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The elderly population is the fastest growing demographic in Western countries. As the population ages, the incidence of age-related comorbidities such as diabetes mellitus, chronic obstructive pulmonary disease, peripheral vascular disease, renal disease, cerebrovascular disease, and cardiovascular disease increases. With cardiovascular disease occurring in approximately one-quarter of the population over the age of 75 years and more than half of all cardiac procedures performed on this age group, the number of potential elderly surgical candidates is increasing. However, data suggest that old age is associated with increased morbidity and mortality following cardiac surgery. Over the past 2 decades, improvements in myocardial protection, extracorporeal circulation, anesthesia, and surgical techniques have significantly reduced the morbidity and mortality associated with cardiac surgery. Although most prospective studies exclude elderly patients, data from large retrospective studies and subgroup analyses suggest that cardiac surgery is a viable option for many elderly patients with cardiovascular disease, with good outcomes observed in reasonable-risk candidates; moreover, there are a growing number of available less-invasive options for them when surgical risk becomes prohibitive. In this article, we discuss the current state of cardiovascular surgery in the elderly as well as emerging technologies on the horizon.

An 85-year-old woman presented with severe degenerative native mitral regurgitation (MR) in the setting of preserved left ventricular ejection fraction (LVEF) of 65%. Transesophageal echocardiograp...

BACKGROUND: Transcatheter aortic valve replacement (TAVR) for low gradient (LG) severe aortic stenosis (AS) with preserved left ventricular ejection fraction (LVEF) remains an area of clinical uncertainty. METHODS: Retrospective review identified 422 patients who underwent TAVR between September 4, 2014 and July 1, 2016. Procedural indication other than severe AS (n = 22) or LVEF ≤50% (n = 98) were excluded. Outcomes were defined by valve academic research consortium two criteria when applicable and compared between LG (peak velocity

Objectives This study sought to clarify the clinical and echocardiographic prognostic implication of myocardial injury after transcatheter aortic valve replacement (TAVR). Background The clinical significance of cardiac biomarker elevation after TAVR remains unclear. Methods Patients treated with TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) trial were divided into tertiles (T1, T2, T3) based on the difference between the values on post-procedure day 1 and the baseline values of 2 cardiac biomarkers: cardiac troponin I (ΔcTnI); and creatine kinase-myocardial band (ΔCK-MB) fraction. Patients were stratified according to their access route: transfemoral (TF) (n = 1,840) or transapical (TA) (n = 1,173). Results At 30 days after TF-TAVR, patients in the highest tertile (T3) of cardiac biomarker elevation had a higher rate of all-cause mortality (ΔcTnI: T3: 5.4% vs. T1: 0.5%, p = 0.006; ΔCK-MB: T3: 5.7% vs. T1: 0.9%, p = 0.006) and cardiovascular mortality (ΔcTnI: T3: 4.9% vs. T1: 0.5%, p = 0.01; ΔCK-MB: T3: 3.9% vs. T1: 0.5%, p = 0.02). At 1 year, only patients in the highest CK-MB tertile had higher rates of all-cause (25.4% vs. 16.8%, p = 0.02) and cardiovascular (10.3% vs. 5.0%) mortality. Multivariable analysis demonstrated that greater release of cardiac biomarkers was independently associated with increased mortality in the TF population. After TA-TAVR, being in the highest tertile of cardiac biomarker elevation had no influence on clinical and echocardiographic outcomes at 30 days and 1 year. Conclusions After TF-TAVR, a greater degree of myocardial injury was associated with higher rates of 30-day all-cause and cardiovascular mortality. At 1 year, being in the highest tertile of ΔCK-MB was correlated with a higher rate of all-cause and cardiac mortality. Finally, the level of myocardial injury after TA-TAVR had no impact on clinical and echocardiographic outcomes.

Balloon aortic valvuloplasty (BAV) was originally considered as an alternative to surgery for the treatment of aortic stenosis. However, due to the poor durability of its effects, it was largely relegated to palliative use. Recently, there has been increased application of BAV, particularly as a bridging procedure to transcatheter aortic valve replacement (TAVR) therapy. Furthermore, stand-alone BAV is now more frequently employed as palliative procedure for the growing population of older adults with aortic stenosis (AS) with limited life expectancy. Accordingly, BAV use has increased both in the USA and other countries, and this trend is expected to continue. The purpose of this review is to document trends in BAV use, data on effectiveness, and considerations in frail older adults in contemporary medical practice.

Many patients undergoing transcatheter aortic valve implantation (TAVI) have a pre-existing, permanent pacemaker (PPM) or receive one as a consequence of the procedure. We hypothesised that chronic pacing may have adverse effects on TAVI outcomes.Four groups of patients undergoing TAVI in the Placement of Aortic Transcatheter Valves (PARTNER) trial and registries were compared: prior PPM (n=586), new PPM (n=173), no PPM (n=1612), and left bundle branch block (LBBB)/no PPM (n=160). At 1 year, prior PPM, new PPM and LBBB/no PPM had higher all-cause mortality than no PPM (27.4%, 26.3%, 27.7% and 20.0%, p0.05), and prior PPM or new PPM had higher rehospitalisation or mortality/rehospitalisation (p0.04). By Cox regression analysis, new PPM (HR 1.38, 1.00 to 1.89, p=0.05) and prior PPM (HR 1.31, 1.08 to 1.60, p=0.006) were independently associated with 1-year mortality. Surviving prior PPM, new PPM and LBBB/no PPM patients had lower LVEF at 1 year relative to no PPM (50.5%, 55.4%, 48.9% and 57.6%, p0.01). Prior PPM had worsened recovery of LVEF after TAVI (Δ=10.0 prior vs 19.7% no PPM for baseline LVEF35%, p0.0001; Δ=4.1 prior vs 7.4% no PPM for baseline LVEF 35-50%, p=0.006). Paced ECGs displayed a high prevalence of RV pacing (88%).In the PARTNER trial, prior PPM, along with new PPM and chronic LBBB patients, had worsened clinical and echocardiographic outcomes relative to no PPM patients, and the presence of a PPM was independently associated with 1-year mortality. Ventricular dyssynchrony due to chronic RV pacing may be mechanistically responsible for these findings.(ClinicalTrials.gov NCT00530894).

Objectives: Del Nido cardioplegia in adult cardiac surgery has not been studied although it has been in common use as a “single” dose cardioplegia in pediatric heart surgery. We retrospectively assessed the short-term (in-hospital) clinical outcomes of patients undergoing aortic valve replacement (AVR) using del Nido cardioplegia solution, comparing it to conventional multi-dose whole blood cardioplegia. Methods: We switched our cardioplegia protocol from conventional whole blood cardioplegia exclusively to del Nido solution in May 2011. In 2011, 240 consecutive patients underwent isolated AVR. One hundred and seventy-eight of them were operated on with the use of del Nido cardioplegia (del Nido group) and whole blood cardioplegia (conventional group) was used in the other 62 patients. Isolated AVR was chosen as a cohort because of its relative simplicity and the similarity of surgical techniques among surgeons. Propensity-score matching identified 54 matched pairs for analysis. Results: The retrograde cardioplegia technique was used in 19 cases (35.2%) in the del Nido group and 52 cases (96.3%) in the conventional group (pConclusions: Short-term outcomes in adult cardiac surgery using del Nido solution were acceptable and comparable to conventional multi-dose whole blood cardioplegia. The del Nido cardioplegia technique was associated with shortened cross-clamp times and less frequent utilization of the retrograde cardioplegia delivery technique.

