Impact of mitral intervention on outcomes of patients with mitral valve dysfunction and annulus calcification.

OBJECTIVES: To compare all-cause mortality in patients with mitral annulus calcification (MAC) and severe mitral valve dysfunction (MVD) who received standard mitral intervention versus no intervention. BACKGROUND: Patients with MAC often have high surgical risk due to advanced age, comorbidities, and technical challenges related to calcium. The impact of a mitral intervention on outcomes of patients with MAC and severe MVD is not well known. METHODS: Retrospective review of patients with MAC by transthoracic echocardiography (TTE) in 2015 at a single institution. Patients with severe mitral stenosis (MS) or regurgitation (MR) were analyzed and stratified into two groups: surgical or transcatheter intervention performed <1 year after the index TTE, and no or later intervention. The primary endpoint was all-cause mortality. RESULTS: Of 5502 patients with MAC, 357 had severe MVD (MS = 27%, MR = 73%). Of those, 108 underwent mitral intervention (surgery = 87; transcatheter = 21). They were younger (73 ± 11 vs. 76 ± 11 years, p < 0.01) and less frequently had cardiovascular diseases compared with no-intervention. Frequency in women was similar (45% vs. 50%, p = 0.44). During median follow-up of 3.2 years, the intervention group had higher estimated survival than those without intervention (80% vs. 72% at 1 year and 55% vs. 35% at 4 year, p < 0.01). Adjusted for age, eGFR, LVEF < 50%, and pulmonary hypertension, mitral intervention was an independent predictor of lower mortality (hazard ratio = 0.66, 95% confidence interval 0.43-0.99, p = 0.046). CONCLUSION: Patients with MAC and severe MVD who underwent mitral intervention <1 year from index TTE had lower mortality than those without intervention. Mitral intervention was independently associated with lower mortality.

Atrial mitral regurgitation: Characteristics and outcomes of transcatheter mitral valve edge-to-edge repair.

BACKGROUND: Mitral transcatheter edge-to-edge repair (MTEER) is an established therapeutic approach for mitral regurgitation (MR). Functional mitral regurgitation originating from atrial myopathy (A-FMR) has been described. OBJECTIVES: We sought to assess the clinical, echocardiographic and hemodynamic considerations in A-FMR patients undergoing MTEER. METHODS: From 2014 to 2020, patients undergoing MTEER for degenerative MR (DMR), functional MR (FMR), and mixed MR were assessed. A-FMR was defined by the presence of MR > moderate in severity; left ventricular (LV) ejection fraction (LVEF) ≥ 50%; and severe left atrial (LA) enlargement in the absence of LV dysfunction, leaflet pathology, or LV tethering. The diagnosis of A-FMR (vs. ventricular-FMR [V-FMR]) was confirmed by three independent echocardiographers. Baseline characteristics, procedural outcomes as well as clinical and echocardiographic follow-up are reported. Device success was defined as final MR grade ≤ moderate; MR reduction ≥1 grade; and final transmitral gradient <5 mmHg. RESULTS: 306 patients underwent MTEER, including DMR (62%), FMR (19%), and mixed MR (19%). FMR cases included 37 (63.8%) V-FMR and 21 (36.2%) A-FMR. Tricuspid regurgitation (≥ moderate) was higher in A-FMR (80.1%) compared to V-FMR (54%) and DMR (42%). Device success did not significantly differ between A-FMR and V-FMR (57% vs. 73%, p = 0.34) or DMR (57% vs. 64%, p = 1.0). The A-FMR cohort was less likely to achieve ≥3 grades of MR reduction compared to V-FMR (19% vs. 54%, p = 0.01) and DMR (19% vs. 49.7%, p = 0.01). Patients with V-FMR and DMR demonstrated significant reductions in mean left atrial pressure (LAP) and peak LA V-wave, though A-FMR did not (LAP -0.24 ± 4.9, p = 0.83; peak V-wave -1.76 ± 9.1, p = 0.39). In follow-up, echocardiographic and clinical outcomes were similar. CONCLUSIONS: In patients undergoing MTEER, A-FMR represents one-third of FMR cases. A-FMR demonstrates similar procedural success but blunted acute hemodynamic responses compared with DMR and V-FMR following MTEER. Dedicated studies specifically considering A-FMR are needed to discern the optimal therapeutic approaches.

Clinical predictors and impact of postoperative mean gradient on outcome after transcatheter edge-to-edge mitral valve repair.

