1-Year Outcomes of Transcatheter Edge-to-Edge Repair in Anatomically Complex Degenerative Mitral Regurgitation Patients.

BACKGROUND: Favorable 6-month outcomes from the CLASP IID Registry (Edwards PASCAL transcatheter valve repair system pivotal clinical trial) demonstrated that mitral valve transcatheter edge-to-edge repair with the PASCAL transcatheter valve repair system is safe and beneficial for treating prohibitive surgical risk degenerative mitral regurgitation (DMR) patients with complex mitral valve anatomy. OBJECTIVES: The authors sought to assess 1-year safety, echocardiographic and clinical outcomes from the CLASP IID Registry. METHODS: Patients with 3+ or 4+ DMR who were at prohibitive surgical risk, had complex mitral valve anatomy based on the MitraClip Instructions for Use, and deemed suitable for treatment with the PASCAL system were enrolled prospectively. Safety, clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. Study oversight included a central screening committee, echocardiographic core laboratory, and clinical events committee. RESULTS: Ninety-eight patients were enrolled. One-year Kaplan-Meier (KM) estimates of freedom from composite major adverse events, all-cause mortality, and heart failure hospitalization were 83.5%, 89.3%, and 91.5%, respectively. Significant mitral regurgitation (MR) reduction was achieved at 1 year (P < 0.001 vs baseline) including 93.2% at MR ≤2+ and 57.6% at MR ≤1+ with improvements in related echocardiographic measures. NYHA functional class and Kansas City Cardiomyopathy Questionnaire score also improved significantly (P < 0.001 vs baseline). CONCLUSIONS: At 1 year, treatment with the PASCAL system demonstrated safety and significant MR reduction, with continued improvement in clinical, echocardiographic, functional, and quality-of-life outcomes, illustrating the value of the PASCAL system in the treatment of prohibitive surgical risk patients with 3+ or 4+ DMR and complex mitral valve anatomy.

Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation.

BACKGROUND: Mitral valve transcatheter edge-to-edge repair is safe and effective in treating degenerative mitral regurgitation (DMR) patients at prohibitive surgical risk, but outcomes in complex mitral valve anatomy patients vary. OBJECTIVES: The PASCAL IID registry assessed safety, echocardiographic, and clinical outcomes with the PASCAL system in prohibitive risk patients with significant symptomatic DMR and complex mitral valve anatomy. METHODS: Patients in the prospective, multicenter, single-arm registry had 3+ or 4+ DMR, were at prohibitive surgical risk, presented with complex anatomic features based on the MitraClip instructions for use, and were deemed suitable for the PASCAL system by a central screening committee. Enrolled patients were treated with the PASCAL system. Safety, effectiveness, and functional and quality-of-life outcomes were assessed. Study oversight also included an echocardiographic core laboratory and clinical events committee. RESULTS: The study enrolled 98 patients (37.2% ≥2 independent significant jets, 15.0% severe bileaflet/multi scallop prolapse, 13.3% mitral valve orifice area <4.0 cm2, and 10.6% large flail gap and/or large flail width). The implant success rate was 92.9%. The 30-day composite major adverse event rate was 11.2%. At 6 months, 92.4% patients achieved MR ≤2+ and 56.1% achieved MR ≤1+ (P < 0.001 vs baseline). The Kaplan-Meier estimates for survival, freedom from major adverse events, and heart failure hospitalization at 6 months were 93.7%, 85.6%, and 92.6%, respectively. Patients experienced significant symptomatic improvement compared with baseline (P < 0.001). CONCLUSIONS: The outcomes of the PASCAL IID registry establish the PASCAL system as a useful therapy for prohibitive surgical risk DMR patients with complex mitral valve anatomy. (PASCAL IID Registry within the Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID] NCT03706833).

Calcific Aortic Stenosis-A Review on Acquired Mechanisms of the Disease and Treatments.

Calcific aortic stenosis is a progressive disease that has become more prevalent in recent decades. Despite advances in research to uncover underlying biomechanisms, and development of new generations of prosthetic valves and replacement techniques, management of calcific aortic stenosis still comes with unresolved complications. In this review, we highlight underlying molecular mechanisms of acquired aortic stenosis calcification in relation to hemodynamics, complications related to the disease, diagnostic methods, and evolving treatment practices for calcific aortic stenosis.

