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Mitral valve repair is infrequently performed in patients undergoing corrective surgery for failed mitral transcatheter edge-to-edge repair in current United States practice. This article describes surgical techniques for reconstructive surgery after failed transcatheter edge-to-edge repair. Nine patients underwent robotic-assisted mitral surgery after failed transcatheter edge-to-edge repair between 2008 and 2020 at a single center. Repair was completed in 88.9% (n = 8) patients, and freedom from2+ mitral regurgitation was 87.5% (n = 7) at a median follow-up of 1.9 years.

Acutely decompensated heart failure presents a complicated challenge. Established temporary support measures have significant adverse effects. A minimally invasive temporary left ventricular assist device (LVAD), the Impella 5.0 (Abiomed, Danvers, MA), has been developed to support these patients.Patients with acutely decompensated heart failure in whom medical management had failed and who required additional support using an Impella 5.0 device were evaluated from January 2014 to September 2018 at a single center in a retrospective manner using a prospectively maintained database. Patients were treated with the device as a bridge to recovery (BTR; n = 30), bridge to durable device (BTDD; n = 23), or bridge to transplantation (BTT; n = 47). All devices were placed using an axillary artery approach. Demographic features and outcomes were evaluated for each group and compared.A total of 100 patients underwent insertion of an axillary Impella 5.0 LVAD. Patients had an average age of 56.7 ± 13.2 years, were predominantly male (84%), and had a severely depressed left ventricular ejection fraction (average 16%), and most had an Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 (57%) or 2 (33%) score. When divided into groups, there was no difference in age or INTERMACS score, but a statistical difference was noted in baseline left ventricular ejection fraction (20%, 14%, 15%) and creatinine level (1.0, 2.0, 1.6), in the BTR, BTDD, or BTT group, respectively (all P.05). Survival was 64% overall, and it was 50%, 48%, and 81% for BTR, BTDD, and BTT, respectively (P = .007). Survival improved during this experience and was 90% overall in the most recent 30 patients.Use of this minimally invasive LVAD system is an attractive strategy to support patients with acute decompensated heart failure to recovery, durable LVAD, or heart transplantation.

Objective Up to 28% of patients may need mitral valve (MV) surgery after transcatheter edge-to-edge repair (TEER). This study evaluates the outcomes of minimally invasive MV surgery after TEER. Methods: International multicenter registry of minimally invasive MV surgery after TEER between 2013 and 2020. Subgroups were stratified by the number of devices implanted (≤1 vs >1), as well as time interval from TEER to surgery (≤1 year vs >1 year). Results: A total of 56 patients across 13 centers were included with a mean age of 73 ± 11 years, and 50% were female. The median Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) score for MV replacement was 8% (Q1-Q3 = 5% to 11%) and the ratio of observed to expected mortality was 0.9. The etiology of mitral regurgitation (MR) prior to TEER was primary MR in 75% of patients and secondary MR in 25%. There were 30 patients (54%) who had >1 device implanted. The median time between TEER and surgery was 252 days (33 to 636 days). Hemodynamics, including MR severity, MV area, and mean gradient, significantly improved after minimally invasive surgery and sustained to 1-year follow-up. In-hospital and 30-day mortality was 7.1%, and 1-year actuarial survival was 85.6% ± 6%. Conclusions: Minimally invasive MV surgery after TEER may be achieved as predicted by the STS PROM. Most patients underwent MV replacement instead of repair. As TEER is applied more widely, patients should be informed about the potential need for surgical intervention over time after TEER. These discussions will allow better informed consent and post-procedure planning.

Importance There are limited data on outcomes of transcatheter aortic valve replacement (TAVR) for bicuspid aortic stenosis in patients at low surgical risk. Objective To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis in patients who are at low surgical risk. Design, setting, and participants Registry-based cohort study of patients undergoing TAVR at 684 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapies Registry from June 2015 to October 2020. Among 159 661 patients (7058 bicuspid, 152 603 tricuspid), 37 660 patients (3243 bicuspid and 34 417 tricuspid) who were at low surgical risk (defined as STS risk score Exposures TAVR for bicuspid vs tricuspid aortic stenosis. Main outcomes and measures Coprimary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications and valve hemodynamics. Results Among 159 661 patients (7058 bicuspid; 152 603 tricuspid), 3168 propensity-matched pairs of patients with bicuspid and tricuspid aortic stenosis at low surgical risk were analyzed (mean age, 69 years; 69.8% men; mean [SD] STS-predicted risk of mortality, 1.7% [0.6%] for bicuspid and 1.7% [0.7%] for tricuspid). There was no significant difference between the bicuspid and tricuspid groups' rates of death at 30 days (0.9% vs 0.8%; hazard ratio [HR], 1.18 [95% CI, 0.68-2.03]; P = .55) and at 1 year (4.6% vs 6.6%; HR, 0.75 [95% CI, 0.55-1.02]; P = .06) or stroke at 30 days (1.4% vs 1.2%; HR, 1.14 [95% CI, 0.73-1.78]; P = .55) and at 1 year (2.0% vs 2.1%; HR 1.03 [95% CI, 0.69-1.53]; P = .89).There were no significant differences between the bicuspid and tricuspid groups in procedural complications, valve hemodynamics (aortic valve gradient: 13.2 mm Hg vs 13.5 mm Hg; absolute risk difference [RD], 0.3 mm Hg [95% CI, -0.9 to 0.3 mm Hg]), and moderate or severe paravalvular leak (3.4% vs 2.1%; absolute RD, 1.3% [95% CI, -0.6% to 3.2%]). Conclusions and relevance In this preliminary, registry-based study of propensity-matched patients at low surgical risk who had undergone TAVR for aortic stenosis, patients treated for bicuspid vs tricuspid aortic stenosis had no significant difference in mortality or stroke at 30 days or 1 year. Because of the potential for selection bias and absence of a control group treated surgically for bicuspid aortic stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis in patients at low surgical risk.

To evaluate candidacy for surgical mitral valve (MV) repair of recurrent mitral regurgitation (MR) after failed MitraClip.Percutaneous mitral repair with MitraClip is safe and effective in patients with degenerative and functional MR with high surgical risk. However, some patients require subsequent mitral surgery for recurrence of significant MR.This single-center, observational study includes consecutive patients who underwent mitral surgery after failed MitraClip.Twenty-five patients (age, 69 ± 15 years; 52% women) with severe symptomatic MR after failed MitraClip implantation underwent mitral surgery after a median interval of 5.1 months (interquartile range, 2.5-14 months). Ten patients underwent MV repair (8 with robotic minithoracotomy) and 15 underwent MV replacement (most with sternotomy). Two patients in whom MV repair was intended underwent MV replacement because MitraClip-related leaflet damage prohibited repair. Examples of relative contraindication for MV repair that led to pursuing MV replacement were advanced patient age in 4 patients (mean age, 85 ± 7.6 years), endocarditis in 1 patient, and severely calcified or rheumatic leaflets in 5 patients. Perioperative complications were rare and intermediate-term mortality was similar between groups (3 patients in the MV repair group [30%] vs 4 patients in the MV replacement group [27%]; P=.90).When performed by an experienced mitral surgeon and within 1 year of failed MitraClip implantation, surgical MV repair is feasible in most patients who were surgical repair candidates before the clip. Having the option for surgical MV repair after failed MitraClip is important to preserve optimal long-term outcomes for patients who undergo transcatheter mitral repair with MitraClip, especially as ongoing trials are shifting to study lower-risk patients who are also candidates for surgical repair.

Variation in degenerative mitral morphology may contribute to suboptimal repair rates. This study evaluates outcomes of a standardized mitral repair technique.An institutional clinical registry was used to identify 1036 consecutive patients undergoing robotic mitral surgery between 2005 and 2020: 87% (n = 902) had degenerative disease. Calcification, failed transcatheter repair, and endocarditis were excluded, leaving 582 (68%) patients with isolated posterior leaflet and 268 (32%) with anterior or bileaflet prolapse. Standardized repair comprised triangular resection and true-sized flexible band in posterior leaflet prolapse. Freedom from greater than 2+ moderate mitral regurgitation stratified by prolapse location was assessed using competing risk analysis with death as a competing event. Median follow-up was 5.5 (range 0-15) years.Of patients with isolated posterior leaflet prolapse, 87% (n = 506) had standardized repairs and 13% (n = 76) had additional or nonresectional techniques vs 24% (n = 65) and 76% (n = 203), respectively, for anterior or bileaflet prolapse (P.001). Adjunctive techniques in the isolated posterior leaflet group included chordal reconstruction (8.6%, n = 50) and commissural sutures (3.4%, n = 20). Overall, median clamp time was 80 (interquartile range, 68-98) minutes, 17 patients required intraoperative re-repair, and 6 required mitral replacement. Freedom from greater than 2+ regurgitation or reintervention at 10 years was 92% for posterior prolapse (vs 83% for anterior or bileaflet prolapse). Anterior or bileaflet prolapse was associated with late greater than 2+ regurgitation (hazard ratio, 3.0; 95% confidence interval, 1.3-7.0).Posterior leaflet prolapse may be repaired in greater than 99% of patients using triangular resection and band annuloplasty, with satisfactory long-term durability. Increased risk of complex repairs and inferior durability highlights the value of identifying anterior and bileaflet prolapse preoperatively.

