Eleid, Mackram F.

Objective The presence of aortic paravalvular leak (PVL) is associated with lower survival, but a direct comparison of its impact after transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) has not been performed. This study sought to determine the differential influence of PVL on survival following TAVR versus SAVR and in patients with varying levels of risk as defined by the Society of Thoracic Surgeons (STS) risk score. Methods Patients with and without postprocedural PVL were identified from 2290 patients undergoing TAVR or SAVR at Mayo Clinic between 2008 and 2014. The primary endpoint was overall survival. Results There were 588 patients with PVL (374 TAVR, 214 SAVR): age 78±11 years, 63% male and mean follow-up of 3±2 years. PVL was trivial/mild in 442 (75%) patients. In propensity-matched analyses (n=86 per group), the overall survival at 1 and 4 years was 93% and 56% vs 89% and 61% in patients with PVL after TAVR versus SAVR, respectively (p=0.43). The presence or degree of PVL severity had no influence on survival of patients with high STS score (≥8%), while the presence of greater than mild PVL predicted worse survival in those with STS score <8%. During the first year after PVL diagnosis, while either improvement or stable PVL grade was seen in the majority of patients, worsening of PVL grade was more common in the TAVR group (19%) versus the SAVR group (4%) (p<0.0001). Conclusions At mid-term follow-up, the presence of PVL was associated with equally unfavourable outcomes following SAVR or TAVR. In patients with high STS risk score, the presence of PVL was not independently associated with increased mortality.

AbstractObjectivesThis study reports long‐term outcomes percutaneous Melody valve (Medtronic, Minneapolis, Minnesota) valve‐in‐valve therapy in patients with prosthetic valve dysfunction.BackgroundRepeat valve surgery is associated with high morbidity and mortality. Transcatheter mitral valve‐in‐valve is a promising alternative in patients at high‐risk for cardiac surgery.MethodsWe conducted a retrospective cohort analysis of 13 patients who underwent Melody valve‐in‐valve for bioprosthetic dysfunction from July 2011 to October 2013.ResultsMean age was 74.4 years, 46% male, and STS score 13.5 ± 6.8%. All patients had NYHA class 3 or 4 symptoms with improvement to class 1 or 2 in 82% post procedure. Median follow‐up was 4.5 years with longest follow‐up of 5.5 years. Thirty‐day mortality was 15.4% with 1‐year mortality of 25% and no other reported deaths until 4.5 years. 76.9% of patients had mitral gradient of 5 mmHg or less immediately postprocedure. One patient required repeat valve procedure for structural deterioration at 4.4 years. At 1, 3, and 5 year follow‐ups 75% of patients were NYHA class 1 or 2, mean gradients were 4.5 ± 0.6, 6.8 ± 0.5, and 7.5 ± 0.7, respectively. Using 4‐point scale, mitral regurgitation postprocedure was 0.8 ± 0.6. At 1, 3, and 5 years this increased to 1.0 ± 1.1, 1.3 ± 1.3, and 2.5 ± 2.1, respectively.ConclusionsMelody valve‐in‐valve therapy was effective with 1‐year symptomatic improvement. Prosthesis deterioration requiring repeat intervention was observed in one patient. Larger cohorts with multicenter registries are needed to determine the role of this percutaneous valve‐in‐valve therapy as valve technology and procedural techniques improve.

AbstractObjectiveTo study the effect of percutaneous paravalvular leak closure on hemolysis.BackgroundAlthough transcatheter PVL closure reduces heart failure and mortality in symptomatic patients with paravalvular leaks (PVL), little is known about its effect on hemolysis.MethodsWe retrospectively analyzed patients undergoing transcatheter mitral or aortic PVL closure (January 2005–December 2016) at Mayo Clinic. Patients with anemia or abnormal hemolysis markers (LDH, haptoglobin) were included in the analysis. The primary outcome was defined as hemoglobin increase ≥ 1.5 mg/dL, decrease in LDH above median or improvement in haptoglobin. Univariate and multivariate binary logistic regression modeling were used to determine predictors of successful treatment of hemolysis.ResultsFinal study population included 168 patients (130 [77%] mitral, 38 [23%] aortic PVL). Primary outcome occurred in 70 patients (42%). Hemoglobin increased by 1.74 ± 1.69 mg/dL in patients who reached primary outcome. 57/168 (34%) patients required blood transfusion prior to PVL closure compared to 35/168 (21%) postprocedure. The mean reduction in LDH was 403 U/L. Multivariate regression showed that patients with mechanical valves were more likely to have successful outcome (P = 0.044).ConclusionPercutaneous PVL closure is associated with modest improvement in hemolysis markers, increase in hemoglobin levels and reduction in blood transfusion requirements. This benefit is most significant in patients with mechanical valves.