OBJECTIVES: Chronic kidney disease (CKD) is prevalent in patients undergoing aortic valve replacement (AVR). We sought to evaluate the impact of AVR on estimated glomerular filtration rate (eGFR) levels and determine the impact of reversibility of CKD on postoperative outcomes. METHODS: We retrospectively reviewed 2169 patients who underwent isolated AVR between 2000 and 2012. eGFR was calculated using the CKD-EPI formula. Based on preoperative eGFR, patients were divided into three groups: NoCKD (eGFR >60, n= 1417), ModCKD (eGFR = 30–60, n= 619) and SevCKD (eGFR = 15–30, n= 86). End-stage renal disease patients (eGFR

Background— In the Placement of AoRTic TraNscathetER Valve (PARTNER) randomized controlled trial (RCT), which represented the first exposure to transapical transcatheter aortic valve replacement (TA-TAVR) for many clinical sites, high-risk patients undergoing TA-TAVR derived similar health-related quality of life (HRQoL) outcomes when compared with surgical aortic valve replacement (SAVR). With increasing experience, it is possible that HRQoL outcomes of TA-TAVR may have improved. Methods and Results— We evaluated HRQoL outcomes at 1-, 6-, and 12-month follow-ups among 875 patients undergoing TA-TAVR in the PARTNER nonrandomized continued access (NRCA) registry and compared these outcomes with those of the TA-TAVR and SAVR patients in the PARTNER RCT. HRQoL was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes Study Short-Form 12, and the EuroQoL-5D, with the KCCQ overall summary score serving as the primary end point. The NRCA TA-TAVR and RCT TA-TAVR and SAVR groups were generally similar. The primary outcome, the KCCQ summary score, did not differ between the NRCA TA-TAVR and the RCT TA-TAVR group at any follow-up timepoints, although there were small differences in favor of the NRCA cohort on several KCCQ subscales at 1 month. There were no significant differences in follow-up HRQOL between the NRCA-TAVR and the RCT SAVR cohorts on the KCCQ overall summary scale or any of the disease-specific or generic subscales. Conclusions— Despite greater experience with TA-TAVR in the NRCA registry, HRQoL outcomes remained similar to those of TA-TAVR in the original RCT cohort and no better than those with SAVR. These findings have important implications for patient selection for TAVR when transfemoral access is not an option. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00530894.

Background— The higher risk of adverse outcomes after transapical (TA) versus transfemoral (TF) transcatheter aortic valve replacement (TAVR) could be attributable to TA-TAVR being an open surgical procedure or to clinical differences between TA- and TF-TAVR patients. We compared outcomes after neutralizing patient differences using propensity score matching. Methods and Results— From April 2007 to February 2012, 1100 Placement of Aortic Transcatheter Valves (PARTNER)-I patients underwent TA-TAVR and 1521 underwent TF-TAVR with Edwards SAPIEN balloon-expandable bioprostheses. Propensity matching based on 111 preprocedural variables, exclusive of femoral access morphology, identified 501 well-matched patient pairs (46% of possible matches), 95% of whom had peripheral arterial disease. Matched TA-TAVR patients experienced more adverse procedural events, longer length of stay (5 versus 8 days; P P =0.01); but aortic regurgitation was less (34% versus 52% mild and 8.9% versus 12% moderate to severe at discharge, P =0.001; 36% versus 50% mild and 10% versus 15% moderate to severe at 6 months, P Conclusions— The likelihood of adverse periprocedural events and prolonged recovery is greater after TA-TAVR than TF-TAVR in vasculopathic patients after accounting for differences in cardiovascular risk factors, although stroke risk is equivalent and aortic regurgitation is less. As smaller delivery systems permit TF-TAVR in many of these patients, we recommend a TF-first access strategy for TAVR when anatomically feasible. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00530894.

Summary Background The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that mortality at 1 year, 2 years, and 3 years is much the same with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for high-risk patients with aortic stenosis. We report here the 5-year outcomes. Methods We did this randomised controlled trial at 25 hospitals, in Canada (two), Germany (one), and the USA (23). We used a computer-generated randomisation sequence to randomly assign high-risk patients with severe aortic stenosis to either SAVR or TAVR with a balloon-expandable bovine pericardial tissue valve by either a transfemoral or transapical approach. Patients and their treating physicians were not masked to treatment allocation. The primary outcome of the trial was all-cause mortality in the intention-to-treat population at 1 year, we present here predefined outcomes at 5 years. The study is registered with ClinicalTrials.gov, number NCT00530894. Findings We screened 3105 patients, of whom 699 were enrolled (348 assigned to TAVR, 351 assigned to SAVR). Overall mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 11·7%. At 5 years, risk of death was 67·8% in the TAVR group compared with 62·4% in the SAVR group (hazard ratio 1·04, 95% CI 0·86–1·24; p=0·76). We recorded no structural valve deterioration requiring surgical valve replacement in either group. Moderate or severe aortic regurgitation occurred in 40 (14%) of 280 patients in the TAVR group and two (1%) of 228 in the SAVR group (p vs 56·6% for those with mild aortic regurgitation or less; p=0·003). Interpretation Our findings show that TAVR as an alternative to surgery for patients with high surgical risk results in similar clinical outcomes. Funding Edwards Lifesciences.

THE FOLLOWING iFORUM DEBATE FEATURES 3 VIEWPOINTS related to the most practical and effective imaging strategy for guiding transcatheter aortic valve replacement (TAVR). Kronzon, et al. provide evidence that enhanced analysis of abrtic valve anatomy and improved appreciation of complications mandate the use of transesophageal echocardiography as front-Line imaging modality for ALL patients undergoing TAVR. On the other hand, Saric and colleagues compare and contrast the approach of performing TAVR under transthoracic guidance. Lastly, Kasel and co-workers provide preliminary evidence that TAVR could be performed under fluoroscopic guidance without the need for additional imaging technique. Although the use of Less-intensive sedation or anesthesia might reduce the procedural time, we need more randomized data to establish the most cost-effective approach in guiding TAVR.

Recent multicenter trials have shown that transcatheter aortic valve replacement is an alternative to surgery in a high risk population of patients with severe, symptomatic aortic stenosis. Echocardiography and multislice computed tomographic imaging are accepted tools in the pre-procedural imaging of the aortic valve complex and vascular access. Transesophageal echocardiography can be valuable for intraprocedural confirmation of the landing zone morphology and measurements, positioning of the valve and post-procedural evaluation of complications. The current paper provides recommendations for pre-procedural and intraprocedural imaging used in assessing patients for transcatheter aortic valve replacement with either balloon-expandable or self-expanding transcatheter heart valves.