Background Indications for heart transplantation are expanding to include amyloid light chain (AL) and transthyretin-related (TTR) amyloidosis. Previously, AL amyloid had been a contraindication to heart transplantation given inferior outcomes. These patients typically have biventricular failure requiring mechanical circulatory support (MCS). We report the outcomes of patients with end-stage cardiac amyloidosis who underwent cardiac transplantation, including some who were bridged to transplantation with a durable biventricular MCS Methods The records for patients with cardiac amyloidosis who underwent cardiac transplant between 2010 and 2018 were reviewed. Primary endpoint was post-transplant 1-year survival. Secondary endpoints included 1-year freedom from cardiac allograft vasculopathy (as defined by stenosis ≥ 30% by angiography), nonfatal major adverse cardiac events (myocardial infarction, new congestive heart failure, percutaneous coronary intervention, implantable cardioverter defibrillator/pacemaker implant, stroke), and any rejection. Results A total of 46 patients received heart transplantation with a diagnosis of either AL or TTR amyloidosis. Of these, 7 patients were bridged to transplantation with a durable biventricular MCS device (6 AL, 1 TTR) and 39 patients were transplanted without MCS bridging. The MCS group consisted of 5 total artificial hearts and 2 biventricular assist devices. The 1-year survival was 91% for the entire cohort, 83% for those with AL amyloidosis, 94% for those with TTR amyloidosis, and 86% for those who received MCS bridging. Conclusions Cardiac transplantation can be safely performed in selected amyloidosis patients with reasonable short-term outcomes. Those bridged to transplantation with biventricular MCS appear to have short-term outcomes similar to those transplanted without MCS. Larger numbers and longer observation are required to confirm these findings.

Background The Placement of Aortic Transcatheter Valves 2A (PARTNER-2A) randomized trial compared outcomes of transfemoral transcatheter and surgical aortic valve replacement (SAVR) in intermediate-risk patients with severe aortic stenosis. The purpose of the present study was to perform an in-depth analysis of outcomes after SAVR in the PARTNER-2A trial. Methods From January 2012 to January 2014, 937 patients underwent SAVR at 57 centers. Mean age was 82 ± 6.7 years and 55% were men. Less-invasive operations were performed in 140 patients (15%) and concomitant procedures in 198 patients (21%). Major outcomes and echocardiograms were adjudicated by an independent events committee. Follow-up was 94% complete to 2 years. Results Operative mortality was 4.1% (n = 38, Society of Thoracic Surgeons predicted risk of mortality: 5.2% ± 2.3%), observed to expected ratio (O/E) was 0.8, and in-hospital stroke was 5.4% (n = 51), twice expected. Aortic clamp and bypass times were 75 ± 30 minutes and 104 ± 46 minutes, respectively. Patients having severe prosthesis–patient mismatch (n = 260, 33%) had similar survival to patients without ( p > 0.9), as did patients undergoing less-invasive SAVR ( p = 0.3). Risk factors for death included cachexia ( p = 0.004), tricuspid regurgitation ( p = 0.01), coronary artery disease ( p = 0.02), preoperative atrial fibrillation ( p = 0.001), higher white blood cell count ( p p = 0.0002). Conclusions In this adjudicated prospective study, SAVR in intermediate-risk patients had excellent results at 2 years. However, there were more in-hospital strokes than expected, most likely attributable to mandatory neurologic assessment after the procedure. No pronounced structural valve deterioration was found during 2-year follow-up. Continued long-term surveillance remains important.

Achieving minimal residual mitral regurgitation (MR) after percutaneous MitraClip repair is limited by iatrogenic mitral stenosis. It is unknown whether allowing moderately elevated postprocedural mean mitral gradients (MMGs) to achieve moderate residual MR is preferable to moderate residual regurgitation. Patients with less-than-moderate residual MR but a MMG of ≥5 mm Hg (Group 1) were compared with patients with moderate residual MR (Group 2). The primary end point was heart failure hospitalization. Secondary end points included mortality, subsequent mitral valve surgery, and MR at 1 year. Seventy-eight patients were included in the study. Group 1 included 48 patients (median MMG 6, interquartile range 5-6 mm Hg). Group 2 included 30 patients (median MMG 3.5, interquartile range 2-5 mm Hg). Age, baseline MR severity, and type of MR were not different between groups. Freedom from heart failure hospitalization at 1 year was 91.2 ± 4.2% in Group 1 versus 70.8 ± 8.7% in Group 2 (p = 0.021). Achieved differences in MR reduction between groups persisted at 1 year (p = 0.007). Survival was not different (p = 0.402), and subsequent mitral valve surgery occurred in 4 of 48 (8%) and in 4 of 30 patients (13%) in Group 1 and Group 2, respectively (p = 0.476). By multivariate Cox regression analysis, less-than-moderate residual MR, despite moderately elevated mitral gradients, was associated with a hazard ratio of 0.21 (95% confidence interval 0.04 to 0.96) for subsequent heart failure hospitalization (p = 0.044). In conclusion, patients with less-than-moderate residual MR despite a MMG of ≥5 had a 79% reduction in hazard for subsequent heart failure hospitalization compared with patients with moderate residual MR.

Percutaneous edge-to-edge repair using the MitraClip system causes reduction in mitral valve area (MVA). However, its clinical impact is not fully elucidated. This study assessed the impact of postprocedural MVA reduction on pulmonary hypertension and outcomes. A total of 92 patients with grades 3 to 4 + mitral regurgitation (MR) who underwent MitraClip therapy were retrospectively reviewed. Using intraprocedural, 3-dimensional transesophageal echocardiography, postprocedural MVA was obtained by 2 optimized planes through the medial and lateral orifices of the repaired valve. MVA was reduced by 60.1% immediately after MitraClip procedure (p0.001). Postprocedural MVA correlated moderately with mean transmitral pressure gradient (TMPG) in the majority of patients (r = -0.56, p0.001), but discordance of MVA and TMPG was observed in 40% of patients. In multivariable linear regression analysis, postprocedural MVA ≤1.94 cm

Background We report clinical experience with combined heart and kidney transplantation (HKTx) over a 23-year time period. Methods From June 1992 to August 2015, we performed 83 combined HKTx procedures at our institution. We compared the more recent cohort of 53 HKTx recipients (group 2, March 2009 to August 2015) with the initial 30 previously reported HKTx recipients (group 1, June 1992 to February 2009). Pre-operative patient characteristics, peri-operative factors, and post-operative outcomes including survival were examined. Results The baseline characteristics of the two groups were similar, except for a lower incidence of ethanol use and higher pre-operative left-ventricular ejection fraction, cardiac output, and cardiac index in group 2 when compared with group 1 (P = .007, .046, .037, respectively). The pump time was longer in group 2 compared with group 1 (153.30 ± 38.68 vs 129.60 ± 37.60 minutes; P = .007), whereas the graft ischemic time was not significantly different between the groups, with a trend to a longer graft ischemic time in group 2 versus group 1 (195.17 ± 45.06 vs 178.07 ± 52.77 minutes; P = .056, respectively). The lengths of intensive care unit (ICU) and hospital stay were similar between the groups (P = .083 and .39, respectively). In addition, pre-operative and post-operative creatinine levels at peak, discharge, 1 year, and 5 years and the number of people on post-operative dialysis were similar between the groups (P = .37, .75, .54, .87, .56, and P = .139, respectively). Overall survival was not significantly different between groups 2 and 1 for the first 5 years after transplant, with a trend toward higher survival in group 2 (P = .054). Conclusions The most recent cohort of combined heart and kidney transplant recipients had similar ICU and hospital lengths of stay and post-operative creatinine levels at peak, discharge, and 1 and 5 years and a similar number of patients on post-operative dialysis when compared with the initial cohort. Overall survival was not significantly different between the later and earlier groups, with a trend toward higher overall survival at 5 years in the more recent cohort of patients. In selected patients with co-existing heart and kidney failure, combined heart and kidney transplantation is safe to perform and has excellent outcomes.

Temporary mechanical circulatory support (MCS) devices are generally used short term to maintain adequate organ perfusion in patients with advanced heart failure and cardiogenic shock. Unacceptably high waitlist mortality in this cohort motivated changes to heart allocation policy, which recognized the severity of illness by prioritization for temporary MCS and broader sharing in the new U.S. donor heart allocation policy. We evaluated the post-heart transplant outcomes for patients bridged with temporary MCS, a control population not bridged with MCS, and a cohort bridged with durable MCS.The heart transplant research database was queried to identify patients bridged with temporary MCS and bridged with durable MCS who went directly to heart transplant in our center. Temporary MCS included Impella, intra-aortic balloon pump, and extracorporeal membrane oxygenation. Post-transplant endpoints were assessed at 30 days, 6 months, and 1 year.From 2010 to 2017, a total of 23 patients were bridged to heart transplant with temporary MCS and 548 were transplanted without MCS bridge. Patients bridged with temporary MCS had younger age, lower body mass index, and higher frequencies of prior blood transfusion and Status 1 (1A/1B) listing at transplant compared to patients not bridged with MCS (all P .001). Despite the severity of illness in patients bridged with temporary MCS, post-transplant outcomes were indistinguishable from those in patients transplanted without MCS bridge, with no difference in 30-day, 6-month, or 1-year survival or 1-year freedom from cardiac allograft vasculopathy, nonfatal major adverse cardiac events, any-treated rejection, acute cellular rejection, or antibody-mediated rejection (P = .23-.97). Similarly, compared to 157 patients bridged with durable MCS, no differences in post-transplant outcomes were identified for the temporary MCS cohort (P = .15-.94).Temporary MCS as a bridge to transplant achieves similar post-transplant outcomes at 1 year compared to no MCS and durable MCS. These encouraging findings support recent changes in the Organ Procurement and Transplantation Network | United Network Organ Sharing (OPTN|UNOS) adult heart allocation policy.