Early outcomes from the CLASP IID trial roll-in cohort for prohibitive risk patients with degenerative mitral regurgitation.

OBJECTIVES: We report the 30-day outcomes from the roll-in cohort of the CLASP IID trial, representing the first procedures performed by each site. BACKGROUND: The currently enrolling CLASP IID/IIF pivotal trial is a multicenter, prospective, randomized trial assessing the safety and effectiveness of the PASCAL transcatheter valve repair system in patients with clinically significant MR. The trial allows for up to three roll-in patients per site. METHODS: Eligibility criteria were: DMR ≥3+, prohibitive surgical risk, and deemed suitable for transcatheter repair by the local heart team. Trial oversight included a central screening committee and echocardiographic core laboratory. The primary safety endpoint was a 30-day composite MAE: cardiovascular mortality, stroke, myocardial infarction (MI), new need for renal replacement therapy, severe bleeding, and non-elective mitral valve re-intervention, adjudicated by an independent clinical events committee. Thirty-day echocardiographic, functional, and quality of life outcomes were assessed. RESULTS: A total of 45 roll-in patients with mean age of 83 years and 69% in NYHA class III/IV were treated. Successful implantation was achieved in 100%. The 30-day composite MAE rate was 8.9% including one cardiovascular death (2.2%) due to severe bleeding from a hemorrhagic stroke, one MI, and no need for re-intervention. MR≤1+ was achieved in 73% and ≤2+ in 98% of patients. 89% of patients were in NYHA class I/II (p < .001) with improvements in 6MWD (30 m; p = .054) and KCCQ (17 points; p < .001). CONCLUSIONS: Early results representing sites with first experience with the PASCAL repair system showed favorable 30-day outcomes in patients with DMR≥3+ at prohibitive surgical risk.

Impact of intracoronary imaging on in-hospital mortality and 30-day readmission rates following percutaneous coronary intervention: A nationwide readmissions database analysis.

BACKGROUND: Percutaneous coronary intervention (PCI) is well established for the treatment of obstructive coronary artery disease. This study was performed to assess the impact of in-hospital mortality and 30-day readmission with intracoronary imaging as an adjunct to baseline coronary angiography. METHODS: The study was derived from the Healthcare Cost and Utilization Project's National Readmission Database (NRD) of 2016, sponsored by the Agency for Healthcare Research and Quality. Patients who underwent PCI were identified using appropriate ICD-10 codes. Study population was further subcategorized into 2 PCI arms: intravascular imaging (''imaging'' group) and fluoroscopy guided (''angiography'' group). Primary endpoints were 30-day readmissions and in-hospital mortality. Secondary endpoints were length of stay, cost of care, predictors of 30-day readmission and in-hospital mortality in PCI related hospitalizations. RESULTS: We identified in total 188,368 index admissions, with 12,379 patients in the "imaging-guided" group and 175,989 in the "angiography-alone" group. There were no differences in 30-day readmissions between both groups (~10.8% in both arms, p = .788). However, in-hospital mortality carried a statistically significant reduction with use of imaging-guided PCI (1.72% vs 2.24%, p = .004). The median length of stay was longer in the imaging-guided arm (3 vs. 2 days, p < .001), associated with larger median total hospital costs ($32,123 USD vs. $25,162 USD, p < .001). The strongest predictor of in-hospital mortality in both univariate and multivariate analysis was having an existing coagulopathy. CONCLUSION: The results of this study did not confer benefit with regards to 30-day hospital readmission rates when utilizing intracoronary imaging versus angiography-alone in percutaneous coronary intervention, but did suggest there may be an association between the use of intracoronary imaging and improved in-hospital mortality. In addition, resource utilization was higher in the intra-coronary imaging arm of the study.

Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement.