Objectives The purpose of this study was to identify predictors and clinical implications of permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR). Background Cardiac conduction disturbances requiring PPM are a frequent complication of TAVR. However, limited data is available regarding this complication after TAVR with a balloon-expandable valve. Methods The study included patients without prior pacemaker who underwent TAVR in the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry and investigated predictors and clinical effect of new PPM. Results Of 2,559 TAVR patients, 586 were excluded due to pre-existing PPM. A new PPM was required in 173 of the remaining 1,973 patients (8.8%). By multivariable analysis, predictors of PPM included right bundle branch block (odds ratio [OR]: 7.03, 95% confidence interval [CI]: 4.92 to 10.06, p Conclusions PPM was required in 8.8% of patients without prior PPM who underwent TAVR with a balloon-expandable valve in the PARTNER trial and registry. In addition to pre-existing right bundle branch block, the prosthesis to LV outflow tract diameter ratio and the LV end-diastolic diameter were identified as novel predictors of PPM after TAVR. New PPM was associated with a longer duration of hospitalization and higher rates of repeat hospitalization and mortality or repeat hospitalization at 1 year. (THE PARTNER TRIAL: Placement of AoRtic TraNscathetER Valves Trial; NCT00530894 )

We describe the use of the Sapien XT, placed in the mitral position using a totally endoscopic robotic approach in a 76-year-old man with extensive circumferential mitral calcifications and severe stenosis. The patient was at high risk for traditional open surgery and a large mitral valve annulus prevented safe transcatheter deployment due to size mismatch. Our novel approach offered a minimally invasive technique for native mitral valve replacement in a high-risk patient with anatomical constraints prohibitive to conventional approaches. doi: 10.1111/jocs.12737 (J Card Surg 2016;31:303-305).

A 77-year-old woman with a history of failed mitral valve (MV) repair with severe symptomatic mitral regurgitation underwent MV replacement with a 25-mm Carpentier-Edwards PERIMOUNT Magna bovine bioprosthesis (Edwards Lifesciences, Irvine, California) with resolution of symptoms. After 6 months

Objectives This study sought to evaluate the Medtronic Evolut PRO Transcatheter Aortic Valve System in patients with severe symptomatic aortic stenosis. Background A next-generation self-expanding transcatheter aortic valve was designed with an external pericardial wrap with the intent to reduce paravalvular leak while maintaining the benefits of a low-profile, self-expanding, and repositionable supra-annular valve. Methods The Medtronic Evolut PRO Clinical Study included 60 patients undergoing transcatheter aortic valve replacement with the Evolut PRO valve at 8 investigational sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. The 2 primary safety endpoints were the incidence of all-cause mortality at 30 days and the incidence of disabling stroke at 30 days. The primary efficacy endpoint was the proportion of patients with no or trace prosthetic valve regurgitation at 30 days. An independent echocardiographic core laboratory (Mayo Clinic, Rochester, Minnesota) was used to adjudicate all echocardiographic assessments. Results All 60 patients received the Evolut PRO valve. At 30 days, 1 patient (1.7%) died and 1 patient (1.7%) experienced a nonfatal disabling stroke. Paravalvular regurgitation at 30 days was absent or trace in 72.4% of patients and was mild in the remainder of patients, with no patients having worse than mild paravavlular leak. The mean atrioventricular gradient was 6.4 ± 2.1 mm Hg and effective orifice area was 2.0 ± 0.5 cm2 at 30 days. Conclusions The safety and efficacy results of this study support the use of the Evolut PRO System for the treatment of severe symptomatic aortic stenosis in patients who are at increased surgical risk, resulting in excellent hemodynamics and minimal paravalvular leak (The Medtronic TAVR 2.0 US Clinical Study; NCT02738853)

This paper provides a comprehensive overview of 3D transesophageal echocardiography still images and movies of mechanical mitral valves, mitral bioprostheses, and mitral valve repairs. Alongside these visual descriptions, the historical overview of surgical and percutaneous mitral valve intervention is described with the special emphasis on the incremental value of 3D transesophageal echocardiography (3DTEE). For each mitral valve intervention, 2D echocardiography, chest x-ray, and fluoroscopy images corresponding to 3DTEE are given. In addition, key references on echocardiographic imaging of individual valves and procedures are enumerated in accompanying figures and tables.

Background Nearly 17% of patients are readmitted within 30 days of discharge after transcatheter aortic valve replacement. Selected patients are discharged to skilled nursing facilities, yet the association between a hospital's practice to discharge home versus to skilled nursing facilities, and readmission remains unclear. Methods and Results The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry was used to evaluate readmissions among patients undergoing transcatheter aortic valve replacement (2011‐2015). Hospitals were divided into quartiles (Q1‐Q4) based on the percentage of patients discharged directly home. We assessed patient and hospital level characteristics and used hierarchical logistic regression to analyze the association of discharge disposition with 30‐day readmission. Our cohort included 18 568 transcatheter aortic valve replacement patients at 329 US hospitals, of whom 69% were discharged directly home. Hospitals in the highest quartile of direct home discharge (Q4) compared with hospitals in the lowest (Q1) were more likely to use femoral access (75.2% versus 60.1%, P P P P =0.14), even after multivariable adjustment (odds ratio Q4 versus Q1=0.89, 95% CI 0.76‐1.04; P =0.15). Factors most strongly associated with 30‐day readmission were glomerular filtration rate, in‐hospital stroke or transient ischemic attack, and nonfemoral access. Conclusions There was no statistically significant association between hospital practice of direct home discharge post–transcatheter aortic valve replacement and 30‐day readmission. Further research is needed to understand regional variations and optimum strategies for postdischarge care.

The technique of mechanical circulatory support or the site of cannulation may affect transvalvular flow. We describe early failure of a mitral bioprosthesis in a patient with temporary left ventricular assist device support, likely from thrombosis. Salvage with transcatheter mitral valve replacement was attempted. Temporary mechanical circulatory support strategies that maximize flow across a new bioprosthesis should be sought to avoid early valvular thrombosis.

Background— Appropriate valve sizing is critical in aortic valve replacement. We hypothesized that direct intraoperative valve sizing results in smaller aortic annular diameters compared with sizing based on systolic-phase multidetector computerized tomographic (MDCT) imaging. Methods and Results— We retrospectively analyzed 78 patients undergoing surgical aortic valve replacement for severe aortic stenosis between 2012 and 2014 at our institution. Preoperative MDCT measurements of the aortic annulus served as basis for assignment to a theoretical surgical valve size, which was then (1) compared to the implanted valve size and (2) to a theoretical transcatheter aortic valve replacement valve size. To quantify the resulting differences, geometric orifice areas (GOA) were calculated. MDCT-based sizing produced the same valve size for n=34 patients (group CT-same), a larger valve with a 25% increased GOA in n=32 patients (group CT-Lg) and a smaller GOA by 22% in n=12 patients (group CT-Sm). On the basis of MDCT measurements, 41% of valves implanted were undersized. The comparison of intraoperative implanted to a theoretical transcatheter aortic valve replacement valve size resulted in GOAs 25% larger for patients in group CT-same, 40.6% larger in group CT-Lg and 14.6% larger in group CT-Sm. Conclusions— Preoperative MDCT measurements differ substantially from direct intraoperative assessment of the aortic annulus. Implanted surgical aortic valve replacement valves were smaller relative to MDCT-based sizing in 41% of patients, and the potential GOA was between 25% and 40.6% larger if patients had undergone transcatheter aortic valve replacement.