Tricuspid valve (TV) annuloplasty is an effective treatment for tricuspid regurgitation (TR). However, the impact of TV morphology on outcome of TV annuloplasty remains unknown. We sought to investigate the relationship between preoperative TV morphology and residual TR after annuloplasty.Two-dimensional transthoracic and three-dimensional (3D) transesophageal echocardiography were performed in 97 patients with functional TR before and after surgery. 3D quantitative assessment including annular dimension, tenting height and volume, and lengths and tethering angles of the 3 leaflets was performed. The TV morphological score was derived from the preoperative 3D echocardiography to score a leaflet mobility, leaflet thickening, subvalvular thickening, and calcification. TR severity was determined by the averaged vena contracta measured from the apical and parasternal inflow views. Multivariable analysis revealed that a shorter total leaflet length (P = 0.007), larger tenting volume (P 0.001), and higher TV morphological score (P 0.001) were independently associated with residual TR. A TV-Echo score was determined as a sum of points based on receiver operator characteristics analysis: total leaflet length 61.0 mm, 61.0 to 53.5 mm, and 53.5 mm; tenting volume 2.3 mL, 2.3 to 3.5 mL, and 3.5 mL; and TV morphological score 7, 7 to 18, and 18; each variable was associated with 0 and 1 point and 2 points, respectively. The TV-Echo score ≥2 was associated with significant residual TR with a sensitivity of 85.7% and a specificity of 71.0%.In addition to tethering and short length of the leaflets, TV morphological abnormality predicted residual TR after TV annuloplasty.

Background Longitudinal motion of the mitral annulus is an index that reflects left ventricular (LV) function. The aim of this study was to evaluate and compare the effects of transcatheter mitral valve (MV) repair and open heart surgery for mitral regurgitation (MR) on mitral annular motion (MAM). Methods We retrospectively analyzed in total 115 patients who underwent isolated transcatheter MV repair using MitraClip (n=50) or surgical MV interventions (n=65, 50 repairs and 15 replacements) for MR. MAM was assessed by two-dimensional B-mode echocardiography in the four- and two-chamber views. MAM was measured before and within 1 month after the mitral procedure. Results Compared with patients undergoing MV surgery, patients undergoing the MitraClip procedure were older and had more comorbidities. MR grade improved significantly in both groups after MV intervention. MAM decreased significantly in the surgery group (12.0±3.1 to 8.1±2.2 mm, P

The upper age limit of heart transplantation remains controversial. The goal of the present study was to investigate the mortality and morbidity of orthotopic heart transplantation (HT) for recipients ≥70 compared with those 70 years of age.Of 704 adults who underwent HT from December 1988 to June 2012 at our institution, 45 were ≥70 years old (older group) and 659 were 70 years old (younger group). Survival, intraoperative blood product usage, intensive care unit (ICU) and hospital stays, and frequency of reoperation for chest bleeding, dialysis, and48 hours ventilation were examined after HT.The older group had 100% 30-day and 60-day survival compared with 96.8 ± 0.7% 30-day and 95.9 ± 0.8% 60-day survival rates in the younger group. The older and younger groups had similar 1-year (93.0 ± 3.9% vs 92.1 ± 1.1%; P = .79), 5-year (84.2 ± 6.0% vs 73.4 ± 1.9%; P = .18), and 10-year (51.2 ± 10.7% vs 50.2 ± 2.5%; P = .43) survival rates. Recipients in the older group had higher preoperative creatinine levels, frequency of coronary artery disease, and more United Network for Organ Sharing status 2 and fewer status 1 designations than recipients in the younger group (P .05 for all). Pump time and intraoperative blood usage were similar between the 2 groups (P = NS); however, donor-heart ischemia time was higher in the older group (P = .002). Older recipients had higher postoperative creatinine levels at peak (P = .003) and at discharge (P = .007). Frequency of postoperative complications, including reoperation for chest bleeding, dialysis,48 hours ventilation, pneumonia, pneumothorax, sepsis, in-hospital and post-discharge infections, were similar between groups (P = NS for all comparisons). ICU and hospital length of stays were similar between groups (P = .35 and P = .87, respectively). In Cox analysis, recipient age ≥70 years was not identified as a predictor of lower long-term survival after HT.HT recipients ≥70 years old had similar 1, 5, and 10-year survival rates compared with younger recipients. Both patient groups had similar intra- and postoperative blood utilization and frequencies of many postoperative complications. Older and younger patients had similar morbidity and mortality rates following HT. Carefully selected older patients (≥70 years) can safely undergo HT and should not be excluded from HT consideration based solely on age.

The most recent American College of Cardiology/American Heart Association heart valve guidelines recommend that prompt surgical correction of severe degenerative mitral valve regurgitation, ideally mitral valve repair, should be performed to decrease the risks of long-term mortality and heart failure risks associated with this condition. Mitral valve repair performed using a minimally invasive robotic approach can now be successfully carried out in nearly all cases of degenerative disease with very low risks of stroke or death. Experienced groups have further shown specific advantages of robotic mitral valve repair compared with conventional approaches, including reduced blood loss, lower risks of infection and atrial fibrillation, shorter hospital length of stay, quicker return to normal activities, and a superior cosmetic result. Herein, we discuss the current status of robotic mitral valve repair including indications, technical advances, safety, effectiveness, and durability.

For patients with secondary mitral regurgitation (MR), the COAPT study showed that percutaneous edge-to-edge mitral valve (MV) repair with the MitraClip device, regardless of surgical risk, not only can reduce heart failure hospitalizations and all-cause mortality but is also safe [(1)][1]. The

The impact of prior implantation of a ventricular assist device (VAD) on short- and long-term postoperative outcomes of adult heart transplantation (HTx) was investigated.Of the 359 adults with prior cardiac surgery who underwent HTx from December 1988 to June 2012 at our institution, 90 had prior VAD and 269 had other (non-VAD) prior cardiac surgery.The VAD group had a lower 60-day survival when compared with the Non-VAD group (91.1% ± 3.0% vs 96.6% ± 1.1%; P = .03). However, the VAD and Non-VAD groups had similar survivals at 1 year (87.4% ± 3.6% vs 90.5% ± 1.8%; P = .33), 2 years (83.2% ± 4.2% vs 88.1% ± 2.0%; P = .21), 5 years (75.7% ± 5.6% vs 74.6% ± 2.9%; P = .63), 10 years (38.5% ± 10.8% vs 47.6% ± 3.9%; P = .33), and 12 years (28.9% ± 11.6% vs 39.0% ± 4.0%; P = .36). The VAD group had longer pump time and more intraoperative blood use when compared with the Non-VAD group (P.0001 for both). Postoperatively, VAD patients had higher frequencies of48-hour ventilation and in-hospital infections (P = .0007 and .002, respectively). In addition, more VAD patients had sternal wound infections when compared with Non-VAD patients (8/90 [8.9%] vs 5/269 [1.9%]; P = .005). Both groups had similar lengths of intensive care unit (ICU) and hospital stays and no differences in the frequencies of reoperation for chest bleeding, dialysis, and postdischarge infections (P = .19, .70, .34, .67, and .21, respectively). Postoperative creatinine levels at peak and at discharge did not differ between the 2 groups (P = .51 and P = .098, respectively). In a Cox model, only preoperative creatinine ≥1.5 mg/dL (P = .006) and intraoperative pump time ≥210 minutes (P = .022) were individually considered as significant predictors of mortality within 12 years post-HTx. Adjusting for both, pre-HTx VAD implantation was not a predictor of mortality within 12 years post-HTx (hazard ratio [HR], 1.23; 95% confidence interval [CI], 0.77-1.97; P = .38). However, pre-HTx VAD implantation was a risk factor for 60-day mortality (HR, 2.86; 95% CI, 1.07-7.62; P = .036) along with preoperative creatinine level ≥2 mg/dL (P = .0006).HTx patients with prior VAD had lower 60-day survival, higher intraoperative blood use, and greater frequency of postoperative in-hospital infections when compared with HTx patients with prior Non-VAD cardiac surgery. VAD implantation prior to HTx did not have an additional negative impact on long-term morbidity and survival following HTx. Long-term (1-, 2-, 5-, 10-, and 12-year) survival did not differ significantly in HTx patients with prior VAD or non-VAD cardiac surgery.

Purpose Combined heart-liver transplantation is an increasingly accepted treatment for select patients with heart and liver disease. Despite growing optimism, heart-liver transplantation remains an infrequent operation. We report our institutional experience with heart-liver transplantation. Methods All combined heart-liver transplantations at Cedars-Sinai Medical Center from 1998–2014 were analyzed. Primary outcomes were patient and graft survival and secondary outcomes included rejection, infection, reoperation, length of stay, and readmission. Results There were 7 heart-liver transplants: 6 simultaneous (single donor) and 1 staged (2 donors). Median follow-up was 22.1 (IQR 13.2–48.4) months. Mean recipient age was 50.8 ± 19.5 years. Heart failure etiologies included familial amyloidosis, congenital heart disease, hypertrophic cardiomyopathy, systemic lupus erythematosus, and dilated cardiomyopathy. Preoperative left ventricular ejection fraction averaged 32.3 ± 12.9%. Five (71.4%) patients required preoperative inotropic support; 1 required mechanical circulatory support. The most common indications for liver transplant were amyloidosis and cardiac cirrhosis. Median Model for End-stage Liver Disease score was 10.0 (9.3–13.8). Six-month and 1-year actuarial survivals were 100% and 83.3%, with mean survival exceeding 4 years. No patient experienced cardiac allograft rejection, 1 experienced transient liver allograft rejection, and 1 developed progressive liver dysfunction resulting in death. Five developed postoperative infections and 3 (42.9%) required reoperation. Median ICU and hospital stays were 7.0 (7.0–11.5) and 17.0 (13.8–40.5) days. There were 4 (57.1%) readmissions. Conclusions For carefully selected patients with coexisting heart and liver disease, combined heart and liver transplantation offers acceptable patient and graft survival.

