophic antiphospholipid syndrome after cardiac surgery.

We report a case of catastrophic antiphospholipid syndrome in a patient following mitral valve replacement. The pathophysiology and management of this rare condition is discussed.

Management and outcomes in patients with moderate or severe functional mitral regurgitation and severe left ventricular dysfunction.

AIMS: The management and outcomes of patients with functional moderate/severe mitral regurgitation and severe left ventricular (LV) systolic dysfunction are not well defined. We sought to determine the characteristics, management strategies, and outcomes of patients with moderate or severe mitral regurgitation (MR) and LV systolic dysfunction. METHODS AND RESULTS: For the period 1995-2010, the Duke Echocardiography Laboratory and Duke Databank for Cardiovascular Diseases databases were merged to identify patients with moderate or severe functional MR and severe LV dysfunction (defined as LV ejection fraction ≤ 30% or LV end-systolic diameter > 55 mm). We examined treatment effects in two ways. (i) A multivariable Cox proportional hazards model was used to assess the independent relationship of different treatment strategies and long-term event (death, LV assist device, or transplant)-free survival among those with and without coronary artery disease (CAD). (ii) To examine the association of mitral valve (MV) surgery with outcomes, we divided the entire cohort into two groups, those who underwent MV surgery and those who did not; we used inverse probability weighted (IPW) propensity adjustment to account for non-random treatment assignment. Among 1441 patients with moderate (70%) or severe (30%) MR, a significant history of hypertension (59%), diabetes (28%), symptomatic heart failure (83%), and CAD (52%) was observed. Past revascularization in 26% was noted. At 1 year, 1094 (75%) patients were treated medically. Percutaneous coronary intervention was performed in 114 patients, coronary artery bypass graft (CABG) surgery in 82, CABG and MV surgery in 96, and MV surgery alone in 55 patients. Among patients with CAD, compared with medical therapy alone, the treatment strategies of CABG surgery [hazard ratio (HR) 0.56, 95% confidence interval (CI) 0.42-0.76] and CABG with MV surgery (HR 0.58, 95% CI 0.44-0.78) were associated with long-term, event-free survival benefit. Percutaneous intervention treatment produced a borderline result (HR 0.78, 95% CI 0.61-1.00). However, the relationship with isolated MV surgery did not achieve statistical significance (HR 0.64, 95% CI 0.33-1.27, P = 0.202). Among those with CAD, following IPW adjustment, MV surgery was associated with a significant event-free survival benefit compared with patients without MV surgery (HR 0.71, 95% CI 0.52-0.95). In the entire cohort, following IPW adjustment, the use of MV surgery was associated with higher event-free survival (HR 0.69, 95% CI 0.53-0.88). CONCLUSION: In patients with moderate or severe MR and severe LV dysfunction, mortality was substantial, and among those selected for surgery, MV surgery, though performed in a small number of patients, was independently associated with higher event-free survival.

Percutaneous repair or surgery for mitral regurgitation.

BACKGROUND: Mitral-valve repair can be accomplished with an investigational procedure that involves the percutaneous implantation of a clip that grasps and approximates the edges of the mitral leaflets at the origin of the regurgitant jet. METHODS: We randomly assigned 279 patients with moderately severe or severe (grade 3+ or 4+) mitral regurgitation in a 2:1 ratio to undergo either percutaneous repair or conventional surgery for repair or replacement of the mitral valve. The primary composite end point for efficacy was freedom from death, from surgery for mitral-valve dysfunction, and from grade 3+ or 4+ mitral regurgitation at 12 months. The primary safety end point was a composite of major adverse events within 30 days. RESULTS: At 12 months, the rates of the primary end point for efficacy were 55% in the percutaneous-repair group and 73% in the surgery group (P=0.007). The respective rates of the components of the primary end point were as follows: death, 6% in each group; surgery for mitral-valve dysfunction, 20% versus 2%; and grade 3+ or 4+ mitral regurgitation, 21% versus 20%. Major adverse events occurred in 15% of patients in the percutaneous-repair group and 48% of patients in the surgery group at 30 days (P<0.001). At 12 months, both groups had improved left ventricular size, New York Heart Association functional class, and quality-of-life measures, as compared with baseline. CONCLUSIONS: Although percutaneous repair was less effective at reducing mitral regurgitation than conventional surgery, the procedure was associated with superior safety and similar improvements in clinical outcomes. (Funded by Abbott Vascular; EVEREST II ClinicalTrials.gov number, NCT00209274.).

Dynamic indices of mitral valve function using perioperative three-dimensional transesophageal echocardiography.

OBJECTIVE: Perioperative transesophageal echocardiography is essential for decision-making for mitral valve surgery. While two-dimensional transesophageal echocardiography represents the standard of care, tracking of dynamic changes using three-dimensional imaging permits assessment of morphologic and functional characteristics of the mitral valve. The authors hypothesized that quantitative three-dimensional analysis would reveal distinct differences among diseased, repaired, and normal mitral valves. DESIGN: Case-control observational clinical study. SETTING: Tertiary care hospital. PARTICIPANTS: Using novel mitral valve quantification software, the authors retrospectively analyzed 80 datasets of cardiac surgery patients who underwent intraoperative transesophageal echocardiographic imaging. Twenty patients with degenerative mitral regurgitation were evaluated before and after mitral valve repair. Twenty patients had functional mitral regurgitation, and 20 patients had no mitral valve disease. MEASUREMENTS AND MAIN RESULTS: Primary outcome measures of dynamic mitral valve function were: 1) three-dimensional annulus area, 2) annular displacement distance, 3) annular displacement velocity, and 4) annular area fraction. Other mitral annular tracking indices, in addition to intraobserver reliability and interobserver agreement, also were reported. Annulus area was enlarged in degenerative and functional mitral regurgitation. Annular displacement distance was decreased in functional mitral regurgitation and repaired valves. Annular displacement velocity was decreased in functional mitral regurgitation. Annular area fraction was decreased in functional mitral regurgitation and repaired valves. Intraobserver reliability and interobserver agreement were high for all 4 analyzed indices. CONCLUSIONS: Normal, functional regurgitant, degenerative, and repaired mitral valves have distinctly different dynamic signatures of anatomy and function as reliably determined by perioperative echocardiographic tracking.