Prediabetic Patient Outcomes 8 to 15 Years After Drug-Eluting Coronary Stenting.

Guidelines suggest differential management of diabetics and nondiabetics with coronary artery disease (CAD) referred for revascularization, but pre-diabetics, who now comprise up to 20% to 30% of CAD patients, have been excluded from the diabetic group. To address this, we studied long-term cardiac outcomes in 1,323 consecutively drug-eluting stent (DES)-stented patients from prespecified local zip codes, dividing patients into normal-glycemic patients, prediabetics and diabetics, based upon conventional definitions. Patient age was 63±11 years, 65.5% male, mean baseline SYNTAX score of 10.2±6.8 and residual SYNTAX score=3.0±4.6. Only 2.9% of patients were lost to follow up at 10 years. Duration of follow up for alive patients was 124±33 mos. Major adverse cardiac events (MACE) by Kaplan Meier (KM) was similar for normal glycemics and prediabetics (42.9±2.5% vs 38.6±3.1% at 10 years, p=0.35), whereas that for diabetics was worse (56.7±2.6% at 10 years, p<0.001 vs prediabetics). KM cardiac death rates at 10 years were 14.2±1.8%, 16.0±2.4% and 31.2±2.3% for normal glycemics, prediabetics, and diabetics, respectively (p=0.34 and p<0.001 [covariate adjusted p=0.018] for prediabetics versus normal glycemics and versus diabetics, respectively). We found that prediabetics have long-term post-DES outcomes far more similar to those of normal-glycemic patients than diabetics.

Comparison of Long-Term Clinical Outcomes After Drug-Eluting Stenting in Blacks-vs-Whites.

Patients of different racial backgrounds may have socioeconomic, cultural, or genetic differences that impact outcomes after percutaneous coronary intervention (PCI). There are limited data beyond 2 to 3 years for Blacks to inform discussions and perhaps improve outcomes. We studied consecutive limus-stent treated patients, having their first PCI at our institution January 2003 to March 2010 in 2 cohorts; Cohort 1: standard 3-year follow-up (n = 3,782, 12.4% Blacks) and Cohort 2: from nearby zip codes with intended detailed follow-up through 8 to 13 years (n = 616, 31.8% Blacks). The primary outcomes of interest were mortality and death/MI/revascularization (DMIR) (Cohort 1) or major adverse cardiac events (cardiac DMIR) (Cohort 2). In all cohorts, Blacks had a higher prevalence of many risk factors. In Cohort 1, 3-year mortalities were 14.6% and 9.6% (p = 0.001) and DMIR were 32.1% and 25.0% (p = 0.001), for Blacks and Whites, respectively. In Cohort 2, over 9.5 ± 2.0 years, treatment intensity was as high or higher for Blacks, but they continued to have higher low-density lipoprotein-cholesterol and blood pressure values. Major adverse cardiac events and mortality at 10 years were higher for Blacks (59.0% vs 48.1%, p = 0.024 and 44.3% vs 23.0%, p < 0.001). Differences in outcomes, except 10 year mortality, were not significantly different after adjustment for baseline characteristics. Blacks have a higher risk profile at the time of PCI and worse long-term outcomes after drug-eluting stent, most of which is explained by baseline differences.

Long-term results after robotically assisted coronary bypass surgery.

BACKGROUND: Robotically-assisted coronary bypass grafting (CABG) was introduced in 1998 and dedicated centers have continuously applied and developed this minimally invasive method of coronary bypass surgery. While short-term results are relatively well published, data on long-term outcome are limited. In this literature review, we assessed the outcomes after robotic CABG following the first postoperative year. METHODS: We searched PubMed for articles containing the terms "robotic" or "robotically assisted" and "coronary bypass". A total of 11 papers contained long-term results. We specifically investigated survival, graft patency, freedom from angina and re-intervention, as well as freedom from major adverse cardiac and cerebrovascular events (MACCE). RESULTS: Five-year survival after robotic CABG was consistently consistently greater than 90% and graft patency between 3 and 5 years was reported to be above 90%. Fifteen percent to 26% of patients re-experienced angina at 3 to 5 years postoperatively. Long-term freedom from re-intervention reached the range and the 5-year freedom from MACCE rate was approximately 75%. CONCLUSIONS: According to data in the literature, long-term results after CABG carried out with the assistance of a surgical robot appear to be in line with results achieved after conventional CABG.