This study investigated the effect of prior sternotomy (PS) on the postoperative mortality and morbidity after orthotopic heart transplantation (HTx).Of 704 adults who underwent HTx from December 1988 to June 2012 at a single institution, 345 had no PS (NPS group) and 359 had ≥ 1 PS (PS group). Survival, intraoperative use of blood products, intensive care unit (ICU) and hospital stays, frequency of reoperation for bleeding, dialysis, and48-hour ventilation were examined.The NPS and PS groups had similar 60-day survival rates (97.1 ± 0.9% vs 95.3 ± 1.1%; P = .20). However, the 1-year survival was higher in the NPS group (94.7 ± 1.2% vs 89.7 ± 1.6%; hazard ratio [HR], 1.98; 95% CI, 1.12-3.49; P = .016). The PS group had longer pump time and more intraoperative blood use (P.0001 for both). Postoperatively, the PS group had longer ICU and hospital stays, and higher frequencies of reoperation for bleeding and48-hour ventilation (P.05 for all comparisons). Patients with 1 PS (1PS group) had a higher 60-day survival rate than those with ≥ 2 PS (2+PS group; 96.7 ± 1.1% vs 91.1 ± 3.0%; HR, 2.70; 95% CI, 1.04-7.01; P = .033). The 2+PS group had longer pump time and higher frequency of postoperative dialysis (P.05 for both). Patients with prior VAD had lower 60-day (91.1 ± 3.0% vs 97.1 ± 0.9%; P = .010) and 1-year (87.4 ± 3.6% vs 94.7 ± 1.2%; P = .012) survival rates than NPS group patients. Patients with prior CABG had a lower 1-year survival than NPS group patients (89.0 ± 2.3% vs 94.7 ± 1.2%; P = .018).The PS group had lower 1-year survival and higher intraoperative blood use, postoperative length of ICU and hospital stays, and frequency of reoperation for bleeding than the NPS group. Prior sternotomy increases morbidity and mortality after HTx.

Chagas disease (CD) is becoming an increasingly recognized cause of dilated cardiomyopathy outside of Latin America, where it is endemic, due to population shifts and migration. Heart transplantation (HTx) is a therapeutic option for end-stage cardiomyopathy due to CD, but may be considered a relative contraindication due to potential reactivation of the causative organism with immunosuppression therapy. The total artificial heart (TAH) can provide mechanical circulatory support in decompensated patients with severe biventricular dysfunction until the time of HTx, while avoiding immunosuppressive therapy and removing the organ most affected by the causative organism. We report herein a patient with CD and severe biventricular dysfunction, who had mechanical circulatory support with a TAH for more than 6 months, followed by successful orthotopic HTx and treatment with benznidazole for 3 months. The patient had no evidence of recurrent disease in the transplanted heart based on endomyocardial biopsy up to 1 year post-transplantation, and remains alive more than 30 months after insertion of a TAH and 24 months after HTx.

Introduction. Patients with history of prior sternotomy may have poorer outcomes after heart transplantation. Quantitation of risk from prior sternotomy has not been well established. The United Network for Organ Sharing (UNOS) database was analyzed to assess early and late survival and predictors of outcome in adult heart transplant recipients with and without prior sternotomy. Methods. Of 11,266 adults with first hearteonly transplantation from 1997 to 2011, recipients were divided into 2 groups: those without prior sternotomy (first sternotomy group; n ¼ 6006 or 53.3%) and those with at least 1 prior sternotomy (redo sternotomy group; n ¼ 5260 or 46.7%). A multivariable Cox model was used to identify predictors of mortality. Results. Survival was lower in the redo group at 60 days (92.6% vs 95.9%; hazard ratio [HR] 1.83, 95% confidence interval [CI]: 1.56e2.15; P < .001). Conditional 5-year survival in 60-day survivors was similar in the 2 groups (HR ¼ 1.01, 95% CI 0.90e1.12, P ¼ .90). During the first 60 days post-transplant, the redo group had more cardiac reoperations (12.3% vs 8.8%, P ¼ .0008), a higher frequency of dialysis (8.9% vs 5.2%, P < .0001), a greater percentage of drug-treated infections (23.2% vs 19%, P ¼ .003), and a higher percentage of strokes (2.5% vs 1.4%, P ¼ .0001). A multivariable Cox proportional hazards model identified prior sternotomy as a significant independent predictor of mortality, in addition to age, female gender, congenital cardiomyopathy, need for ventilation, mechanical circulatory support, dialysis prior to transplant, pretransplant serum bilirubin (� 3 mg/dL), and preoperative serum creatinine (� 2 mg/dL). Conclusions. Prior sternotomy is associated with an excess 3.3% mortality and higher morbidity within the first 60 days after heart transplantation, as measured by frequency of dialysis, drug-treated infections, and strokes. Conditional 5-year survival after 60 days is unaffected by prior sternotomy. These findings should be taken into account for risk assessment of patients undergoing heart transplantation.

Aims Mitral annular calcification (MAC) negatively influences outcomes in surgical mitral valve (MV) repair for mitral regurgitation (MR). However, there are no data on whether MAC impacts on outcomes of MitraClip percutaneous MV edge-to-edge repair. This study sought to investigate whether the presence of MAC impacts on the procedural success and durability of percutaneous transcatheter repair of MR using the MitraClip. Methods and results One hundred and seventy-three patients undergoing MitraClip repair for significant MR were studied. Patients with moderate-or-severe MAC (n=28) were compared to those with no-or-mild MAC. Post-procedural MR severity was not different (p=0.642) and MR reduction to moderate-or-less was equally high in patients with moderate-or-severe MAC (100%) and those without (96.7%), p=1.000. At one year, MR severity was not different (p=0.831), and there was no difference in the repair durability when comparing patients with moderate-or-severe MAC (93.8%) to those without (90.6%), p=1.000. All patients with moderate-or-severe MAC assessed at one year were in NYHA functional Class I-II and had haemodynamic improvements with a decrease in pulmonary artery systolic pressure (-6.5±13.1 mmHg), p=0.021, and end-diastolic left ventricular internal diameter (-3.9±6.5 mm), p=0.034, not different to those achieved by patients without MAC (both p>0.100). Conclusions Moderate-or-severe MAC scored by echocardiography and confirmed on fluoroscopy was not associated with decreased procedural success or durability of repair. Patients with moderate-or-severe MAC had improvements in clinical symptoms and haemodynamics, as well as decreased left ventricular dimensions.

ObjectiveThe Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) is a prospective, multicenter, randomized controlled trial comparing percutaneous repair with the MitraClip device to mitral valve (MV) surgery in the treatment of mitral regurgitation. The present study analyzed the patient characteristics and treatment effects on mitral repair versus replacement.MethodsOf 279 patients enrolled, 80 surgical patients underwent 82 MV operations and 178 underwent an initial MitraClip procedure, of whom 37 underwent a subsequent MV operation within 1 year of their index the MitraClip procedure. A logistic regression model was used to predict MV replacement according to valve pathology, etiology of mitral regurgitation, age, previous cardiac surgery, and treatment group.ResultsThe rate of percutaneous or surgical MV repair at 1 year was 89% (158/178) in patients initially receiving the MitraClip device versus 84% (67/80) in the surgical patients (P = .36). Surgical repair was performed after the MitraClip procedure in 20 (54%) of 37patients (P < .001 vs surgery). In both the MitraClip device and surgery groups, MV replacement was significantly associated with anterior leaflet pathology (P = .035). Logistic regression analysis showed that anterior leaflet pathology predicted MV replacement. In 5 (13.5%) of 37 patients undergoing surgery after MitraClip therapy, replacement was performed in part because of MV injury associated with the MitraClip procedure.ConclusionsThese data suggest that anterior leaflet pathology is strongly associated with MV replacement in patients undergoing either de novo MV surgery or surgery after MitraClip therapy. MitraClip therapy has a repair rate similar to surgery through 1 year but also imparts a risk of replacement of a potentially repairable valve.