Atrial fibrillation (AF) is associated with worse outcomes in many cardiovascular diseases. There are few data examining pacemaker implantation rates and indications in patients with AF who undergo transcatheter aortic valve replacement (TAVR). To examine the impact of AF on the incidence of and indications for pacemakers in patients undergoing TAVR, we evaluated data of 1723 patients without pre-existing pacemakers who underwent TAVR in the Placement of AoRTic TraNscathetER Valve (PARTNER) trial. Permanent pacemaker implantation rates and indications were compared in groups based on baseline and discharge heart rhythm: sinus rhythm (SR) vs. AF. 1211 patients manifested SR at baseline/SR at discharge (SR/SR), 105 SR baseline/AF discharge (SR/AF), and 407 AF baseline/AF discharge (AF/AF). Patients who developed and were discharged with AF (SR/AF) had the highest rates of pacemaker implantation at 30 days (13.7% SR/AF vs. 5.4% SR/SR, p=0.0008 and 5.9% AF/AF, p=0.008) and 1 year (17.7% SR/AF vs. 7.1% SR/SR, p=0.0002 and 8.1% AF/AF, p=0.0034). Conversion from SR to AF by discharge was an independent predictor of increased pacemaker implantation at 30 days (HR 2.19 vs. SR/SR, 95% CI 1.23-3.93, p=0.008) and 1 year (HR 1.91 vs. SR/SR, 95% CI 1.33-3.80). Pacemaker indications differed between groups, with relatively more implanted in the AF groups for sick sinus syndrome (SSS) versus AV block. In conclusion, conversion to AF is an independent predictor of permanent pacemaker implantation in TAVR patients. Indications differ depending on heart rhythm, with patients in AF manifesting clinically significant tachy-brady syndrome versus AV block.

Background— The long-term outcomes of transcatheter aortic valve replacement (TAVR) in inoperable patients with severe aortic stenosis remain unknown. Methods and Results— In the Placement of Aortic Transcatheter Valves (PARTNER) study, 358 patients were randomly assigned to TAVR or standard therapy. We report the 3-year outcomes on these patients, and the pooled outcomes for all randomly assigned inoperable patients (n=449) in PARTNER, as well, including the randomized portion of the continued access study (n=91). The 3-year mortality rate in the TAVR and standard therapy groups was 54.1% and 80.9%, respectively ( P P P =0.012); however, the composite of death or strokes was significantly lower after TAVR versus standard therapy (57.4% versus 80.9%, P hazard ratio, 0.60; 95% confidence interval, 0.46–0.77; P Conclusions— TAVR resulted in better survival and functional status in inoperable patients with severe aortic stenosis with durable hemodynamic benefit on long-term follow-up. However, high residual mortality, even in successfully treated TAVR patients, highlights the need for more strategic patient selection. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00530894.

Objectives This study sought to characterize the patients receiving post-implantation balloon dilation (PD) following transcatheter aortic valve replacement (TAVR) and evaluate procedural outcomes in the PARTNER (Placement of Aortic Transcatheter Valve) I trial. Background Following TAVR, PD has been used to treat paravalvular regurgitation. Methods The PARTNER I trial cohort A (n = 304) and cohort B (n = 194) patients randomized to TAVR and the nonrandomized continued access TAVR (n = 1,637) patients were included in the analysis. PD was performed at the discretion of the operator. Clinical events and echocardiographic variables were collected prospectively out to 1 year. Results The overall incidence of PD was 12.4%. PD patients had significantly less prosthesis-patient mismatch (p 30 days (1.9 vs. 1.7%; p = 0.75). Although there was no significant increase in early mortality with PD, at 1 year, there was a trend for higher all-cause mortality (p = 0.054) and a significant difference in death or stroke (p = 0.04). When the subgroup of patients with none/trace paravalvular regurgitation were evaluated, there was no significant association of PD with mortality (p = 0.61) and death or stroke (p = 0.96). Multivariable analysis failed to show a relationship between PD and mortality. Conclusions PD is associated with reduced rates of moderate or severe prosthesis-patient mismatch with no evidence for short-term structural deterioration of the balloon-expandable transcatheter valve. Although PD is associated with a greater incidence of early stroke, there is no significant association between PD and stroke beyond 7 days. Multivariable analysis shows no significant association between PD and mortality.

The Placement of Aortic Transcatheter Valves (PARTNER) trial reported a reduced rate of mortality in patients with previous coronary bypass grafting (CABG) operation who received surgical aortic valve replacement (SAVR) in comparison with transcatheter aortic valve replacement (TAVR). We sought to further evaluate these groups.We reviewed the database of the 699 patients enrolled in the PARTNER trial. The cohort for this study consisted of 288 patients (41.2%) who had a history of CABG operation before enrollment in the PARTNER trial. All patients were followed up for 2 years.The mean age was 81.5±6.6 years, and 231 patients (80.2%) were men. The preoperative characteristics were similar in 140 patients (48.6%) who received SAVR and 148 (51.4%) who received TAVR. There were no differences between the two groups with respect to the operative outcomes of death, stroke, and myocardial infarction, but the TAVR patients experienced more paravalvular regurgitation (p0.0001). At 2 years, there was a trend toward greater all-cause mortality in the TAVR patients (hazard ratio [HR] 1.53; 95% confidence interval [CI]: 0.99, 2.35; p=0.052). Furthermore, the TAVR patients had more repeated hospitalization (HR 1.75; 95% CI: 0.99, 3.07; p=0.05), death of any cause or repeated hospitalization (HR 1.52; 95% CI: 1.06, 2.19; p=0.02), and death of any cause or stroke (HR 1.51; 95% CI: 1.00, 2.27; p=0.05).The 2-year follow-up of patients with a history of previous CABG operation in the PARTNER trial demonstrated improved outcomes with SAVR in comparison with TAVR. Further longitudinal assessment is necessary to corroborate these findings and to understand the possible causes.