BACKGROUND: Bicuspid aortic stenosis accounts for almost 50% of patients undergoing surgical aortic valve replacement in the younger patients. Expanding the indication of transcatheter aortic valve replacement (TAVR) toward lower-risk and younger populations will lead to increased use of TAVR for patients with bicuspid aortic valve (BAV) stenosis despite the exclusion of bicuspid anatomy in all pivotal clinical trials. OBJECTIVES: This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices. METHODS: Patients with BAV confirmed by central core laboratory computed tomography (CT) analysis were included from the international multicenter BAV TAVR registry. BAV morphology including the number of raphe, calcification grade in raphe, and leaflet calcium volume were assessed with CT analysis in a masked fashion. Primary outcomes were all-cause mortality at 1 and 2 years, and secondary outcomes included 30-day major endpoints and procedural complications. RESULTS: A total of 1,034 CT-confirmed BAV patients with a mean age of 74.7 years and Society of Thoracic Surgeons score of 3.7% underwent TAVR with contemporary devices (n = 740 with Sapien 3; n = 188 with Evolut R/Pro; n = 106 with others). All-cause 30-day, 1-year, and 2-year mortality was 2.0%, 6.7%, and 12.5%, respectively. Multivariable analysis identified calcified raphe and excess leaflet calcification (defined as more than median calcium volume) as independent predictors of 2-year all-cause mortality. Both calcified raphe plus excess leaflet calcification were found in 269 patients (26.0%), and they had significantly higher 2-year all-cause mortality than those with 1 or none of these morphological features (25.7% vs. 9.5% vs. 5.9%; log-rank p < 0.001). Patients with both morphological features had higher rates of aortic root injury (p < 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016). CONCLUSIONS: Outcomes of TAVR in bicuspid aortic stenosis depend on valve morphology. Calcified raphe and excess leaflet calcification were associated with increased risk of procedural complications and midterm mortality. (Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry; NCT03836521).

Operator Experience and Outcomes after Transcatheter Left Atrial Appendage Occlusion with the Watchman Device.

BACKGROUND: Transcatheter left atrial appendage occlusion (LAAO) has become a suitable alternative to anticoagulation in patients with atrial fibrillation (AF). However, volume-outcome relationships at the individual operator level have not been studied. METHODS: Study population included 425 consecutive patients with AF undergoing LAAO from August 2015 to November 2018 by seven operators at BUMC-Phoenix. Operator volume was divided in tertiles by those with <40 cases/year (2 operators), 41-80 cases/year (3 operators) and >80 cases/year (2 operators). Patient data including comorbidities, labs, medications, procedural characteristics and outcomes were collected. The primary composite outcome was major adverse cardiac events (MACE) including mortality, stroke, bleeding and vascular complications. RESULTS: Mean age was 75 ±â€¯8 years and 251 (59%) were males. Mean CHA2DS2-VASc score was 4.5 ±â€¯1.3 points and mean HASBLED score was 3.9 ±â€¯1.0 points. MACE outcome was similar in the three operator groups in both unadjusted (p = 0.83) and adjusted (OR = 0.59: 95% Confidence Interval [CI]: 0.15-2.29, p = 0.45) analysis. The occurrence MACE was also similar between Interventional Cardiologist (IC) and Electrophysiologist (EP) operators in an unadjusted (p = 0.24) and adjusted (OR = 0.60: 95% CI: 0.21-1.68, p = 0.33) analysis. The secondary outcome of technical success did not differ among the three tertiles (p = 0.37) and among IC & EP operators respectively (p = 0.24) as well. CONCLUSION: Operator experience does not affect MACE and technical success even after adjusting for comorbidities. These results suggest a lower learning curve for LAAO with high technical success achievable even by low volume operators.

Severe takotsubo cardiomyopathy following orthotopic liver transplantation: A case series.

INTRODUCTION: Acute decompensated heart failure is a known complication following orthotopic liver transplant. Among those, there are some cases of takostubo type cardiomyopathy (TC), commonly referred to as "broken heart syndrome". While the exact mechanism of TC is unknown, it frequently proceeds a physical or emotional stressor. Here we present a series of seven cases of TC following orthotopic liver transplant. METHODS: A retrospective chart review was conducted on 454 patients were identified as having post-operative cardiac dysfunction in the setting of orthotopic liver transplantation. Of those, seven were identified as having TC based on apical ballooning, acute heart failure without evidence of coronary artery disease. All seven underwent pre-operative cardiac evaluation per protocol. Extensive chart review was performed on the seven patients to identify pre and post-operative qualities. RESULTS: At this single institution, TC affected 7/454 patients, reflecting an incidence of 1.5% over the eight year study period. Of the seven patients affected, one expired. Patients represented a mix of emergent and scheduled transplantation in the setting of end stage liver disease (ESLD). Patients had a mix of etiologies related to their ELSD including hepatitis C, alcoholic cirrhosis, and non-alcoholic steatohepatitis. DISCUSSION: It is important to recognize TC as a potential complication following liver transplantation so as to detect cases earlier in the disease course and begin early goal-directed care.