The role of solid multiorgan transplantation remains to be determined. We compared our experience with combined heart-kidney transplantation (HKT) and heart transplant alone (HT), and assessed patient survival rates and freedom from allograft rejection in these two patient groups.We reviewed the clinical outcomes of patients undergoing HKT (n=30) or HT (n=440) between June 1992 and March 2009. Baseline patient characteristics, perioperative factors, incidence of rejection, and survival were examined.There were no significant differences between the two groups for age, gender, etiology of heart disease, functional class, preoperative left ventricular ejection fraction, end-diastolic diameter, cardiac output, or transplant waitlist status. Patients with HKT had a higher serum creatinine level (P.001) and a greater incidence of hypertension (P=.04). No differences were found in cardiac allograft ischemic times, including cardiopulmonary bypass or cross-clamp times. Kidney allograft ischemic time was 14.6±9 hours (mean±SD; range, 4 hours to 49 hours). Kaplan-Meier survival estimates were similar for the HKT and HT groups at 30 days (93%±4.6% versus 98%±0.7%), 1 year (87%±6.2% versus 93%±1.2%), 5 years (68%±9.0% versus 76%±2.1%), and 10 years (51%±11% versus 53%±3.0%; P=.54 for all comparisons). Follow-up serum creatinine levels were similar after HKT and HT at 30 days (1.6±1.8 mg/dL versus 1.1±0.4 mg/dL), 1 year (1.4±0.6 mg/dL versus 1.5±0.6 mg/dL), and 5 years (1.8±1.8 mg/dL versus 1.8±1.2 mg/dL; P.05 for all comparisons).HKT offers excellent survival and similar renal function when compared with HT alone. Patients with end-stage cardiac and renal failure can be considered for HKT.

Objective Advanced age has been viewed as a contraindication to orthotopic heart transplantation (OHT). We analyzed the outcome of OHT in patients who were aged 70 years or older and compared the results with those in younger patients during a two-decade period. Methods A total of 519 patients underwent first-time single-organ OHT at our institution from 1988 to 2009. Patients were divided into three groups by age: ≥ 70-years old (group 1, n = 37), 60 to 69-years old (group 2, n = 206), and ≤60-years old (group 3, n = 276). Primary endpoints were 30-days, and 1-, 5-, and 10-years survival. Secondary outcomes included re-operation for bleeding, postoperative need for dialysis, and length of postoperative intubation. Results There was no significant difference in survival between the greater than or equal to 70-year-old group and the two younger age groups for the first 10 years after OHT. Survival rates at 30 days, and 1-, 5-, and 10-years, and median survival in group 1 recipients were 100%, 94.6%, 83.2%, 51.7%, and 10.9 years (CI 7.1–11.0), respectively; in group 2 those numbers were 97.6%, 92.7%, 73.8%, 47.7%, and 9.1 years (CI 6.7–10.9), respectively; and in group 3 those numbers were 96.4%, 92.0%, 74.7%, 57.1%, and 12.2 years (CI 10.7–15.4; P = NS), respectively. There was no significant difference in secondary outcomes of re-operation for bleeding, postoperative need for dialysis, and prolonged intubation among the three age groups. Conclusions Patients who are aged 70 years and older can undergo heart transplantation with similar morbidity and mortality when compared with younger recipients. Advanced heart failure patients who are aged 70 years and older should not be excluded from transplant consideration based solely on an age criterion. Stringent patient selection, however, is necessary.

Background The standard biatrial technique for orthotopic heart transplantation uses a large atrial anastomosis to connect the donor and recipient atria. A modified technique involves bicaval and pulmonary venous anastomoses and is believed to preserve the anatomic configuration and physiological function of the atria. Bicaval heart transplantation reduces postoperative valvular regurgitation and is associated with a lower incidence of pacemaker insertion. Objective The aim of this study was to compare postoperative functional capacity and exercise performance in patients with bicaval and biatrial orthotopic heart transplantation. Methods Patients were selected for the study if they did not have any of the following: obstructive coronary artery disease (>50% stenosis), severe mitral or tricuspid regurgitation, signs of rejection (grade ≥1B-1R) on endomyocardial biopsy during the prior year, respiratory impairment, a permanent pacemaker, orthopedic or muscular impediments, or lived more than 150 miles from the medical center. A total of 27 patients qualified. In 15 patients who received a biatrial heart transplant and 12 patients with a bicaval heart transplant, a stationary bicycle exercise test was performed. Ventilatory gas exchange and maximum oxygen consumption measurements were measured. Results Recipient and donor characteristics, including body surface area, donor/recipient weight mismatch, immunosuppressive regimen, and self-reported weekly exercise activity, did not differ between the biatrial and bicaval groups (P = not significant [NS]). At peak exercise, similar heart rate, workload, oxygen consumption, carbon dioxide production, ventilation, functional capacity, and exercise duration were found between the 2 groups (P = NS). Patients in the biatrial group were studied later than patients in the bicaval group (6.54 ± 0.71 vs 4.68 ± 0.28 years; P Conclusion There were no significant differences in the exercise capacity between patients with biatrial versus bicaval techniques for orthotopic heart transplantation. Factors other than the atrial connection (such as cardiac denervation, immunosuppressive drug effect, or physical deconditioning) may be more important determinants of subnormal exercise capacity after heart transplantation. Nevertheless, the reduction in morbidity and postoperative complications and the simplicity in the bicaval technique suggest that bicaval heart transplantation offers advantages when compared with the standard biatrial technique.

ObjectivesThe purpose of this study was to evaluate outcomes of heart transplantation (HTx) and changes in left ventricular wall thickness (LVWT) post-HTx using donors with left ventricular hypertrophy (LVH).BackgroundLimited data are available on use of donor hearts with LVH in HTx.MethodsWe reviewed 427 patients who underwent HTx: 62 received hearts with LVH (interventricular septum [IVS] or posterior wall [PW] thickness ≥1.2 cm) by echocardiography, and 365 received hearts without LVH. The median follow-up was 3.8 years (range 0 to 16.2 years).ResultsRecipient age was 56 ± 11 years and donor age was 30 ± 12 years. Baseline recipient characteristics were similar in both groups. Donors with LVH were older (35 ± 12 years vs. 29 ± 12 years, p = 0.001) and had higher rates of intracranial hemorrhage (38% vs. 15%, p = 0.001). The LVWT was increased in the LVH group compared with LVWT in the non-LVH group (IVS: 1.28 ± 0.18 cm vs. 0.85 ± 0.19 cm, PW: 1.27 ± 0.19 cm vs. 0.85 ± 0.20 cm, p = 0.0001 for both groups). Mild LVH (1.2 to 1.3 cm) was found in 42%, moderate (>1.3 to 1.7 cm) in 53%, and severe (>1.7 cm) in 5% of donors with LVH. Left ventricular wall thickness regression occurred in both IVS and PW (1.28 ± 0.18 cm vs. 1.10 ± 0.13 cm vs. 1.13 ± 0.14 cm, and 1.27 ± 0.19 cm vs. 1.11 ± 0.11 cm vs. 1.13 ± 0.14 cm, at baseline, 1 year, and 5 years, respectively; p < 0.001 for change from baseline to 1 and 5 years for both locations). Patients with or without donor LVH had similar 1-year (3.5% vs. 9.5%, p = 0.2) and 5-year survival rates (84 ± 5.9% vs. 70 ± 2.7%, p = 0.07).ConclusionsShort- and long-term survival rates and rates of LVH at follow-up were similar in both groups, suggesting that donor hearts with mild and moderate LVH can be safely used in HTx.

Background This retrospective study of prospectively collected data compared coronary artery bypass graft (CABG) surgery to drug‐eluting stenting (DES) in diabetic patients with multivessel coronary artery disease (CAD). Prior randomized trials and clinical studies have suggested that CABG may be the preferred revascularization strategy in diabetic patients with multivessel CAD. Data are limited regarding the impact of DES vs. CABG on clinical outcomes. Methods We included 205 consecutive diabetic patients who underwent either CABG ( n =103) or DES ( n =102). The primary clinical end points were freedom from major adverse cardiac events (MACE) at 30 days and 1 year. Results Baseline characteristics were similar between both groups. At 1 year, the mortality rate was similar in the CABG and DES group (8% vs. 10%, p =0.6) but the MACE rate was lower in the CABG group (12% vs. 27%, p =0.006) due to less repeat revascularization with CABG (3% vs. 20%, p p =0.04). Angiographically‐documented stent thrombosis after DES occurred in 3%. Presentation with acute myocardial infarction (hazard ratio [HR], 2.26, 95% CI, 1.13 to 4.55) and DES (HR, 2.4, 95% CI, 1.23 to 4.77) were positive independent predictors, whereas therapy with a statin was a negative independent predictor of MACE (HR, 0.40, 95% CI, 0.21 to 0.76). Conclusions Bypass surgery was associated with less MACE primarily due to the higher repeat revascularization rate with DES and is therefore superior to DES despite more extensive CAD in CABG patients.

In EVEREST II (Endovascular Valve Edge-to-Edge Repair Study), treatment of mitral regurgitation (MR) with a novel percutaneous device showed superior safety compared with surgery, but less effective reduction in MR at 1 year.This study sought to evaluate the final 5-year clinical outcomes and durability of percutaneous mitral valve (MV) repair with the MitraClip device compared with conventional MV surgery.Patients with grade 3+ or 4+ MR were randomly assigned to percutaneous repair with the device or conventional MV surgery in a 2:1 ratio (178:80). Patients prospectively consented to 5 years of follow-up.At 5 years, the rate of the composite endpoint of freedom from death, surgery, or 3+ or 4+ MR in the as-treated population was 44.2% versus 64.3% in the percutaneous repair and surgical groups, respectively (p = 0.01). The difference was driven by increased rates of 3+ to 4+ MR (12.3% vs. 1.8%; p = 0.02) and surgery (27.9% vs. 8.9%; p = 0.003) with percutaneous repair. After percutaneous repair, 78% of surgeries occurred within the first 6 months. Beyond 6 months, rates of surgery and moderate-to-severe MR were comparable between groups. Five-year mortality rates were 20.8% and 26.8% (p = 0.4) for percutaneous repair and surgery, respectively. In multivariable analysis, treatment strategy was not associated with survival.Patients treated with percutaneous repair more commonly required surgery for residual MR during the first year after treatment, but between 1- and 5-year follow-up, comparably low rates of surgery for MV dysfunction with either percutaneous or surgical therapy endorse the durability of MR reduction with both repair techniques. (EVEREST II Pivotal Study High Risk Registry; NCT00209274).