Coronary atheroma progression rates in men and women following high-intensity statin therapy: A pooled analysis of REVERSAL, ASTEROID and SATURN.

BACKGROUND AND AIMS: High-intensity statin therapy (HIST) reduces cardiovascular events, however, sex-related differences in treatment effects are not well characterized. METHODS: A patient-level post hoc pooled analysis of 3 randomized trials utilizing serial coronary intravascular ultrasound was undertaken, testing the anti-atherosclerotic effects of HIST in coronary disease patients. Sex-related differences in changes (Δ) in coronary percent atheroma volume (PAV) were ascertained following 18-24 months of HIST (atorvastatin 80 mg or rosuvastatin 40 mg daily), and further characterized according to on-treatment lipid and lipoprotein levels. RESULTS: In women (n = 451) compared with men (n = 1190), on-treatment levels of LDL-C (68 ± 24 vs. 67 ± 22 mg/dl, p=0.62) and apoB (77 ± 23 vs. 76 ± 20 mg/dL, p=0.51) were similar; levels of HDL-C (53 ± 12 vs. 47 ± 11 mg/dl, p < 0.001), apoA1 (154 ± 26 vs. 140 ± 24 mg/dl, p < 0.001), triglycerides [122 (95, 158) vs. 114 (89, 154) mg/dl, p=0.012] and CRP [1.7 (0.9, 3.8) vs. 1.1 (0.6, 2.7) mg/l, p < 0.001] were higher; while the total cholesterol/HDL-C (TC/HDL-C) ratio was lower (2.9 ± 0.8 vs. 3.1 ± 0.8, p < 0.001). Compared with men, women harbored significantly lower baseline PAV (34.8 ± 8.7 vs. 38.3 ± 8.8%, p < 0.001), yet demonstrated significantly greater PAV regression (ΔPAV -1.07 ± 0.26 vs. -0.66 ± 0.23%, p=0.02). When achieved on-treatment levels of LDL-C were <64 mg/dl, apoB <73 mg/dl, non-HDL-C <88.8 mg/dl, and TC/HDL-C <2.99, women demonstrated significantly greater PAV regression than men. Multivariable analysis revealed female sex to independently associate with PAV regression (coefficient -0.66, p=0.02). CONCLUSIONS: Women demonstrate greater degrees of coronary plaque regression compared with men following long-term HIST, especially in the setting of lower achieved atherogenic lipoprotein levels.

Outcomes in Patients With Transcatheter Aortic Valve Replacement and Left Main Stenting: The TAVR-LM Registry.

BACKGROUND: A percutaneous approach with transcatheter aortic valve replacement (TAVR) and percutaneous coronary intervention (PCI) of the left main coronary artery (LM) is frequently used in high-risk patients with coexisting aortic stenosis and LM disease. Outcomes of TAVR plus LM PCI have not been previously reported. OBJECTIVES: The primary objective of the TAVR-LM registry is to evaluate clinical outcomes in patients undergoing TAVR plus LM PCI. METHODS: Clinical, echocardiographic, computed tomographic, and angiographic characteristics were retrospectively collected in 204 patients undergoing TAVR plus LM PCI. In total, 128 matched patient pairs were generated by performing 1:1 case-control matching between 167 patients with pre-existing LM stents undergoing TAVR and 1,188 control patients undergoing TAVR without LM revascularization. RESULTS: One-year mortality (9.4% vs. 10.2%, p = 0.83) was similar between the TAVR plus LM PCI cohort and matched controls. One-year mortality after TAVR plus LM PCI was not different in patients with unprotected compared with protected LMs (7.8% vs. 8.1%, p = 0.88), those undergoing LM PCI within 3 months compared with those with LM PCI greater than 3 months before TAVR (7.4% vs. 8.6%, p = 0.61), and those with ostial versus nonostial LM stents (10.3% vs. 15.6%, p = 0.20). Unplanned LM PCI performed because of TAVR-related coronary complication, compared with planned LM PCI performed for pre-existing LM disease, resulted in increased 30-day (15.8% vs. 3.4%, p = 0.013) and 1-year (21.1% vs. 8.0%, p = 0.071) mortality. CONCLUSIONS: Despite the anatomic proximity of the aortic annulus to the LM, TAVR plus LM PCI is safe and technically feasible, with short- and intermediate-term clinical outcomes comparable with those in patients undergoing TAVR alone. These results suggest that TAVR plus LM PCI is a reasonable option for patients who are at high risk for surgery.