An updated meta-analysis of TAVR in patients at intermediate risk for SAVR.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has been approved for use in patients with severe aortic stenosis at intermediate, high and extreme surgical risk. This meta-analysis was performed to assess the safety and efficacy of TAVR compared to surgical aortic valve replacement (SAVR) in intermediate risk patients. METHODS: We searched PubMed, EMBASE, Web of science, and the Cochrane Central Register of Controlled Trials databases for studies comparing TAVR versus SAVR in patients at intermediate surgical risk, with a mean Society of Thoracic Surgeon score of 3-8% or a mean logistic European risk score of 10-20%. The primary endpoint was to assess the efficacy of TAVR compared to SAVR, defined as all-cause and cardiovascular mortality at 30-days, 1-year, and ≥2 years of follow-up. Secondary endpoints were the safety profile, comprising of cerebrovascular events, myocardial infarctions, permanent pacemaker placement, new onset atrial fibrillation, aortic regurgitation, vascular complications, major bleeding and acute kidney injury. RESULTS: This is the largest and most contemporary meta-analysis of 5647 intermediate risk patients in eleven studies published to date. There were no statistically significant differences in all-cause and cardiac mortality at 30 days, 1- year and >2-years of follow up. Acute kidney injury and atrial fibrillation occurred more frequently in patients treated with SAVR and permanent pacemaker implantation and aortic insufficiency were more frequent in patients treated with TAVR. CONCLUSION: This meta-analysis suggests that for intermediate risk patients with severe aortic stenosis, TAVR has similar efficacy as SAVR but with a different adverse event profile.

Left atrial hemodynamics and left ventricular remodeling -predictors of outcomes after Transcatheter mitral valve repair with the MitraClip device.

BACKGROUND: Increased afterload and reduced left ventricular (LV) performance are sequela of mitral valve repair. However, hemodynamic left atrial and ventricular parameters that can predict outcome following mitral valve repair remain elusive. METHODS: One hundred and two consecutive patients undergoing MitraClip procedure from 2014 to 2017 at Banner University Medical Center were enrolled in this study. All patients underwent pre-procedure echocardiograms and intra-procedure invasive left atrial (LA) pressure monitoring. Clinical, laboratory, and procedural parameters were collected. The primary end-point was the composite outcome of all-cause mortality and repeat hospitalization within 90 days. RESULTS: The mean age was 77 ±10 years, the majority were Caucasians (93, 91.2%) and 47 (46.1%) were males. Thirty-two patients (31.4%) had diabetes, 39 (38.2%) had renal insufficiency, and 38 (37.3%) had a history of congestive heart failure. The median society of thoracic surgeons score was 6.7% (Interquartile range [IQR]: 3.9, 10.2). Immediately post-procedure there was a significant reduction in the LA pressure (Mean 12.0 vs. 18.6 mmHg, P < 0.001) and pulmonary artery systolic pressure (43.5 vs. 53.2 mmHg, P = 0.001) compared to baseline. LA pressure was an independent predictor of the composite outcome in an unadjusted (OR = 1.07, 95% CI: 1.00-1.13, P = 0.03) and adjusted (OR = 1.07, 95% CI: 1.00-1.14, P = 0.03) analysis respectively. CONCLUSION: LA pressure drop is an independent predictor of outcome after the MitraClip procedure. This finding has implications for early identification of patients at risk of poor outcomes and instituting aggressive medical therapy and close follow-up for avoiding hospitalizations for heart failure decompensation.

Permanent pacemaker implantation and paravalvular leak rates following sutureless aortic valve operations.