Background Patients with severe aortic stenosis (AS) who were deemed too high risk or inoperable for conventional aortic valve replacement (AVR) in the PARTNER (Placement of Aortic Transcatheter Valves) trial were randomized to transcatheter aortic valve replacement (TAVR) versus AVR (PARTNER-A arm) or standard therapy (PARTNER-B arm). Objectives This study compared when and how deaths occurred after TAVR versus surgical AVR or standard therapy. Methods The PARTNER-A arm included 244 transfemoral (TF) and 104 transapical (TA) TAVR patients, and 351 AVR patients; the PARTNER-B arm included 179 TF-TAVR patients and 179 standard therapy patients. Deaths were categorized as cardiovascular, noncardiovascular, or uncategorizable, and were characterized by multiphase hazard modelling. Results In the PARTNER-A arm, the risk of death peaked after randomization in the TA-TAVR and AVR groups, falling to low levels commensurate with the U.S. population within 3 months. Early risk was less in TF-TAVR patients, resulting in initial superior survival; between 12 and 18 months, risk increased, such that within 2 years, TF-TAVR and AVR patients had similar survival rates. Cardiovascular, noncardiovascular, and uncategorizable deaths for TF-TAVR were 37%, 43%, and 20%, respectively, versus 22%, 41%, and 37%, respectively, for TA-TAVR and 33%, 43%, and 24%, respectively, for AVR. In the PARTNER-B arm, risk with standard therapy was 60% per year; TF-TAVR reduced risk to 20% per year, resulting in 0.5 years of life added within 2.5 years. Conclusions In inoperable AS patients, TAVR substantially reduced the risk of cardiovascular death. In high-risk patients, TA-TAVR and AVR were associated with elevated peri-procedural risk more than with TF-TAVR, although cardiovascular death was higher after TF-TAVR. Therefore, TF-TAVR should be considered the standard of care for severely symptomatic inoperable patients or those at high risk of noncardiovascular mortality after conventional surgery. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894)

Background and Aims The immediate postischemic period is marked by elevated intracellular calcium levels, which can lead to irreversible myocyte injury. Del Nido cardioplegia was developed for use in the pediatric population to address the inability of immature myocardium to tolerate high levels of intracellular calcium following cardiac surgery. Our aim in this study is to determine if this solution can be used safely and effectively in an adult, reoperative population. Methods All patients undergoing isolated reoperative aortic valve replacement at our institution from 2010 to 2012 were retrospectively reviewed. Demographics, comorbidities, operative variables, postoperative complications, and patient outcomes were collected. Patients were divided into two groups based on cardioplegia strategy used: whole blood cardioplegia (WB, n = 61) and del Nido cardioplegia (DN, n = 52). Results Mean age in the study was 73.4 ± 14.3 years and 86 patients were male (76.1%). Eighty-four patients had undergone prior coronary artery bypass graft (CABG) (74.3%). Patients in the DN group required significantly lower total volume of cardioplegia (1147.6 ± 447.2 mL DN vs. 1985.4 ± 691.1 mL WB, p

Objectives This study sought to examine sex-specific differences in outcomes after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) in high-risk patients with severe aortic stenosis. Background The PARTNER (Placement of Aortic Transcatheter Valve) trial demonstrated similar 2-year survival with SAVR or TAVR for high-risk patients, but sex-specific outcomes are unknown. Methods In all, 699 patients (300 female) were randomly assigned 1:1 to either SAVR or TAVR with a balloon expandable pericardial tissue valve. Baseline characteristics and 2-year outcomes of TAVR versus SAVR were compared among males and females. Results Baseline characteristics differed between the sexes. Despite higher Society of Thoracic Surgeons mortality risk scores (11.9 vs. 11.6; p = 0.05), female patients had lower prevalence of coronary artery disease (64.4% vs. 83.7%), prior coronary artery bypass graft surgery (19.8% vs. 61.2%), peripheral vascular disease (36.4% vs. 46.9%), diabetes mellitus (35.6% vs. 45.6%), and elevated creatinine (11.7% vs. 23.9%). Among female patients, procedural mortality trended lower with TAVR versus SAVR (6.8% vs. 13.1%; p = 0.07) and was maintained throughout follow-up (hazard ratio [HR]: 0.67; 95% confidence interval [CI]: 0.44 to 1.00; p = 0.049), driven by the transfemoral arm (HR: 0.55; 95% CI: 0.32 to 0.93; p = 0.02). Among male patients, although procedural mortality was lower with TAVR (6% vs. 12.1%; p = 0.03), there was no overall survival benefit (HR: 1.15; 95% CI: 0.82 to 1.61; p = 0.42). Conclusions In this retrospective subanalysis of high-risk, symptomatic aortic stenosis patients in the PARTNER trial, female subjects had lower late mortality with TAVR versus SAVR. This was especially true among patients suitable for transfemoral access and suggests that TAVR may be preferred over surgery for high-risk female patients. A randomized, controlled trial conducted specifically in female patients is necessary to properly study differences in mortality between treatment modalities. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894 )

Objectives This study sought to identify the incidence, predictors, and prognostic impact of bleeding complications (BC) after surgical aortic valve replacement (SAVR) compared with transcatheter aortic valve replacement (TAVR). Background Bleeding complications after SAVR and TAVR are frequent and may be associated with an unfavorable prognosis. Methods In the randomized controlled PARTNER (Placement of Aortic Transcatheter Valve) I trial, 657 patients from cohort A (operable high risk) were randomly assigned to SAVR or TAVR (transfemoral [TF] if iliofemoral access was suitable or transapical [TA] if not) and received the designated treatment. First-generation Edwards SAPIEN valves and delivery systems (Edwards Lifesciences, Irvine, California) were used for TAVR, through a 22- or 24-F sheath. The 30-day rates of major BC (modified Valve Academic Research Consortium definitions), predictors of BC, and their association with 1-year mortality were assessed. Results A total of 71 (22.7%), 27 (11.3%), and 9 (8.8%) patients had major BC within 30 days of the procedure after SAVR, TF-TAVR, and TA-TAVR, respectively (p Conclusions Among high-risk aortic stenosis patients enrolled in the PARTNER I randomized trial, BC were more common after SAVR than after TAVR and were also associated with a worse long-term prognosis. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894 )

The treatment of calcified coronary lesions by percutaneous coronary intervention has been shown to be associated with poor outcomes and an increased rate of complications. However, the impact of coronary calcification in patients undergoing coronary artery bypass grafting (CABG) is unknown. A total of 755 patients presenting with acute coronary syndrome in the Acute Catheterization and Urgent Intervention Triage Strategy trial underwent CABG. Patients were divided into 3 groups according to the presence and extent of coronary calcifications (lesion level: severe, moderate, none to mild) as assessed by an independent angiographic core laboratory. Major ischemic and bleeding outcomes were assessed at 30 days and 1 year. Severe calcification was found in 103 patients (13.6%), moderate calcification in 249 patients (33.0%), and none-to-mild calcification in 403 patients (53.4%). The presence of severe calcification compared with moderate or none to mild was associated with a significantly higher unadjusted rate of death (11.8% vs 3.7% vs 4.5%, p = 0.006), death or myocardial infarction (MI; 31.1% vs 19.7% vs 16.4%, p = 0.006), and major adverse cardiac event (MACE; 32.0% vs 22.6% vs 20.8%, p = 0.059) at 1 year. By multivariate analysis, severe calcification (vs nonsevere calcification) was identified as an independent predictor of 1-year MACE (hazard ratio 1.49, 95% confidence interval 1.01 to 2.21, p = 0.04) and death or MI (hazard ratio 1.77, 95% confidence interval 1.18 to 2.66, p = 0.006). In conclusion, the presence of severe coronary calcification was associated with worse outcomes after CABG, including an increased risk of death. The presence of severe coronary calcification was identified as an independent predictor of MACE and death or MI 1 year after CABG.