ObjectivesThis study evaluated the clinical outcomes of consecutive, selected patients treated with coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for unprotected left main coronary artery (ULMCA) disease.BackgroundAlthough recent data suggest that PCI with DES provides better clinical outcomes compared to bare-metal stenting for ULMCA disease, there is a paucity of data comparing PCI with DES to CABG.MethodsSince April 2003, when DES first became available at our institution, 123 patients underwent CABG, and 50 patients underwent PCI with DES for ULMCA disease.ResultsHigh-risk patients (Parsonnet score >15) comprised 46% of the CABG group and 64% of the PCI group (p = 0.04). The 30-day major adverse cardiac and cerebrovascular event (MACCE) rate for CABG and PCI was 17% and 2% (p < 0.01), respectively. The mean follow-up was 6.7 ± 6.2 months in the CABG group and 5.6 ± 3.9 months in the PCI group (p = 0.26). The estimated MACCE-free survival at six months and one year was 83% and 75% in the CABG group versus 89% and 83% in the PCI group (p = 0.20). By multivariable Cox regression, Parsonnet score, diabetes, and CABG were independent predictors of MACCE.ConclusionsDespite a higher percentage of high-risk patients, PCI with DES for ULMCA disease was not associated with an increase in immediate or medium-term complications compared with CABG. Our data suggest that a randomized comparison between the two revascularization strategies for ULMCA may be warranted.

In this study we compared the surgical management of ischemic mitral regurgitation (IMR) by revascularization alone and by revascularization combined with mitral valve repair.We studied 355 patients who underwent revascularization alone (n = 168) or revascularization combined with mitral valve repair (n = 187) for IMR from March 1994 to September 2003. Preoperative and operative characteristics, postoperative mitral regurgitation severity, operative mortality, and late survival were examined for each surgical group.No differences were noted between the two groups in age, sex, history of diabetes or hypertension, and number of bypass grafts. The combined surgical group had a lower preoperative left ventricular ejection fraction (0.38 +/- 0.14 versus 0.44 +/- 0.15), greater severity of IMR, higher frequency of prior myocardial infarction, and longer cross-clamp and pump times (p0.01). The combined surgical group had a greater reduction in IMR grade (2.7 +/- 0.1 grades versus 0.2 +/- 0.1 grade), a lower postoperative IMR grade (0.9 +/- 0.1 versus 2.3 +/- 0.1), and a higher success with reduction of IMR by two or more grades (89% versus 11%) (p0.001). In patients with 3+ or 4+ IMR, both groups had similar operative mortality (11.0% in the combined group compared with 4.7% for revascularization alone, p = 0.11) and actuarial survival at 5 years (44% +/- 5% versus 41% +/- 7%, p = 0.53). Independently predictive of higher early mortality (or = 30 days) by Cox analysis were longer pump time (p0.001) and older age (p0.02). Predictive of late mortality (30 days) were older age (p0.001), fewer bypass grafts (p0.01), and lower ejection fraction (p0.01). After adjustment for these variables, there was a trend (p = 0.08) toward a higher late survival with the combined surgical procedure.In patients with IMR, combined mitral valve repair and revascularization resulted in less postoperative mitral regurgitation and similar 5-year survival when compared with revascularization alone. Attempts to reduce pump time by using off-pump techniques may reduce early mortality in these high-risk patients.

Combined heart and kidney transplantation is increasing in frequency but there are no guidelines to establish the indications, contraindications and sequence for this surgical procedure. We report our single-centre experience on 30 consecutive patients who underwent combined heart and kidney transplant in comparison with heart transplant alone. Patients had similar preoperative characteristics in both groups. Combined heart and kidney transplant is associated with the same long-term survival rate, low cellular rejection and antibody-mediated rejection rates when compared with heart transplant alone. We did not observe any difference in the outcomes related to preoperative patient characteristics. We suggest the staged surgical approach as the preferred method for transplant.

The Organ Care System, an ex-vivo heart perfusion platform, represents an alternative to the current standard of cold organ storage that sustains the donor heart in a near-physiologic state. It is unknown whether using the Organ Care System influences 2-year outcomes after heart transplantation. We reviewed our institutional experience to compare 2-year outcomes for patients randomized to the Organ Care System or standard cold storage.Between 2011 and 2013, heart transplant candidates from a single tertiary-care medical center enrolled within the PROCEED II trial were randomized to either standard cold storage or the Organ Care System. Outcomes assessed included 2-year survival, freedom from cardiac allograft vasculopathy (CAV), non-fatal major cardiac events (NF-MACE), biopsy-proven cellular rejection (CMR) and biopsy-proven antibody-mediated rejection (AMR).Thirty-eight patients were randomized to the Organ Care System (n = 19) or cold storage group (n = 19). There was no significant difference in 2-year patient survival (Organ Care System: 72.2%; cold storage: 81.6%; p = 0.38). Similarly, there were no differences in freedom from CAV, NF-MACE, CMR or AMR. The Organ Care System group had significantly longer total ischemia time (361 ± 96 minutes vs 207 ± 50 minutes; p0.001) and shorter cold ischemia time (134 ± 45 minutes vs 207 ± 50 minutes; p0.001) compared with the cold storage group.The Organ Care System did not appear to be associated with significant differences in intermediate results compared with conventional strategies. These results suggest that this ex-vivo allograft perfusion system is a promising and valid platform for donor heart transportation.

Background: Avoiding cardiopulmonary bypass in coronary artery bypass grafting is thought to reduce early mortality and morbidity. Methods: We used our prospective database to compare all patients having off-pump coronary surgery (n = 389) with those having on-pump coronary surgery (n = 2412) between March 15, 1995, and November 1, 2000. Patients were grouped by age (years) in decades (>90, 80-89, 70-79, 60-69

Objective: Limited availability of donor organs has led to the progressive expansion of the criteria for donor selection, particularly a higher age limit of potential donors. We retrospectively reviewed the outcomes of patients who underwent heart transplantation using cardiac allografts 50 years of age and older and compared them with patients who had donor organs younger than 50 years. Method: Between September 1989 and May 2000, 20 patients underwent orthotopic heart transplantation using donor hearts 50 years of age and older (range 50-56 years, mean 52.7 ± 1.8 years) and were compared with 267 patients who received donor organs less than 50 years of age (range 9-49.9 years, mean 27.2 ± 8.6 years). Patient and donor criteria were identical in both groups. Follow-up was 4 to 128 months with a mean of 37.4 ± 2.8 months in the older donor group and 52.6 ± 2.4 months in the younger donor group. Results: There were no differences between these 2 cohorts of patients regarding age, sex, cardiomyopathy, preoperative cytomegalovirus status, New York Heart Association class, and transplant status at transplantation. Donor characteristics, including sex, left ventricular ejection fraction, diabetes, cytomegalovirus status, and allograft ischemic times, were also similar in the 2 groups. Donor/recipient cytomegalovirus matching showed no differences as well. Thirty-day or to discharge operative mortality was similar in the older and younger donor groups (5% ± 4.8% vs 3.5% ± 1.1%; P =.84). Actuarial survival at 1 and 5 years was also similar in both groups (89.7% ± 6.9% vs 91% ± 1.8% and 53.1% ± 14.7% vs 71.0% ± 3.1%, respectively; P =.59). No patient in the older donor group required coronary artery bypass grafting or retransplantation during the follow-up period, whereas 2 patients in the younger donor group required coronary artery bypass, and 5 patients underwent retransplantation ( P ≥.50). Two patients in the older donor group died of nonspecific allograft failure, whereas 3 patients in the younger donor group experienced similar posttransplant complication ( P ≥.50). Conclusions: Carefully selected donor hearts 50 years of age and older can be used for heart transplantation with long-term survival and related outcomes similar to those of younger donor organs. This use of selective cardiac allografts maximizes donor organ usage and expands the donor pool effectively without an adverse impact on long-term results. J Thorac Cardiovasc Surg 2002;123:810-5

With the evolution of transcatheter valve replacement, an important opportunity has arisen for cardiologists and surgeons to collaborate in identifying the criteria for performing these procedures. Therefore, The Society for Cardiovascular Angiography and Interventions (SCAI), American Association for Thoracic Surgery (AATS), American College of Cardiology (ACC), and The Society of Thoracic Surgeons (STS) have partnered to provide recommendations for institutions to assess their potential for instituting and/or maintaining a transcatheter valve program. This article concerns transcatheter pulmonic valve replacement (tPVR). tPVR procedures are in their infancy with few reports available on which to base an expert consensus statement. Therefore, many of these recommendations are based on expert consensus and the few reports available. As the procedures evolve, technology advances, experience grows, and more data accumulate, there will certainly be a need to update this consensus statement. The writing committee and participating societies believe that the recommendations in this report serve as appropriate requisites. In some ways, these recommendations apply to institutions more than to individuals. There is a strong consensus that these new valve therapies are best performed using a Heart Team approach; thus, these credentialing criteria should be applied at the institutional level. Partnering societies used the ACC's policy on relationships with industry (RWI) and other entities to author this document (http://www.acc.org/guidelines/about-guidelines-and-clinical-documents). To avoid actual, potential, or perceived conflicts of interest due to industry relationships or personal interests, all members of the writing committee, as well as peer reviewers of the document, were asked to disclose all current healthcare-related relationships including those existing 12 months before the initiation of the writing effort. A committee of interventional cardiologists and surgeons was formed to include a majority of members with no relevant RWI and to be led by an interventional cardiology cochair and a surgical cochair with no relevant RWI. Authors with relevant RWI were not permitted to draft or vote on text or recommendations pertaining to their RWI. RWI were reviewed on all conference calls and updated as changes occurred. Author and peer reviewer RWI pertinent to this document are disclosed in the Appendices. In addition, to ensure complete transparency, authors' comprehensive disclosure information (including RWI not pertinent to this document) is available in Appendix AII. The work of the writing committee was supported exclusively by the partnering societies without commercial support. SCAI, AATS, ACC, and STS believe that adherence to these recommendations will maximize the chances that these therapies will become a successful part of the armamentarium for treating valvular heart disease in the United States. In addition, these recommendations will hopefully facilitate optimum quality during the delivery of this therapy, which will be important to the development and successful implementation of future, less invasive approaches to structural heart disease.