A systematic review on the safety of second-generation transcatheter aortic valves.

AIMS: To review the outcomes of studies and the safety of newer transcatheter aortic valves (THV). METHODS AND RESULTS: All studies reporting on second-generation THV were identified and pooled using the systematic review guidelines. Twenty-four reports on 1,708 patients and eight THV were included in the analysis. The pooled 30-day event rate for mortality after transcatheter aortic valve implantation (TAVI) was 5.7% (95% CI: 4.0-7.8), myocardial infarction (MI) was 1.7% (95% CI: 1.1-2.6), stage 3 acute kidney injury (AKI) was 3.4% (95% CI: 2.0-5.6), life-threatening bleeding was 5.1% (95% CI: 3.3-7.8), major vascular complications was 4.9% (95% CI: 3.5-6.6%), major bleeding was 10.5% (95% CI: 5.1-20.4), major stroke was 2.4% (95% CI: 1.7-3.4), permanent pacemaker utilisation was 13.5% (95% CI: 10.8-16.9), and coronary obstruction was 1.2% (95% CI: 0.6%-2.4%). Moderate or severe aortic insufficiency (AI) after TAVI was 4.2% (95% CI: 2.0-8.5). The pooled 30-day mean gradient and effective orifice area (EOA) were 11.63 mmHg (95% CI: 10.19-13.07) and 1.60 cm2 (95% CI: 1.5-1.7), respectively. All estimates compare favourably to events reported for first-generation valves. CONCLUSIONS: Our findings suggest that the new THV have a low risk of TAVI-related short-term complications.

Aborted sternotomy due to unexpected porcelain aorta: does transcatheter aortic valve replacement offer an alternative choice?

OBJECTIVES: Surgical aortic valve replacement is challenging in patients with severe aortic calcification. Some patients undergo sternotomy and have the operation aborted because of intraoperative discovery of severe calcification. Hypothermic circulatory arrest and transcatheter aortic valve replacement offer clampless treatment options for aortic stenosis. The study objectives are to characterize patients who are referred after sternotomy was aborted for porcelain aorta and to describe the treatment outcomes. METHODS: From 2001 to 2013, 19 patients presented after attempt at surgical aortic valve replacement was aborted because of porcelain aorta. Patients presented with aortic stenosis (n = 16), regurgitation (n = 1), or both (n = 2). Off-pump coronary bypass was performed in 10 patients. At the Cleveland Clinic, patients underwent surgical aortic valve replacement (n = 7) or transcatheter aortic valvve replacement (n = 12). The median interval between aborted aortic valve replacement and definitive treatment was 9.6 months. The mean age was 74 ± 11 years. The mean transvalvular gradient was 51 ± 18 mm Hg, and area was 0.6 cm(2). Axillary cannulation was used in all patients undergoing surgical aortic valve replacement, but only 4 required circulatory arrest. The transcatheter aortic valve replacement approach was transfemoral (n = 5), transapical (n = 6), or transaortic (n = 1). RESULTS: The mean postoperative gradient was 13 ± 4 mm Hg. There was no mortality, stroke, renal failure, or reoperation for bleeding. One patient required a second valve implantation for paravalvular leak. The median hospital length of stay was 8 days. Five late noncardiac deaths occurred at a median follow-up of 16 months. CONCLUSIONS: Both surgical aortic valve replacement and transcatheter aortic valve replacement are safe and effective options after aborted sternotomy in patients with porcelain aorta who are referred to a high-risk valve center. Procedure selection may be tailored to individual patients on the basis of aortic morphology and comorbidities. Patients with aortic stenosis at risk for calcific aortic disease should be screened with cross-sectional imaging preoperatively.