BACKGROUND: Permanent pacemaker (PPM) implantation and paravalvular leak (PVL) rates after sutureless aortic valve replacement (SuAVR) vary widely. The aim of this meta-analysis was to examine the incidence of new PPM implantation and PVL after SuAVR. METHODS: Studies evaluating PPM implantation and PVL rates after SuAVR were searched in Medline/PubMed, Ovid Journals, Clinicaltrials.gov, Cochrane central register of controlled trials and database. Studies with a sample size ≥10 were included in this analysis. Pooled proportions were calculated using both the fixed and random-effects models. The heterogeneity among studies was tested using I2 statistic. The study design was written in accordance with PRISMA guidelines. RESULTS: Thirty studies involving 3993 patients with a median follow-up of 12 months were included. The median age was 77 years and males constituted 50%. There was a history of stroke and coronary artery disease in 6% and 31% of the population. Pooled proportions demonstrate a cumulative postoperative PPM rate of 8.5% (95% confidence interval [CI] 7.6-9.5%, I2 = 68.8%) and the overall rate of any PVL was 4.2% (95%CI 3.4-5%, I2 = 76.1%) across all major SuAVR devices. The rate of severe PVL was only 0.4% (95%CI 0.2-0.7%, I2 = 0%) at discharge and 0.5% (95%CI 0.2-0.9%, I2 = 0%) at 12 months. CONCLUSIONS: In SuAVR prostheses implanted in this meta-analysis, the postoperative permanent pacemaker rate was higher (8.5%) than reported for non-SuAVR prosthesis. While the overall PVL rate was 4.2%, the incidence of severe PVL was only 0.4% at discharge and remained stable at 0.5% at 12 months.

Impella-assisted chronic total occlusion percutaneous coronary interventions: A multicenter retrospective analysis.

INTRODUCTION: Patients with coronary chronic total occlusions (CTO) often have concurrent higher-risk anatomy and physiology (significant calcium, left ventricular dysfunction, multivessel disease) that increase their procedural risk. We present a retrospective multicenter case series describing use of the Impella percutaneous ventricular assist device (p-VAD) during CTO PCI. METHODS: We performed a retrospective analysis of self-reported data from five large referral centers from 2013 to 2017 and identified patients that underwent elective, hemodynamically supported CTO PCI with the Impella p-VAD device (2.5 or CP). Preprocedural demographics, procedural invasive hemodynamics and characteristics, and in-hospital outcomes were reported. RESULTS: About 57 patients (2% of the overall CTO volume of these centers) were included in this retrospective cohort. The primary indication in the majority (78.9%) of cases was chronic angina; in 21.1% the primary indication was for chronic congestive heart failure because of an ischemic cardiomyopathy. The median LVEF was 20% (15%, 30%) and 63.2% were surgical turndowns. Significant proportions of the group underwent multivessel PCI (91.2%), intervention on an unprotected left main or last remaining conduit vessel (35.1%), and/or atherectomy (17.5%). Technical success was 87.7%. In-hospital procedural complications included: vascular injury (5.3%), all-cause death (5.3%), major bleeding (3.5%), stroke (1.8%), and coronary perforation resulting in tamponade (1.8%). CONCLUSION: Impella-assisted CTO PCI can be performed with high technical success rates. However, assiduous attention to appropriate case selection is critical, given the periprocedural complication rates reported in this patient population.

Rate-related left bundle branch block and cardiac memory in a patient with bradycardia: Case report and literature review.

Rate-related left bundle branch block (LBBB) is a well-studied phenomenon. Cardiac memory is another physiologic phenomenon in which T-wave abnormalities occur in the absence of ischemia. The association between these 2 phenomena has been described in several case reports. A literature review was performed through Ovid and PubMed, where at total of 93 cases of rate-related LBBB were identified. Cases were reviewed, and data were collected on rates of appearance and disappearance as well as the presence or absence of cardiac memory. There is some overlap in the rate at which LBBB appears. Cardiac memory is associated with rate-related LBBB in several cases, but its true prevalence is unknown. Cardiac memory is a phenomenon that is well described in the literature but is often underrecognized in clinical practice. As a consequence of overlooking this phenomenon and not including cardiac memory in the differential when T-wave abnormalities are observed, patients may be subjected to unnecessary invasive diagnostic testing.

Double Trouble: Transapical Transcatheter Replacement of the Aortic and Mitral Valves in a Single Operation.