In obese patients with heart failure, weight reduction may be difficult due to physical restrictions, but may be necessary to achieve heart transplant candidacy. We report the outcomes of obese patients who underwent implantation of a left ventricular assist device (LVAD) using a pulsatile (HeartMate XVE [XVE]) or continuous flow (HeartMate II [HMII]) design and the effect on body mass index (BMI).Of 37 patients with BMI30 kg/m(2) who underwent LVAD implantation, 29 survived at least 30 days and were followed for weight change. In the 30-day survivors, end points of the study were continued LVAD support, heart transplant, or death. One patient underwent gastric bypass surgery and was excluded.In the 28 patients who met inclusion criteria, BMI was 35.6 ± 4.4 kg/m(2) at baseline, and at follow-up was 33.1 ± 5.5 kg/m(2) (mean BMI change -2.5 kg/m(2); P = .063), with a mean follow-up time of 301.6 ± 255.5 days. The XVE group showed a significant BMI reduction of 3.9 kg/m(2) (P = .016 vs baseline); however, the HMII group showed 0.1 kg/m(2) increase in BMI. BMI 30 kg/m(2) at follow-up was achieved in 6 patients (21%), 5 of 19 (26%) in XVE group, and 1 of 9 (11%) in HMII group. In the 14 patients (12 XVE, 2 HMII) or 50% who received a heart transplant, the mean decrease in BMI was 4.6 kg/m(2) (P = .003).LVAD placement in patients with BMI30 kg/m(2) provided significant weight loss in the pulsatile XVE group, but not in recipients of the continuous flow HMII. In patients successfully bridged to a heart transplant after LVAD insertion, mean reduction in BMI was 4.6 kg/m(2) (P = .003). LVAD implantation provides a period of hemodynamic support for obese patients with advanced heart failure, during which time opportunity may be available for weight loss. Pulsatile devices appear to be associated with greater weight loss than nonpulsatile continuous flow devices. Additional therapies may be necessary to achieve significant weight loss in recipients of the continuous flow LVAD.

Background— The endomyocardial biopsy (EMB) is considered the gold standard in rejection surveillance post cardiac transplant, but is invasive, with risk of complications. A previous trial suggested that the gene expression profiling (GEP) blood test was noninferior to EMB between 6 and 60 months post transplant. As most rejections occur in the first 6 months, we conducted a single-center randomized trial of GEP versus EMB starting at 55 days post transplant (when GEP is valid). Methods and Results— Sixty heart transplant patients meeting inclusion criteria were randomized beginning at 55 days post transplant to either GEP or EMB arms. A positive GEP ≥30 between 2 and 6 months, or ≥34 after 6 months, prompted a follow-up biopsy. The primary end point included a composite of death/retransplant, rejection with hemodynamic compromise or graft dysfunction at 18 months post transplant. A coprimary end point included change in first-year maximal intimal thickness by intravascular ultrasound, a recognized surrogate for long-term outcome. Corticosteroid weaning was assessed in both the groups. The composite end point was similar between the GEP and EMB groups (10% versus 17%; log-rank P =0.44). The coprimary end point of first-year intravascular ultrasound change demonstrated no difference in mean maximal intimal thickness (0.35±0.36 versus 0.36±0.26 mm; P =0.944). Steroid weaning was successful in both the groups (91% versus 95%). Conclusions— In this pilot study, GEP starting at 55 days post transplant seems comparable with EMB for rejection surveillance in selected heart transplant patients and does not result in increased adverse outcomes. GEP also seems useful to guide corticosteroid weaning. Larger randomized trials are required to confirm these findings. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00962377.

Preexisting pulmonary hypertension (PH) is associated with poor outcomes after surgical mitral valve repair for functional mitral regurgitation (FMR). However its clinical impact on MitraClip therapy remains unknown. The aim of this study was therefore to evaluate the impact of preexisting PH on MitraClip therapy for patients with FMR. Ninety-one consecutive patients who had FMR and who underwent the MitraClip procedure were studied. They were divided into 2 groups on the basis of pulmonary artery systolic pressure: the PH group (n = 48) and the non-PH group (n = 43). PH was defined as pulmonary artery systolic pressure >50 mm Hg using Doppler echocardiography. Procedural success (defined as magnetic resonance reduction to grade 2+ or less) and 30-day mortality were similar in the 2 groups. At 12 months, New York Heart Association functional class had improved to class I or II in most patients in the PH (from 2.9% to 94.3%) and non-PH (from 9.4% to 96.9%) groups. The mean pulmonary artery systolic pressure of the PH group significantly decreased from baseline but remained higher than that of the non-PH group (50.8 ± 15.3 vs 36.7 ± 11.6 mm Hg, p

The mitral annulus plays an essential role in mitral valve (MV) competency. When surgical intervention is needed, the placement of an annular ring is considered a major component of MV repair. However, the use of a foreign material increases the risk of infectious and thromboembolic complications and is problematic in children as it does not allow for annular growth. Herein is reported a case of infective endocarditis affecting a mitral ring that was implanted to treat severe mitral valve regurgitation (MR) some 10 years earlier. Surgery was performed to remove the MV vegetation, and subsequent echocardiography revealed only trace MR. The concept that the ring may be needed for a limited period of time to induce valve remodeling is consistent with new data on biodegradable rings. These rings degrade over months, inducing dense fibrous tissue that replaces the ring and maintains valve competency. The present case is one of the first human examples to support the potential efficacy of a biodegradable ring.

Objective: We sought to compare outcomes with tissue and St Jude Medical mechanical valves over a 20-year period. Methods: Valve-related events and overall survival were analyzed in 2533 patients 18 years of age or older undergoing initial aortic, mitral, or combined aortic and mitral (double) valve replacement with a tissue valve (Hancock, Carpentier-Edwards porcine, or Carpentier-Edwards pericardial) or a St Jude Medical mechanical valve. Total follow-up was 13,390 patient-years. There were 666 St Jude Medical aortic valve replacements, 723 tissue aortic valve replacements, 513 St Jude Medical mitral valve replacements, 402 tissue mitral valve replacements, 161 St Jude Medical double valve replacements, and 68 tissue double valve replacements. The mean age was 68 ± 13.3 years (St Jude Medical valve, 64.5 ± 12.9; tissue valve, 72.0 ± 12.6). Results: There were no overall differences in survival between tissue and mechanical valves. Multivariable analysis indicated that the type of valve did not affect survival. Analysis by age less than 65 years or 65 years or older and presence or absence of coronary disease revealed similar long-term survival in all subgroups. The risk of hemorrhage was lower in patients receiving tissue aortic valve replacements but was not significantly different in patients receiving mitral valve or double valve replacements. Thromboembolism rates were similar for tissue and mechanical valve recipients. However, reoperation rates were significantly higher in patients receiving both aortic and mitral tissue valves. The reoperation hazard increased progressively with time both in patients receiving aortic and in those receiving mitral tissue valves. Overall valve complications were initially higher with mechanical aortic valves but not with mechanical mitral valves. However, valve complication rates later crossed over, with higher rates in tissue valve recipients after 7 years in patients undergoing mitral valve replacement and 10 years in those undergoing aortic valve replacement. Conclusions: Tissue and mechanical valve recipients have similar survival over 20 years of follow-up. The primary tradeoff is an increased risk of hemorrhage in patients receiving mechanical aortic valve replacements and an increased risk of late reoperation in all patients receiving tissue valve replacements. The risk of tissue valve reoperation increases progressively with time. J Thorac Cardiovasc Surg 2001;122:257-69

Objective: Advanced age has traditionally been considered a contraindication for heart transplantation because of the reported adverse effect of increased age on long-term survival. However, as the field of transplantation continues to evolve, the criteria regarding the recipient's upper age limit have been expanded and older patients are being considered as potential candidates. We analyzed the outcome of heart transplantation in patients 70 years of age and older and compared these results with those in younger patients (

Discussions of the ethics involved in allocating scarce resources often proceed without a grounding in factual experience. This study explored whether there was statistical evidence to support the use of set age limits in patient selection criteria for heart transplantation. Many transplant teams have selection criteria that include age limits, excluding patients more than 60 or 65 years of age from being considered as transplant candidates. The hypothesis was made that patients in the age bracket of 60-69 should have a comparable success rate with transplantation to that of younger recipients when selected by using the same medical and psychiatric criteria. Based on their clinical observations, the authors postulated that the elderly would report better quality of life postoperatively than younger control subjects.