Transcatheter aortic valve replacement: experience with the transapical approach, alternate access sites, and concomitant cardiac repairs.

OBJECTIVES: Transapical transcatheter aortic valve replacement (TA-TAVR) is a viable treatment option for selected high-risk elderly patients. We analyzed the 30-day mortality and perioperative complications, focusing on the "learning curve" since our first TA procedure in 2007. We also introduce unique cases, demonstrating new possibilities for alternate access sites and concurrent cardiac interventions using the apical approach. METHODS: From February 2007 to May 2013, 150 patients underwent TA-TAVR (mean age, 81.4 ± 7 years; mean Society of Thoracic Surgeons score, 9.8±3.5). We compared 2 groups (group A, n=65, procedures from February 2007 to December 2010; group B, n=85, procedures from January 2011 to May 2013). RESULTS: Five deaths (3.3%) occurred within 30 days, with a decrease in 30-day mortality between the 2 groups (group A, n=4, 6.2%; group B, n=1, 1.2%) that became significant at 1 year (log-rank, P=.002). Severe bleeding from the apex (group A, 4.6%; group B 4.4%) and deployment of >1 valve (group A, 7.6%; group B, 10.5%) was similar in both groups. Valve embolization was less frequent in group B (group A, 4.6%; group B, 2.4%). Postoperative complications in groups A and B included stroke (3.1% vs 0%), renal failure (9.3% vs 4.7%), and permanent pacemaker implantation (6.1% vs 5.9%). No myocardial infarctions occurred in either group. Two patients received simultaneous aortic and mitral valve implantation; 1 patient undergoing TA-TAVR also underwent distal arch and descending aorta repair; all had favorable outcomes. With a further 25 TA-TAVR since May 2013, the overall mortality is 2.9% (5/175). CONCLUSIONS: Although working with the fragile apical tissues in high-risk elderly patients remains a challenge, we have demonstrated a reduction in mortality and complications with increasing experience in TA-TAVR. We have successfully demonstrated novel combined procedures and uses for the transapical approach and alternate access sites, which should continue to be explored.

Emergency use of cardiopulmonary bypass in complicated transcatheter aortic valve replacement: importance of a heart team approach.

OBJECTIVES: Transcatheter aortic valve replacement (TAVR) expands options for high-risk patients with aortic stenosis but is complex with life-threatening complications. We describe indications for use of salvage cardiopulmonary bypass (CPB) and assess outcomes. METHODS: From 2006 to 2011, 303 patients underwent TAVR, and 12 (4%) required emergency CPB. Approach was transapical (9) and transfemoral (3). Mean age was 82±9 years, median Society of Thoracic Surgeons score was 11 and mean gradient was 46±9 mm Hg. Access for CPB was femoral under fluoroscopy. Principal indication for CPB was hemodynamic instability with or without ischemic changes. These resulted from aortic insufficiency (n=5), valve embolization (n=3), coronary malperfusion (n=2), bleeding requiring pericardiocentesis (n=1), and bleeding from ventricular apex (n=1). Additional procedures included valve-in-valve TAVR (n=5), surgical valve replacement (n=3), and coronary intervention (n=2). Additional circulatory support was used in 7 cases: intra-aortic balloon pump (5) and extracorporeal membrane oxygenation (3). RESULTS: There were 2 hospital deaths. Mean postoperative gradient was 12±9 mm Hg, and median stay was 16 days. There were no myocardial infarctions or renal failure. One patient had stroke with arm weakness, 2 required tracheostomy, and 2 underwent reoperations for bleeding. Median follow-up was 19 months, and there were 5 late deaths. CONCLUSIONS: Complications during TAVR can be life threatening and may necessitate additional procedures. Expeditious use of CPB support provided by a multidisciplinary heart team optimizes rescue after myocardial collapse.

Significance of aortic valve calcification in patients with low-gradient low-flow aortic stenosis.