This case represents the first reported simultaneous TAVR and TMVR for native aortic and mitral stenosis performed via the transapical approach.

An updated systematic review and meta-analysis of early outcomes after left atrial appendage occlusion.

BACKGROUND: Left atrial appendage occlusion (LAAO) is a promising intervention for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). Early outcomes following LAAO have been published in many studies with variable results. OBJECTIVE: This updated meta-analysis aims to provide a summary of the early outcomes of LAAO. METHODS: Medline/Pubmed, Ovid Journals, Clinical trials, Abstract meetings, Cochrane databases were searched from January 1st, 1999 to November 30th, 2016. RESULTS: This meta-analysis included 49 studies involving 12 415 patients. The median age was 73.5 years (IQR 72-75 years) and 43% were males. Hypertension and diabetes were present in 36% and 15% of the population, respectively. There was a prior history of stroke and congestive heart failure in 14% and 18% of the population, respectively. The median CHADS2 score was 2.9 (IQR 2.6-3.3) and the median HASBLED score was 3.3 (IQR 3-4). LAAO implantation was successful in 96.3% of patients (95.40-97.08, I2 = 76.1%). The pooled proportion of all-cause mortality was 0.28% (0.19-0.38, I2 = 0%). The pooled proportion of all-cause stroke was 0.31% (0.22-0.42, I2 = 9.4%), major bleeding requiring transfusion was 1.71% (1.13-2.41, I2 = 73.2%), and pericardial effusion was 3.25% (2.46-4.14, I2 = 79%). Sub analysis of randomized clinical trials comparing LAAO devices to warfarin showed lower mortality (P = 0.03) with similar bleeding risk (P = 0.20) with LAAO. CONCLUSIONS: This meta-analysis concludes that LAAO occlusion is a safe and effective stroke prevention strategy in patients with NVAF.

Impact of aortic aneurysms in trans-catheter aortic valve replacement: A single center experience.

BACKGROUND: Patients who undergo trans-catheter aortic valve replacement (TAVR) may have concomitant aortic aneurysms. We sought to clarify the incidence of aortic aneurysms and its impact on clinical outcomes among patients undergoing TAVR. METHODS: We performed a retrospective analysis of patients with severe symptomatic aortic stenosis who underwent TAVR from January 2012 to June 2016. Multi-detector computer tomography (MDCT) was performed on all patients and images were reviewed to identify thoracic and abdominal aortic aneurysms (TAA and AAA). The incidence of vascular complications (VARC-2 definition), and in-hospital and 6-month major adverse cardiac events (MACE) defined as a composite of all-cause mortality, cardiac arrest, myocardial infarction, and stroke were recorded. RESULTS: Among 232 patients included in the analysis, 22 patients (9.5%) had aortic aneurysms (11 had AAA, 8 had TAA, and 3 had both). Patients with aortic aneurysms had a higher, albeit statistically insignificant, rate of smoking history (63.6% vs. 42.9%, p = 0.062). Both groups of patient predominantly underwent TAVR via trans-femoral access (72.7% vs. 71.4%, p = 0.90). The incidence of vascular complications was similar between the two groups (9.1% vs. 10.5%, p = 1.0). Patients with aortic aneurysms had a similar in-hospital MACE (4.5% vs. 6.2%, p = 1.0) and 6-month MACE (9.1% vs. 9.0%, p = 1.0) compared to those without aneurysms. CONCLUSIONS: In our patient cohort, 9.5% of patients who underwent TAVR had concomitant aortic aneurysms. Patients with aortic aneurysms had similar incidence of vascular complications as well as in-hospital and 6-month MACE compared to those without.

Volume-outcome relationships for transcatheter aortic valve replacement-risk-adjusted and volume stratified analysis of TAVR outcomes.