AbstractBackgroundMitraClip is an effective transcatheter therapy for mitral regurgitation (MR). However, MitraClip is challenging in commissural MR and the optimal therapeutic approach is unclear.MethodsWe describe a case series of six consecutive patients with severe commissural primary mitral regurgitation who underwent MitraClip insertion followed by an Amplatzer Vascular Plug (AVP) II occluder between the commissure and the MitraClip.ResultsThe procedure was successful in all patients. MR was reduced from severe to mild/trivial in 50% and moderate in 50% of cases. On 30‐day follow‐up, NYHA class had improved from III (6 patients) to I (2 patients), II (2 patients), and III (2 patients). The mean transmitral gradient was 2.5 ± 1.8 mmHg at baseline and 4.8 ± 2.6 mmHg following the procedure. One patient developed hemolysis immediately post procedure. The other five patients remained well during a median follow‐up of 20 months (range 5–50 months) with no reported device dislodgement.ConclusionsElective treatment of severe commissural MR with a laterally or medially placed MitraClip coupled with an AVP II occluder between the clip and the commissure is feasible and safe. This approach may provide a useful management alternative in selected patients.

Background: There are contrasting reports on the effectiveness of a concomitant intra-aortic balloon pump (IABP) in cardiogenic shock patients treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO). This study sought to compare short-term mortality in patients with cardiogenic shock treated with VA-ECMO with and without IABP. Methods and Results: We reviewed the published literature from 2000 to 2018 for studies evaluating adult patients requiring VA-ECMO for cardiogenic shock with concomitant IABP. Studies reporting short-term mortality were included. Meta-analysis of the association of IABP with mortality was performed using Mantel-Haenszel models. Subgroup analyses were performed in patients with cardiogenic shock complicating acute myocardial infarction (AMI) and postcardiotomy cardiogenic shock. Twenty-two observational studies with 4653 patients were included. These studies showed high heterogeneity for the total and postcardiotomy cardiogenic shock cohorts and low heterogeneity for the AMI cohort. Short-term mortality was not significantly different in patients with and without IABP 42.1% versus 57.8%; risk ratio, 0.80; 95% CI, 0.52–1.22; P =0.30. However, concomitant IABP with VA-ECMO was associated with lower mortality in patients with AMI (50.8% versus 62.4%; risk ratio, 0.56; 95% CI, 0.46–0.67; P <0.001). There was no difference in mortality in postcardiotomy cardiogenic shock and mixed causes for cardiogenic shock. Conclusions: In cardiogenic shock patients requiring VA-ECMO support, the use of IABP did not influence mortality in the total cohort. In patients with AMI, use of IABP with VA-ECMO was associated with 18.5% lower mortality in comparison to patients on VA-ECMO alone. Further randomized studies are warranted to corroborate these observational data.

Background: Risks and mechanisms of extension of conservatively managed spontaneous coronary artery dissection (SCAD) remain incompletely understood. Study objectives were to (1) evaluate mechanisms of early SCAD evolution through serial angiographic analysis, and (2) determine predictors of early SCAD progression. Methods and Results: Retrospective registry study of patients with SCAD managed with an initial conservative strategy (n=240). Patients who experienced significant SCAD progression within 14 days, defined as clinical worsening plus new critical coronary obstruction on repeat angiography, were compared with remaining controls. A total of 42 of 240 (17.5%) experienced significant SCAD progression after index conservative approach; 91% by day 6. Isolated intramural hematoma (IMH) at baseline (no intimal dissection) was observed more frequently in those experiencing progression compared with controls (69.1% versus 44.4%; P =0.004). Multivariable predictors of SCAD progression included lesion severity, multivessel involvement, and isolated IMH. To investigate mechanisms of SCAD evolution, all repeat angiograms ≤14 days were compared with corresponding baselines (n=82 patient angiogram pairs). Of those with isolated IMH at baseline, 20% developed intimal dissection at repeat study. IMH was associated with greater longitudinal lesion extension (11.5 versus 2.8 mm; P =0.01), worsening Thrombolysis in Myocardial Infarction flow (−0.8 versus 0.1; P =0.003), and a nonsignificant lower rate of angiographic improvement (20.0% versus 31.3%; P =0.16) compared with the group with baseline intimal dissection. Optical coherence tomography subgroup analysis (n=17) indicated intimo-medial thickness to be lowest at the midpoint of IMH. Conclusions: Conservatively managed SCAD carries a 1:6 hazard for serious deterioration within 6 days. The risk was higher in those with isolated IMH at baseline. IMH often precedes development of intimal dissection, which has implications for mechanisms of SCAD.