Background Transapical (TA) aortic valve replacement was an integral part of the Placement of Transcatheter Aortic Valves (PARTNER) trial. Enrollment during the randomized trial included 104 transapical (premarket approval TA [PMA-TA]) and 92 surgical aortic valve replacements (SAVR) within the TA cohort. On completion of the trial, enrollment continued in a nonrandomized continued access (NRCA) program. We compared the outcomes of NRCA-TA procedures with those of PMA-TA and SAVR. Methods In 22 centers, 975 patients underwent TA aortic valve replacement as part of the NRCA registry. Inclusion and exclusion criteria were unchanged from the previously reported PARTNER trial. All patients were followed up for at least 1 year. Results Thirty-day or in-hospital mortality was 8.8% for the NRCA-TA cohort, compared with 10.6% and 12.0% for the PMA-TA and SAVR patients, respectively ( p = 0.54). One-year mortality in the NRCA-TA cohort was 22.1%, not significantly lower than the mortality in PMA-TA and SAVR patients at 29.0% and 25.3%, respectively ( p = 0.27). Thirty-day or in-hospital stroke was 2.2% among NRCA-TA patients in contrast to the 6.7% stroke rate observed in the PMA-TA group and 5.4% in SAVR patients ( p = 0.008). Lower rates of neurologic adverse events in the NRCA-TA group persisted at 1 year compared with the PMA-TA and SAVR patients. Conclusions Among the 975 patients in the NRCA-TA cohort, rates of major outcomes including death and stroke compared favorably with outcomes of PMA-TA and SAVR patients enrolled in the PARTNER trial. This trend toward improved outcomes may be attributed to improved patient selection, individual centers surmounting the procedural learning curve, and refinements in surgical technique.

Aims Cardiac conduction disturbances, including a left bundle branch block (LBBB), occur frequently following transcatheter aortic valve replacement (TAVR) and may be associated with adverse clinical events. This analysis examines the incidence and implications of new onset, persistent LBBB in patients undergoing TAVR with a balloon-expandable valve. Methods and results Patients undergoing TAVR in the Placement of Aortic Transcatheter Valves (PARTNER) trial and continued access registries with baseline and discharge/7-day electrocardiograms were included. Prior permanent pacemaker implantation (PPI) and baseline intraventricular conduction abnormalities were exclusion criteria. Predictors of new LBBB were identified and outcomes compared between patients with and without new LBBB. New LBBB occurred in 121 of 1151 (10.5%) patients and persisted in more than half at 6 months to 1 year. The only predictor of new LBBB was prior coronary artery bypass grafting. New LBBB was not associated with significant differences in 1-year mortality, cardiovascular mortality, repeat hospitalization, stroke, or myocardial infarction. However, it was associated with increased PPI during hospitalization (8.3 vs 2.8%, P = 0.005) and from discharge to 1 year (4.7 vs. 1.5%, P = 0.01). The ejection fraction failed to improve after TAVR in patients with new LBBB and remained lower at 6 months to 1 year (52.8 vs. 58.1%, P < 0.001). Conclusion Persistent, new-onset LBBB occurred in 10.5% of patients without intraventricular baseline conduction who underwent TAVR in the PARTNER experience. New LBBB was not associated with death, repeat hospitalization, stroke, or myocardial infarction at 1 year, but was associated with a higher rate of PPI and failure of left ventricular ejection fraction to improve.

Background Studies evaluating three-dimensional echocardiographic (3DE) annular sizing for balloon-expandable transcatheter aortic valve replacement (TAVR) are limited. In this study, a retrospective analysis of transesophageal echocardiographic images was performed to assess the feasibility of multiplanar measurements of annular dimensions by the novel off-label use of commercially available 3DE software and correlate annular sizing with severity of paravalvular regurgitation (PVR). Methods Intraprocedural transesophageal echocardiography was performed in 58 patients undergoing TAVR for severe, symptomatic aortic stenosis. Off-label use of commercially available software was used to measure transesophageal 3DE volumes. Pre-TAVR annular linear dimensions included two-dimensional echocardiographic sagittal diameter and 3DE measurements of minimal diameter, maximal diameter (MaxDiam), and the average or mean diameter. Three-dimensional echocardiographic average annular diameter derived from annular perimeter (AveAnnDiam P ) and average annular diameter derived from annular area (AveAnnDiam A ) were calculated. A cover index was calculated using each measurement. Short-axis PVR color jet areas were summed after deployment and at the end of study. Results Two-dimensional echocardiographic sagittal diameter was significantly smaller than 3DE MaxDiam ( P P ( P = .017), significantly larger than 3DE minimal diameter ( P P = .36) and AveAnnDiam A ( P = .38). There was a linear relationship between all 3DE annular measurements and immediate post-TAVR PVR area ( P ≤ .0001), with the largest R 2 value (0.48) for 3DE MaxDiam, 3DE AveAnnDiam P , and 3DE AveAnnDiam A . The largest areas under the curve to detect greater than mild PVR were for 3DE AveAnnDiam P cover index (0.772) and 3DE AveAnnDiam A cover index (0.769). Intraclass correlation coefficients for interobserver and intraobserver variability were high for 3DE AveAnnDiam P and 3DE AveAnnDiam A and lower for 3DE MaxDiam. Conclusions Using a novel approach to 3DE annular measurements, 3DE AveAnnDiam P and 3DE AveAnnDiam A can be reliably measured and correlate best with post-TAVR PVR area. New sizing algorithms with 3DE measurements should be developed.

Background— The prognosis and treatment of patients with low-flow (LF) severe aortic stenosis are controversial. Methods and Results— The Placement of Aortic Transcatheter Valves (PARTNER) trial randomized patients with severe aortic stenosis to medical management versus transcatheter aortic valve replacement (TAVR; inoperable cohort) and surgical aortic valve replacement versus TAVR (high-risk cohort). Among 971 patients with evaluable echocardiograms (92%), LF (stroke volume index ≤35 mL/m 2 ) was observed in 530 (55%); LF and low ejection fraction (P =0.006). In the inoperable cohort, patients with LF had higher mortality than those with normal flow, but both groups improved with TAVR (46% versus 76% with LF and 38% versus 53% with normal flow; P P =0.02). LF was an independent predictor of mortality in all patient cohorts (hazard ratio, ≈1.5), whereas ejection fraction and gradient were not. Conclusions— LF is common in severe aortic stenosis and independently predicts mortality. Survival is improved with TAVR compared with medical management and similar with TAVR and surgical aortic valve replacement. A measure of flow (stroke volume index) should be included in the evaluation and therapeutic decision making of patients with severe aortic stenosis. Clinical Trial Registration— URL: http://www.clinicaltrial.gov . Unique identifier: NCT0053089.4.