OBJECTIVES: This purpose of the study was to evaluate TAVR outcomes at low, intermediate and high volume institutions. BACKGROUND: For the care of complex patients, volume-outcome effect is well described. The initial US TAVR experience was limited to a few centers of excellence. The impact of institutional volume on outcomes after TAVR has not been systematically studied. METHODS: Within the Banner Health system, TAVR is performed at 3 institutions-a low volume, an intermediate volume and a high volume institution. 181 consecutive patients undergoing TAVR within these 3 institutions were the study cohort. To adjust for bias and confounders between the 3 groups, risk-adjusted multivariate logistic regression and propensity score analysis was performed. The primary endpoint was a composite of mortality, dialysis-dependent renal failure, cerebrovascular accident, need for new permanent pacemaker and readmission within 30days. RESULTS: The primary endpoint was reached in 38.8% of patients at the high volume institution and 76.2% of patients at the low volume institution (p<0.01). Having a TAVR procedure at a larger volume institution was an independent predictor of having improved outcomes (OR 0.33, 95% CI 0.16-0.68; p=0.003). These improved outcomes after the TAVR procedure noted at the large volume institution were seen in the most complex patients: age ≥80years, BMI >30, diabetes, hypertension, prior CAD, CKD and NYHA class III/IV heart failure. CONCLUSIONS: High-risk patients undergoing TAVR at a large volume institution have better 30-day outcomes compared to outcomes at intermediate and low volume centers.

A retrospective analysis of Impella use in all-comers: 1-year outcomes.

BACKGROUND: There are non-randomized data about the benefits of Impella use in the setting of cardiogenic shock. However, limited data exist to help guide clinicians about whether in the context of the intervention the device should be implanted early or late; how long the device should stay in; and how the mode of explant should be. METHODS: This is a retrospective, single center registry over 5 years comparing in-hospital outcomes and 1-year mortality in all-comers who had the Impella device placed early versus those who had the device placed late as a bailout. The primary endpoint was a composite of in-hospital all-cause mortality, major vascular, bleeding complications, and stroke. A secondary endpoint was 1-year mortality. RESULTS: Of 262 total patients, 181 (69.1%) had early and 81 (30.9%) had late Impella placement. Patients in the early group had a lower combined MACCE (17.1% vs 59.3%, P < 0.001) and in-hospital mortality (8.8% vs 48.1%, P < 0.001) compared to the late group. Major vascular (3.3% vs 2.5%, P = 1.0), bleeding complications (5.0% vs 7.4%, P = 0.57), and stroke (3.3% vs 7.4%, P = 0.20) were not significant between groups. Early Impella placement had lower 6 month (17.7% vs 53.1%, P < 0.001) and 1-year mortality rates (21.5% vs 53.1%, P < 0.001) compared to those in the late group. CONCLUSION: For patients with need for an Impella device, regardless of the indication, early implantation is associated with better in-hospital and 1-year outcomes as compared to when the device is implanted late as a bailout.

Left atrial anatomy and patient-related factors associated with adverse outcomes with the watchman device-a real world experience.

OBJECTIVE: This study sought to identify patient and left atrial morphology specific factors associated with early complications for left atrial appendage occlusion with the Watchman™ (Boston Scientific, Natick, MA) device. BACKGROUND: Oral anticoagulation (OAC) is recommended for patients with atrial fibrillation, however, long-term OAC compliance is poor. In randomized control trials, the Watchman™ device has demonstrated superiority over OAC with warfarin for all cause and cardiovascular mortality and hemorrhagic stroke. However, predictors of procedural complications have not yet been well established. METHODS: There were 137 patients included in this study from a total of 141 consecutive patients prospectively enrolled in the registry between 8/1/2015 and 08/31/2016. Unadjusted, multivariate cox proportional hazards model was used for analysis. Primary end-point was a composite major adverse cardiac and cerebrovascular event (MACCE) defined to include death, stroke, major and life threatening bleeding, major vascular complications, device embolization, need for cardiovascular surgery, need for cardiopulmonary resuscitation, and significant pericardial effusion. RESULTS: The primary endpoint was reached in 5.8% of patients. There were no device embolization and no strokes. Anterior chicken morphology (ACW) of the left atrial appendage (LAA) conferred a hazard ratio of 3.7 for MACCE and a body mass index >30 kg/m2 significantly lowered the likelihood of a MACCE. CONCLUSION: Certain LAA morphologies and patient characteristics increase the risk for a MACCE following left atrial appendage occlusion (LAAO) with the Watchman™ device. Anterior chicken wing morphology of the LAA and low BMI <30 kg/m2 were independent predictors of MACCE in the multivariate regression model.