BACKGROUND: Assessment of patients with aortic stenosis (AS) and impaired left ventricular function remains challenging. Aortic valve calcium (AVC) scoring with computed tomography (CT) and fluoroscopy has been proposed as means of diagnosing and predicting outcomes in patients with severe AS. HYPOTHESIS: Severity of aortic valve calcification correlates with the diagnosis of true severe AS and outcomes in patients with low-gradient low-flow AS. METHODS: Echocardiography and CT database records from January 1, 2000 to September 26, 2009 were reviewed. Patients with aortic valve area (AVA)<1.0 cm2 who had ejection fraction (EF)≤25% and mean valvular gradient≤25 mmHg with concurrent noncontrast CT scans were included. AVC was evaluated using CT and fluoroscopy. Mortality and aortic valve replacement (AVR) were established using the Social Security Death Index and medical records. The role of surgery in outcomes was evaluated. RESULTS: Fifty-one patients who met the above criteria were included. Mean age was 75.1±9.6 years, and 15 patients were female. Mean EF was 21%±4.6% with AVA of 0.7±0.1 cm2. The peak and mean gradients were 35.5±10.6 and 19.0±5.1 mmHg, respectively. Median aortic valve calcium score was 2027 Agatston units. Mean follow-up was 908 days. Patients with calcium scores above the median value were found to have increased mortality (P=0.02). The benefit of surgery on survival was more pronounced in patients with higher valvular scores (P=0.001). Fluoroscopy scoring led to similar findings, where increased AVC predicted worse outcomes (P=0.04). CONCLUSIONS: In patients with low-gradient low-flow AS, higher valvular calcium score predicts worse long-term mortality. AVR is associated with improved survival in patients with higher valve scores.

Left main coronary artery stenosis: a meta-analysis of drug-eluting stents versus coronary artery bypass grafting.

OBJECTIVES: The goal of this study was to provide a systematic review comparing the long-term outcomes of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) versus coronary artery bypass graft surgery (CABG) for unprotected left main coronary artery (UPLM) stenosis. BACKGROUND: One-year outcomes from randomized controlled trials, observational studies, and pooled analyses have demonstrated the safety and efficacy of PCI of the UPLM when compared with CABG. However, there remain concerns over the sustainability of PCI with DES at longer follow-up. METHODS: Studies published between January 2000 and December 2012 of PCI versus CABG for UPLM stenosis were identified using an electronic search and reviewed using meta-analytical techniques. RESULTS: Twenty-four studies comprising 14,203 patients were included in the analysis. There was no significant difference for all-cause mortality between PCI or CABG at 1 year (odds ratio [OR]: 0.792, 95% confidence interval [CI]: 0.53 to 1.19), 2 years (OR: 0.920, 95% CI: 0.67 to 1.26), 3 years (OR: 0.94, 95% CI: 0.60 to 1.48), 4 years (OR: 0.84, 95% CI: 0.53 to 1.33), and 5 years (OR: 0.79, 95% CI: 0.57 to 1.08). The need for target vessel revascularization (TVR) was significantly higher in patients undergoing PCI at all time points. The occurrence of stroke, however, was significantly less frequent in patients treated with PCI. The occurrence of nonfatal myocardial infarction showed a statistically significant trend towards a lower incidence in CABG patients at 1 year (OR: 1.62, 95% CI: 1.05 to 2.50), 2 years (OR: 1.60, 95% CI: 1.09 to 2.35), and 3 years (OR: 2.06, 95% CI: 1.36 to 3.1). There was no significant difference in combined major adverse cardiovascular and cerebrovascular events between the 2 groups. CONCLUSIONS: Our findings suggest that PCI with DES is a safe and durable alternative to CABG for the revascularization of UPLM stenosis in select patients at long-term follow-up.

Concomitant percutaneous coronary intervention and transcatheter aortic valve replacement: safe and feasible replacement alternative approaches in high-risk patients with severe aortic stenosis and coronary artery disease.