AbstractObjectivesTo measure the intraprocedural change in left atrial pressure (LAP) with saline administration during transcatheter mitral valve repair (TMVR).BackgroundTMVR with MitraClip offers an alternative to surgery in select patients. During this procedure, large volumes of fluid are routinely administered with anesthesia and to facilitate transcatheter valve repair. LAP, a measure used to guide repair, may thereby change as a result of volume expansion, suggesting a need for continuous intracardiac pressure monitoring.MethodsConsecutive patients with severe mitral regurgitation underwent TMVR with MitraClip and continuous LAP monitoring through a dedicated sampling catheter. Specific LAP values were acquired immediately after transseptal access; before first clip deployment; and after deployment of the last clip.Results151 patients (age 80 ± 8 years, 64% male) underwent TMVR with MitraClip and continuous LAP monitoring. Mean LAP and v‐wave pressure increased significantly from baseline to pre‐MitraClip deployment (P < 0.0001) and decreased significantly from deployment to procedure end (P < 0.0001). Linear regression of v‐wave pressure change (from procedure start to clip deployment) relative to volume administration yielded a significantly nonzero slope (0.28 mmHg/min, P < 0.0001, r = 0.30).ConclusionFluid administration during TMVR leads to time‐dependent increases in LAP. Such intraprocedural change underscores the need for targeted, if not continuous, LAP measurement during TMVR to optimize MitraClip placement and mitral regurgitation reduction.

Background There are limited data on the use of venoarterial extracorporeal membrane oxygenation ( VA ‐ ECMO ) or cardiopulmonary bypass ( CPB ) to provide hemodynamic support periprocedurally during transcatheter aortic valve replacement. This study sought to evaluate patients receiving transcatheter aortic valve replacement with concomitant use of CPB / VA ‐ ECMO . Methods and Results We systematically reviewed the published literature from 2000 to 2018 for studies evaluating adult patients requiring CPB / VA ‐ ECMO periprocedurally during transcatheter aortic valve replacement. Studies reporting short‐term and long‐term mortality were included. Given the significant methodological and statistical differences between published studies, meta‐analysis of the association of CPB / VA ‐ ECMO with mortality was not performed. Of the 537 studies identified, 9 studies representing 5191 patients met our inclusion criteria. Median ages were between 75 and 87 years with 33% to 75% male patients. Where reported, the Edwards SAPIEN ™ transcatheter heart valve was the most frequently used. A total of 203 (3.9%) patients received periprocedural hemodynamic support with CPB / VA ‐ ECMO . Common indications for CPB / VA ‐ ECMO included left ventricular or aortic annular rupture, rapid hemodynamic deterioration, aortic regurgitation, cardiac arrest, and left main coronary artery obstruction. The use of CPB / VA ‐ ECMO was predominantly an emergent strategy and was used for durations of 1 to 2 hours. Short‐term mortality (in‐hospital and 30‐day) was 29.8%, and 1‐year mortality was 52.4%. Major complications such as bleeding, vascular injury, tamponade, stroke, and renal failure were noted in 10% to 50% of patients. Conclusions CPB / VA ‐ ECMO was used in 4% in the early experience of patients undergoing transcatheter aortic valve replacement, most commonly for periprocedural complications. There are limited data on preprocedural planned use of VA ‐ ECMO , and the characteristics of this population remain poorly defined.