Patients with severe aortic stenosis are commonly elderly and with significant comorbidity. Surgical intervention can improve symptoms and survival in severe aortic stenosis. However, a large proportion of patients do not undergo surgical intervention because they are deemed to be inoperable or too high risk. Over the last decade, transcatheter aortic valve replacement (TAVR) has been developed, providing an effective, less-invasive alternative to open cardiac surgery for inoperable or high-risk patients. The purpose of this review is to provide an overview of risk assessment in TAVR. Specifically, this article reviews the epidemiology of aortic stenosis, describes the risks and benefits of TAVR across multiple outcome measures, explores frailty and other elderly risk factors as metrics for improved risk assessment and discusses the application of improved risk assessment in TAVR decisions.

Endovascular therapy for peripheral vascular and valvular disease has rapidly expanded and yet also produced new challenges for vascular access and closure. Current generation thoracic endograft (TEVAR) outer diameter sheath sizes range from 18 to 25 French, and the options for vascular access closure include off-label use of a closure device versus surgical cutdown. We describe a patient with a complex, post-dissection, descending aortic aneurysm who required TEVAR and had a vascular access complication repaired with stent exteriorization with open repair.

Paravalvular leak (PVL) is a frequent complication of transcatheter aortic valve replacement (TAVR) and is seen at a much higher rate after TAVR than after conventional surgical aortic valve replacement. Recent reports indicating that PVL may be correlated with increased late mortality have raised concerns. However, the heterogeneity of methods for assessing and quantifying PVL, and lack of consistency in the timing of such assessments, is a hindrance to understanding its true prevalence, severity, and effect. This literature review is an effort to consolidate current knowledge in this area to better understand the prevalence, progression, and impact of post-TAVR PVL and to help direct future efforts regarding the assessment, prevention, and treatment of this troublesome complication.

Background— Paravalvular regurgitation (PVR) is common after transcatheter aortic valve replacement (TAVR) and may be associated with adverse outcomes. Postdilatation (PD) has been proposed to treat PVR without being formally studied. We performed a study to evaluate the safety and efficacy of PD after balloon expandable TAVR. Methods and Results— Consecutive cases of TAVR were reviewed for clinical outcomes. Procedural transesophageal echocardiography imaging was reviewed for a subgroup of consecutive patients. PVR areas seen on a short-axis view were measured immediately after deployment, after PD, and at the completion of the study. Stent dimensions measured using angiography and the Paieon’s C-THV system pre- and post-PD were compared. Between May 2007 and November 2011, 259 patients underwent TAVR at our institution. PD was performed in 106 patients (41%). These patients had larger annulus, lower cover-index; more often had transfemoral access and implantation of a 26 mm valve. There was a nonsignificant greater rate of cerebrovascular events in PD patients. There was no significant difference in major aortic injury and permanent pacemaker implantation rates between groups. TTE studies were reviewed in 58 patients (35 with PD and 23 without PD). PD patients had larger PVR areas immediately after deployment (40.3±17.1 versus 15.4±14.2 mm 2 ; P 2 ; P Conclusions— This study demonstrates the efficacy of PD at reducing PVR in patients with greater than mild PVR after balloon-expandable TAVR.

Acute kidney injury (AKI) is associated with a poor prognosis after transcatheter aortic valve replacement (TAVR). A paucity of data exists regarding the incidence and effect of AKI after TAVR using the new recommended Valve Academic Research Consortium criteria. At Columbia University Medical Center, 218 TAVR procedures (64.2% transfemoral, 35.8% transapical) were performed from 2008 to July 2011. The creatinine level was evaluated daily until discharge. Using the Valve Academic Research Consortium definitions, the 30-day and 1-year outcomes were compared between patients with significant AKI (AKI stage 2 or 3) and those without significant AKI (AKI stage 0 or 1). Significant AKI occurred in 18 patients (8.3%). Of these 18 patients, 10 (55.6%) had AKI stage 3 and 9 (50%) required dialysis. AKI was associated with a lower baseline mean transvalvular gradient (37.6 ± 11.4 vs 45.6 ± 14.8 mm Hg for no AKI, p = 0.03). After TAVR, the AKI group had a greater hemoglobin decrease (3.6 ± 2.0 vs 2.4 ± 1.3 g/dl, p = 0.01), greater white blood cell elevation at 72 hours (21.09 ± 12.99 vs 13.18 ± 4.82 × 103/μl, p = 0.001), a more severe platelet decrease (118 ± 40 vs 75 ± 43 × 103/μl, p

We present a case of transcatheter closure of a traumatic ventricular septal defect (VSD), in which simultaneous 3-dimensional (3D) transesophageal echocardiography (TEE) and angiography played a critical role in defect sizing, device selection, and procedural guidance.

Importance Low-flow (LF) severe aortic stenosis (AS) is an independent predictor of mortality in patients undergoing aortic valve replacement (AVR). Little is known about improvement in flow after AVR and its effects on survival. Objective To determine whether higher flow (left-ventricular stroke volume index [LVSVI]) after transcatheter AVR (TAVR) would indicate better clinical outcomes in this at-risk population. Design, Setting, and Participants A substudy analysis of data from the Placement of Aortic Transcatheter Valves (PARTNER) randomized clinical trial and continued-access registry was conducted. A total of 984 participants with evaluable echocardiograms and baseline LF AS (LVSVI ≤35 mL/m 2 ) were included. The trial was conducted at 26 sites in the United States and Canada. Patients were stratified after TAVR into tertiles by discharge LVSVI status (severe low flow [SLF], moderate low flow [MLF], and normal flow [(NF]). The present study was conducted from May 11, 2007, to January 9, 2012, with data analysis performed from April 25, 2014, to January 21, 2016. Main Outcomes and Measures The primary end point was all-cause mortality at 1 year. Results Baseline characteristics of 984 patients with LF AS included mean (SD) age, 84 (7) years; 582 (59.1%) men; mean Society of Thoracic Surgeons (STS) score, 11.4% (4.0%); and mean LVSVI, 27.6 (5.0) mL/m 2 . The discharge LVSVI values by group were SLF, 23.1 (3.5) mL/m 2 ; MLF, 31.7 (2.2) mL/m 2 ; and NF, 43.1 (7.0). All-cause mortality at 1 year was SLF, 26.5%; MLF, 20.1%; and NF, 19.6% ( P = .045). Mean LVSVI normalized by 6 months in the MLF (35.9 [9.3] mL/m 2 ) and NF (38.8 [11.1] mL/m 2 ) groups, but remained low in the SLF group at 6 months and 1 year (31.4 [8.4] and 33.0 [8.3] mL/m 2 ], respectively) ( P P = .004). In addition to SLF, sex (1.59; 95% CI, 1.18-2.13; P = .002), presence of atrial fibrillation (1.41; 95% CI, 1.06-1.87; P = .02), STS score (1.03; 95% CI, 1.01-1.06; P = .02), presence of moderate or severe mitral regurgitation at discharge (1.65; 95% CI, 1.21-2.26; P = .001), pre-TAVR mean transvalvular gradient (0.98; 95% CI, 0.97-0.99; P = .004), and effective orifice area index (1.87; 95% CI, 1.09-3.19; P = .02) were independent predictors of 1-year mortality. Conclusions and Relevance Severe LF at discharge is associated with an increased risk of mortality following TAVR in patients with severe AS and preexisting LF. The identification of remedial causes of persistent LF after TAVR may represent an opportunity to improve the outcome of these patients. Trial Registration clinicaltrials.gov Identifier:NCT00530894