OBJECTIVE: Transcatheter aortic valve replacement (TAVR) is performed as a stand-alone procedure in patients that are not suitable for surgical aortic valve replacement. However, a significant proportion of patients with severe aortic stenosis have coexisting coronary artery disease (CAD). We report concomitant TAVR and percutaneous coronary intervention (PCI) as a single procedure in such patients. METHODS: Three patients with severe aortic stenosis and CAD that were high risk for conventional surgery had concomitant alternative approach TAVR and PCI performed. Two patients had PCI and stent placement immediately after the deployment of the transapical transcatheter aortic valve, and one patient had a coronary artery stent placed just prior to the deployment of the transaortic transcatheter aortic valve. RESULTS: Two male patients and one female (age range 68-91 years) had 100% procedural success with resolution of symptoms and zero residual stenosis. There were no complications related to neurologic events, worsening renal function, or myocardial infarction. In-hospital and 30-day mortality was zero. All three patients were discharged home with a median hospital stay of eight days. CONCLUSIONS: In our small series of patients presented we demonstrate that PCI and TAVR performed concurrently in the hybrid operating room is a feasible option in patients undergoing TAVR with coexisting CAD. Furthermore, we propose this single-stage approach in such high-risk patients as it decreases the number of procedures performed and may theoretically lower cost and hospital stay.

A comprehensive review of the PARTNER trial.

OBJECTIVE: Percutaneous transcatheter aortic valve replacement was introduced in 2002, but its effectiveness remained to be assessed. METHODS: A prospective, randomized trial (the Placement of Aortic Transcatheter Valves, or PARTNER) was designed with 2 arms: PARTNER A (n = 699) for high-risk surgical patients (Society of Thoracic Surgeons score >10%, surgeon assessed risk of mortality >15%) and PARTNER B (n = 358, patients inoperable by assessment of 2 surgeons). PARTNER A patients were divided into femoral artery access transcatheter aortic valve replacement or none (n = 207), and then randomized to open aortic valve replacement (n = 351) or device (n = 348). Inclusion criteria included valve area <0.8 cm(2), gradient >40 mm Hg or peak >64 mm Hg, and survival >1 year. The end point of the study was 1-year mortality. RESULTS: Thirty-day mortality for PARTNER A was 3.4% for transcatheter aortic valve replacement and 6.5% for aortic valve replacement; 1-year mortality was 24.2% and 26.8%, respectively (P = .001 for noninferiority). The respective prevalence of stroke was 3.8% and 2.1% (P = .2), although for all neurologic events, the difference between transcatheter aortic valve replacement and aortic valve replacement was significant (P = .04), including 4.6% for femoral artery access transcatheter aortic valve replacement versus 1.4% for open aortic valve replacement (P = .05). For PARTNER B--transcatheter aortic valve replacement versus medical treatment-30-day mortality was 5.0% versus 2.8% (P = .41), and at 1 year, mortality was 30.7% versus 50.7% (P < .001), respectively. Hospitalization cost of transcatheter aortic valve replacement for PARTNER B was $78,542, or $50,200 per year of life gained. Analysis of PARTNER A strokes showed that hazard with transcatheter aortic valve replacement peaked early, but thereafter remained constant in relation to aortic valve replacement. Two-year PARTNER A data showed paravalvular regurgitation was associated with increased mortality, even when mild (P < .001). Continued access to transapical transcatheter aortic valve replacement (n = 853) showed a mortality of 8.2% and decline in strokes to 2.0%. Of the 1801 Cleveland Clinic patients reviewed to December 2010, 214 (12%) underwent transcatheter aortic valve replacement with a mortality of 1%; in 2011, 105 underwent transcatheter aortic valve replacement: 34 transapical aortic valve replacement, with no deaths, and 71 femoral artery access aortic valve replacement with 1 death. CONCLUSIONS: The PARTNER A and B trials showed that survival has been remarkably good, but stroke and perivalvular leakage require further device development.

A practical guide to multimodality imaging of transcatheter aortic valve replacement.

The advent of transcatheter aortic valve replacement (TAVR) is one of the most widely anticipated advances in the care of patients with severe aortic stenosis. This procedure is unique in many ways, one of which is the need for a multimodality imaging team-based approach throughout the continuum of the care of TAVR patients. Pre-procedural planning, intra-procedural implantation optimization, and long-term follow-up of patients undergoing TAVR require the expert use of various imaging modalities, each of which has its own strengths and limitations. Divided into 3 sections (pre-procedural, intraprocedural, and long-term follow-up), this review offers a single source for expert opinion and evidence-based guidance on how to incorporate the various modalities at each step in the care of a TAVR patient. Although much has been learned in the short span of time since TAVR was introduced, recommendations are offered for clinically relevant research that will lead to refinement of best practice strategies for incorporating multimodality imaging into TAVR patient care.