Over the last two decades, the radial artery (RA) has become a routinely used conduit for coronary artery bypass graft surgery. One potential disadvantage of the radial artery is its higher susceptibility to vasospasm compared with other arterial grafts. We investigated whether adventitial dissection of the radial artery can reduce vasoconstriction and increase free blood flow.Following harvesting, the adventitia of the radial artery was dissected using coronary scissors. Surplus distal radial artery segments (n = 35) with and without adventitial dissection of patients undergoing coronary artery bypass surgery were collected and pairwise assessment of vasoreactivity to potassium chloride, U46619 and acetylcholine was performed in organ bath experiments. Free blood flow was measured before and after adventitial dissection.Full curve and maximal vasoconstriction of the RA to potassium chloride (P = 0.015 and 0.001) and U46619 (P = 0.048 and 0.001) was significantly reduced after adventitial dissection compared with non-adventitial dissected radial arteries. Endothelium-dependent relaxation to acetylcholine of adventitial dissected radial arteries was significantly increased (P = 0.006) compared with non-adventitial dissected radial arteries. Maximal vasorelaxation to acetylcholine was significantly increased for adventitial dissected radial arteries compared with non-adventitial dissected radial arteries (P = 0.018). Free blood flow was significantly increased after adventitial dissection (P = 0.037).The adventitial dissected radial artery is less susceptible to vasoconstriction and more prone to vasorelaxation ex vivo and shows an increased free blood flow. Therefore, we suggest adventitial dissection of the radial artery graft to reduce vasospasm for arterial revascularization in coronary artery bypass surgery.

Background The clinical benefits of the left internal thoracic artery–to–left anterior descending coronary artery graft are well established in coronary artery bypass graft surgery ( CABG ). However, limited data are available regarding the long‐term outcome of the radial artery ( RA ) as a secondary conduit over the established standard of the saphenous venous graft. Methods and Results We compared the 12‐year survival outcome in a set of propensity‐matched CABG patients who received either the RA or the saphenous vein as a secondary conduit. A multivariable logistic regression that included 18 baseline characteristics was used to define the propensity of receiving an RA graft. The propensity model resulted in 260 matched pairs who underwent first‐time isolated CABG from 1996 to 2001 with similar preoperative characteristics (C statistic=0.86). The cumulative 12‐year survival estimated by use of the K aplan– M eier method was higher for the RA graft patients (hazard ratio 0.76; P =0.03). This survival advantage was especially significant in diabetics ( P =0.005), in women ( P =0.02), and in the elderly ( P =0.04.) The protective effect appeared beginning at year 5 post surgical intervention. Conclusion The RA as a secondary conduit provided superior long‐term survival after CABG , especially in diabetic patients, women, and the elderly. This effect was most pronounced >5 years after surgery.

Objective: Our objective was to assess survival, need for pacemaker insertion, and rejection frequency with a new surgical technique of orthotopic heart transplantation using bicaval and pulmonary venous anastomoses. Methods: We retrospectively reviewed 100 consecutive patients who had orthotopic heart transplantation with this technique between July 1991 and September 1995. Results: The mean age was 57.0 ± 11.1 years, with 51 patients being 60 years or older. The mean donor/recipient weight ratio was 0.92, and in 28 patients the ratio was less than 0.8. The early (30-day) survival was 100% and the 1- and 2-year survivals were 98% ± 2% and 96% ± 2%, respectively. Survival was not affected by age or by the duration of the OKT3 therapy ( p > 0.2 for each of these parameters). The seven late deaths were due to infection ( n = 2), graft atherosclerosis ( n = 3), acute rejection ( n = 1), and nonspecific graft failure ( n = 1). No permanent pacemaker was required in the first 6 months after the operation, and all the patients were discharged in normal sinus rhythm. Freedom from treated rejection was significantly greater in patients with 7 days of OKT3 therapy than in patients with 14 days of therapy ( p Conclusions: Orthotopic heart transplantation with bicaval and pulmonary venous anastomoses offers an improved alternative to the standard biatrial technique, with a 30-day mortality of 0% in 100 consecutive patients, excellent intermediate-term survival, and elimination of the need for pacemaker insertion. More normal anatomic configuration and synchronous function of the atria may have contributed to these results. (J T horac C ardiovasc S urg 1996;112:1496-503)

The efficacy of antithymocyte globulin (ATG) induction in the therapy of immunologically low- and high-risk patients after heart transplantation is not known.All patients who received ATG induction from January 2000 through January 2010 were divided into two groups based on the risk of rejection. A higher-risk group (age younger than 60 years, multiparous females, African Americans, panel-reactive antibody10%, or positive cross-match) received ATG (1.5 mg/kg) for 7 days (ATG7), and the remaining lower-risk group received ATG for 5 days (ATG5), all followed by calcineurin inhibitor, mycophenolate, and prednisone. Endomyocardial biopsies were performed based a standard protocol for up to 3 years after heart transplantation, and for suspected rejection.Of 253 heart transplant recipients, 87 received ATG5 and 166 ATG7. Absolute lymphocyte count 200 per microliter was achieved within 10 days in 88% of ATG5 and 86% of ATG7. Baseline creatinine was 1.3 ± 0.8 pre-transplantation, 1.8 ± 0.9 post-transplantation, and 1.0 ± 0.4 mg/dL at discharge (mean ± standard deviation [SD]; P .001, compared with pre-transplantation). Of 3667 biopsies, 33 (0.90%) had ≥3A/2R cellular rejection (CR). Of 3599 biopsies, 16 (0.44%) had definite antibody-mediated rejection (AMR). At 5 years, freedom from ≥3A/2R CR (94% ± 2.8% vs 83% ± 7.7%; P = .31) and freedom from AMR (95% ± 2.4% vs 90% ± 6.4%; P = .98) were similar between ATG5 and ATG7, respectively. Survival for ATG5 and ATG7 was comparable at one year (94% ± 2.5% vs 93% ± 2.0%), and at 8 years (61% ± 6.9% and 61% ± 4.7%; P = .88). At 5 years, ATG5 and ATG7 were similar in freedom from cytomegalovirus (CMV) infection (92.3% vs 94.3%; P = not significant [NS]), freedom from pneumonia (83.8% vs 82.1%; P = NS), and in rate of malignancy (excluding skin cancer; 8.0% vs 6.0%; P = NS).ATG induction therapy (prospectively dose-adjusted for immunologic risk) in low- and high-risk patients results in excellent and equivalent short- and long-term survival rates, with a low incidence of CR and AMR. The use of ATG does not increase rates of CMV infection with appropriate prophylaxis. ATG may benefit renal function by delaying calcineurin inhibitor exposure, and may have a role in the prevention of AMR.

Background Ventricular assist device (VAD) implantation as a bridge to cardiac transplantation is an effective treatment option for end-stage heart failure. Renal dysfunction is not uncommon but is considered to be a poor prognostic factor. We present our experience with 6 patients who had combined heart and kidney transplantation (HKT) after VAD implantation for advanced cardiac and renal failure. Methods Of 74 patients who underwent VAD implantation as a bridge to transplant from May 2001 to September 2009, 28 patients developed renal failure, and of these, 6 (5 male, 1 female, ages 40–64 years) had HKT. All required hemodialysis because of renal failure before HKT. Immunosuppression consisted of anti-thymocyte globulin followed by triple drug therapy consisting of calcineurin inhibitors, mycophenolate, and corticosteroids. Results Of the 6 HKT patients, 5 (83%) were alive without hemodialysis at 1 and 2 years; of the 22 patients with renal failure after VAD implantation without subsequent transplant, 1- and 2-year survivals were zero. Interval from VAD implantation to HKT ranged from 36 to 366 days (133 ± 127 days). At 6 months after HKT (100% alive), left ventricular ejection fraction was 60.2 ± 5.8% and serum creatinine 1.1 ± 0.2 mg/dL. Three HKT patients required temporary hemodialysis after surgery. Endomyocardial biopsy showed absence of ISHLT grade 2R-3A or greater cellular rejection, and none showed evidence of definite antibody-mediated rejection. Conclusions Based on our initial experience, simultaneous HKT is a safe treatment option with excellent outcomes for patients with advanced heart failure and persistent renal dysfunction after VAD implantation.

PREAMBLE The granting of staff privileges to physicians is an important mechanism to ensure quality care. The Joint Commission on Accreditation of Healthcare Organizations requires that medical staff privileges be based on professional criteria specified in medical staff bylaws. Physicians are charged with defining the criteria that constitute professional competence and with evaluating their peers accordingly. With the evolution of transcatheter aortic valve replacement (TAVR), an important opportunity arises for both cardiologists and surgeons to come together to identify the criteria for performing these procedures. The Society for Cardiovascular Angiography and Interventions (SCAI), American Association for Thoracic Surgery (AATS), American College of Cardiology Foundation (ACCF), and the Society of Thoracic Surgeons (STS) have, therefore, joined together to provide recommendations for institutions to assess their potential for instituting and/or maintaining a transcatheter valve program. This article concerns TAVR. As TAVR is in its infancy, there are few data on which to base this consensus statement. Therefore, many of these recommendations are based on expert consensus. As the procedures