Background Bundled Payments for Care Improvement (BPCI) initiatives were developed by Medicare in an effort to reduce expenditures while preserving quality of care. Payment model 2 reimburses based on a target price for 90-day episode of care postprocedure. The challenge for valve patients is the historically high (>35%) 90-day readmission rate. We analyzed our institutional cardiac surgical service line adaptation to this initiative. Methods On May 1, 2015, we instituted a readmission reduction initiative (RRI) that included presurgical risk stratification, comprehensive predischarge planning, and standardized postdischarge management led by cardiac nurse practitioners (CNPs) who attempt to guide any postdischarge encounters (PDEs). A prospective database also was developed, accruing data on all cardiac surgery patients discharged after RRI initiation. We analyzed detailed PDEs for all valve patients with complete 30-day follow-up through November 2015. Results Patients included 219 surgical patients and 126 transcatheter patients. Sixty-four patients had 79 PDEs. Of these 79 PDEs, 46 (58.2%) were guided by CNPs. PDEs were due to fluid overload/effusion (21, 27%), arrhythmia (17, 22%), bleeding/thromboembolic events (13, 16%), and falls/somatic complaints (12, 15%). Thirty-day readmission rate was 10.1% (35/345). Patients with transcatheter aortic valve replacement had a higher rate of readmission than surgical patients (15.0% vs 6.9%), but were older with more comorbidities. The median readmission length of stay was 2.0 days (interquartile range 1.0–5.0 days). Compared with 2014, the 30-day readmission rate for BPCI decreased from 18% (44/248) to 11% (20/175), P = .05. Conclusions Our reengineering of pre/postdischarge management of BPCI valve patients under tight CNP control has significantly reduced costly 30-day readmissions in this high-risk population.

This study sought to evaluate this transcatheter aortic valve (TAV) bioprosthesis in patients who are poorly suitable for surgical aortic valve (AV) replacement.A novel self-expandable TAV bioprosthesis was designed to provide a low-profile delivery system, conformable annular sealing, and the ability to resheath and reposition during deployment.The Evolut R U.S. study included 241 patients with severe aortic stenosis who were deemed to be at least high risk for surgery treated at 23 clinical sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. An independent echocardiography laboratory was used to evaluate hemodynamic outcomes.Patients were elderly (83.3 ± 7.2 years of age) and had high surgical risk (Society of Thoracic Surgeons predicted risk of mortality of 7.4 ± 3.4%). The majority of patients (89.5%) were treated by iliofemoral access. Resheathing or recapturing was performed in 22.6% of patients; more than 1 valve was required in 3 patients (1.3%). The 30-day outcomes included all-cause mortality (2.5%), disabling stroke (3.3%), major vascular complications (7.5%), life-threatening or disabling bleeding (7.1%), and new permanent pacemaker (16.4%). AV hemodynamics were markedly improved at 30 days: the mean AV gradient was reduced from 48.2 ± 13.0 mm Hg to 7.8 ± 3.1 mm Hg (p 0.001) and AV area increased from 0.6 ± 0.2 cmWe conclude that this novel self-expanding TAV bioprosthesis is safe and effective for the treatment of patients with severe aortic stenosis who are suboptimal for surgery. (Medtronic CoreValve Evolut R U.S. Clinical Study; NCT02207569).

We describe the use of the Sapien XT, placed in the mitral position using a totally endoscopic robotic approach in a 76-year-old man with extensive circumferential mitral calcifications and severe stenosis. The patient was at high risk for traditional open surgery and a large mitral valve annulus prevented safe transcatheter deployment due to size mismatch. Our novel approach offered a minimally invasive technique for native mitral valve replacement in a high-risk patient with anatomical constraints prohibitive to conventional approaches. doi: 10.1111/jocs.12737 (J Card Surg 2016;31:303-305).

Previous trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients.We randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort.The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan-Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). In the transfemoral-access cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P=0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation.In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).

BACKGROUND Female sex is associated with poorer outcomes after surgical aortic valve replacement (SAVR). Data on sex-specific differences after transcatheter aortic valve replacement (TAVR) are conflicting. OBJECTIVE To examine sex-specific differences in patients undergoing TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) trial. DESIGN Secondary analysis of the randomized and nonrandomized portions of the PARTNER trial. (ClinicalTrials.gov: NCT00530894). SETTING 25 hospitals in the United States, Canada, and Germany. PATIENTS High-risk and inoperable patients (1220 women and 1339 men). INTERVENTION TAVR. MEASUREMENTS Demographic characteristics, cardiac and noncardiac comorbidities, mortality, stroke, rehospitalization, vascular complications, bleeding complications, and echocardiographic valve parameters. RESULTS At baseline, women had lower rates of hyperlipidemia, diabetes, smoking, and renal disease but higher Society of Thoracic Surgeons Predicted Risk of Mortality scores (11.9% vs. 11.1%; P < 0.001). After TAVR, women had more vascular complications (17.3% vs. 10.0%; difference, 7.29 percentage points [95% CI, 4.63 to 9.95 percentage points]; P < 0.001) and major bleeding (10.5% vs. 7.7%; difference, 2.8 percentage points [CI, 0.57 to 5.04 percentage points]; P = 0.012) but less frequent moderate and severe paravalvular regurgitation (6.0% vs. 14.3%; difference, -8.3 percentage points [CI, -11.7 to -5.0 percentage points]; P < 0.001). At 30 days, the unadjusted all-cause mortality rate (6.5% vs. 5.9%; difference, 0.6 percentage point [CI, -1.29 to 2.45 percentage points]; P = 0.52) and stroke incidence (3.8% vs. 3.0%; difference, 0.8 percentage point [CI, -0.62 to 2.19 percentage points]; P = 0.28) were similar. At 1 year, all-cause mortality was significantly lower in women than in men (19.0% vs. 25.9%; hazard ratio, 0.72 [CI, 0.61 to 0.85]; P < 0.001). LIMITATION Secondary analysis that included nonrandomized trial data. CONCLUSION Despite a higher incidence of vascular and bleeding complications, women having TAVR had lower mortality than men at 1 year. Thus, sex-specific risk in TAVR is the opposite of that in SAVR, for which female sex has been shown to be independently associated with an adverse prognosis. PRIMARY FUNDING SOURCE Edwards Lifesciences.

Transcatheter aortic valve replacement is increasingly performed as a minimally invasive treatment option for aortic valve disease. The typical anesthetic management for this procedure was traditionally similar to surgical aortic valve replacement and involved general anesthesia and transesophageal echocardiography. In this review, we discuss the technological advances in transcatheter valve systems that have improved outcomes and allow for use of sedation instead of general anesthesia. We describe an anesthetic protocol that avoids general anesthesia and utilizes transthoracic echocardiography for procedural guidance.