Transcatheter aortic-valve replacement for inoperable severe aortic stenosis.

BACKGROUND: Transcatheter aortic-valve replacement (TAVR) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The outcomes beyond 1 year in such patients are not known. METHODS: We randomly assigned patients to transfemoral TAVR or to standard therapy (which often included balloon aortic valvuloplasty). Data on 2-year outcomes were analyzed. RESULTS: A total of 358 patients underwent randomization at 21 centers. The rates of death at 2 years were 43.3% in the TAVR group and 68.0% in the standard-therapy group (P<0.001), and the corresponding rates of cardiac death were 31.0% and 62.4% (P<0.001). The survival advantage associated with TAVR that was seen at 1 year remained significant among patients who survived beyond the first year (hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.92; P=0.02 with the use of the log-rank test). The rate of stroke was higher after TAVR than with standard therapy (13.8% vs. 5.5%, P=0.01), owing, in the first 30 days, to the occurrence of more ischemic events in the TAVR group (6.7% vs. 1.7%, P=0.02) and, beyond 30 days, to the occurrence of more hemorrhagic strokes in the TAVR group (2.2% vs. 0.6%, P=0.16). At 2 years, the rate of rehospitalization was 35.0% in the TAVR group and 72.5% in the standard-therapy group (P<0.001). TAVR, as compared with standard therapy, was also associated with improved functional status (P<0.001). The data suggest that the mortality benefit after TAVR may be limited to patients who do not have extensive coexisting conditions. Echocardiographic analysis showed a sustained increase in aortic-valve area and a decrease in aortic-valve gradient, with no worsening of paravalvular aortic regurgitation. CONCLUSIONS: Among appropriately selected patients with severe aortic stenosis who were not suitable candidates for surgery, TAVR reduced the rates of death and hospitalization, with a decrease in symptoms and an improvement in valve hemodynamics that were sustained at 2 years of follow-up. The presence of extensive coexisting conditions may attenuate the survival benefit of TAVR. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).

Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study.

OBJECTIVES: The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study (HRS) assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, California) in patients with significant mitral regurgitation (MR) at high risk of surgical mortality rate. BACKGROUND: Patients with severe MR (3 to 4+) at high risk of surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR. METHODS: Patients with severe symptomatic MR and an estimated surgical mortality rate of ≥12% were enrolled. A comparator group of patients screened concurrently but not enrolled were identified retrospectively and consented to compare survival in patients treated by standard care. RESULTS: Seventy-eight patients underwent the MitraClip procedure. Their mean age was 77 years, >50% had previous cardiac surgery, and 46 had functional MR and 32 degenerative MR. MitraClip devices were successfully placed in 96% of patients. Protocol-predicted surgical mortality rate in the HRS and concurrent comparator group was 18.2% and 17.4%, respectively, and Society of Thoracic Surgeons calculator estimated mortality rate was 14.2% and 14.9%, respectively. The 30-day procedure-related mortality rate was 7.7% in the HRS and 8.3% in the comparator group (p = NS). The 12-month survival rate was 76% in the HRS and 55% in the concurrent comparator group (p = 0.047). In surviving patients with matched baseline and 12-month data, 78% had an MR grade of ≤2+. Left ventricular end-diastolic volume improved from 172 ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p = 0.001). New York Heart Association functional class improved from III/IV at baseline in 89% to class I/II in 74% (p < 0.0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 [p = 0.014] and the mental component score from 45.5 to 48.7 [p = 0.065]) at 12 months. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32 (p = 0.034). CONCLUSIONS: The MitraClip device reduced MR in a majority of patients deemed at high risk of surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months. (Pivotal Study of a Percutaneous Mitral Valve Repair System [EVEREST II]; NCT00209274).