BACKGROUND: The predictors and clinical significance of increased Doppler-derived mean diastolic gradient (MG) following transcatheter edge-to-edge mitral valve repair (MVTEER) remain controversial. OBJECTIVE: We sought to examine baseline correlates of Doppler-derived increased MG post-MVTEER and its impact on intermediate-term outcomes. METHODS: Patients undergoing MVTEER were analyzed retrospectively. Post-MVTEER increased MG was defined as >5 mmHg or aborted clip implantation due to increased MG intraprocedurally. Baseline MG and 3D-guided mitral valve area (MVA) by planimetry were retrospectively available in 233 and 109 patients. RESULTS: 243 patients were included; 62 (26%) had MG > 5 mmHg post-MVTEER or aborted clip insertion, including 7 (11%) that had aborted clip implantation. Mortality occurred in 63 (26%) during a median follow up of 516 days (IQR 211, 1021). Increased post-MVTEER MG occurred more frequently in females (44% vs. 16%, p < 0.001), those with baseline MVA <4.0 cm2 (71% vs. 16%), baseline MG ≥4 mmHg (61% vs. 20%), or multiple clips implanted (33% vs. 21%, p = 0.04). Increased post-MVTEER MG was associated with increased subsequent mortality compared to those with normal gradient (HR 1.91 95% CI 1.15-3.18 p = 0.016) as was aborted clip insertion compared to all others (HR 5.23 95% CI 2.06-13.28 p < 0.001). CONCLUSIONS: Smaller baseline MVA and increased baseline MG are associated with increased MG post-MVTEER and patients with a Doppler-derived post-MVTEER MG >5 mmHg suffered excess subsequent mortality. In high risk patients considered for MVTEER, identification of those at risk of iatrogenic mitral stenosis with MVTEER is important as they may be optimally treated with alternate surgical or transcatheter therapies.

Diastolic blood pressure predicts outcomes after aortic paravalvular leak closure.

OBJECTIVES: We sought to determine hemodynamic effects of aortic paravalvular leak (PVL) and predictors of clinical outcomes after aortic PVL closure. BACKGROUND: The significance of hemodynamic alterations in PVL and relation to severity, procedural success of percutaneous closure and clinical outcomes have not been defined. METHODS: Patients undergoing percutaneous PVL closure between July 21, 2004 and September 10, 2018 were included. PVL severity was assessed by echocardiography and aortic angiography. Hemodynamics were assessed by intra-arterial pressure tracings before and after PVL closure. The primary outcome was a composite of mortality, redo aortic valve replacement (AVR) and redo PVL closure. RESULTS: One hundred and seventeen patients (mean age 70.3 ± 14.9 years, 79% surgical and 21% transcatheter prostheses) underwent PVL closure with 94% technical success. PVL was moderate or greater in 106 (91%) at baseline and 11 (11%) post-procedure. Diastolic BP for those with moderate or greater PVL was lower than for those with less PVL (50.3 ± 11.7 vs. 56.5 ± 12.4 mmHg, p < .001). Pulse pressure was similar between these groups (69.9 ± 20.3 vs. 67.4 ± 21.2 mmHg, p = .39). 35 patients (34%) had 40 events during a mean follow-up of 1.6 ± 1.9 years (23 deaths, 12 redo AVR, and five redo PVL closures). In a multivariate model, final diastolic BP <47 mmHg (HR 3.27 [1.45-7.36], p = .007) was a significant predictor of the composite endpoint. CONCLUSIONS: Diastolic BP was significantly associated with aortic PVL severity and clinical outcomes after PVL closure. In contrast, pulse pressure did not correlate with PVL severity or outcomes. These findings have implications for clinical management of patients with aortic PVL.

Institutional learning experience for combined edge-to-edge tricuspid and mitral valve repair.

BACKGROUND: Transcatheter edge-to-edge repair with MitraClip is only approved for treatment of mitral regurgitation but is increasingly used to treat concomitant tricuspid regurgitation (TR) due to its common coexistence and association with poor outcomes. This study aimed to describe the learning curve associated with the challenge of off-label treatment of concomitant TR. METHODS: This is a retrospective review of initial and consecutive patients who underwent combined edge-to-edge repair of mitral and tricuspid valves (TVs) at our institution from August 2017 to October 2019. RESULTS: Repair of both valves with MitraClip was performed in 22 patients (median age 81.5 years, 32% female). Mean procedure time was 176 ± 47 min; mean fluoroscopy time was 65 ± 24 min. Procedure duration in the first tertile was significantly longer (223 ± 13 min) than in the third tertile (143 ± 23 min, p = .0003). Median number of total clips placed per case was 3; in 15 patients (68%), the anterior and septal leaflets of the TV were clipped. The average changes in mean right atrial (RA) and left atrial (LA) pressures were -1.7 ± 2.5 mmHg (p = .0080) and -3.2 ± 4.6 mmHg (p = .0045), respectively. The average changes in RA and LA V-wave heights were -3.3 ± 4.0 mmHg (p = .0009) and -8.1 ± 9.9 mmHg (p = .038), respectively. There was a significant trend toward decreasing residual TR over the course of the series (p = .046). At 30 days, survival was 100% and mean NYHA class decreased from 2.8 to 1.8 (p < .0001). CONCLUSIONS: Combined edge-to-edge tricuspid and mitral valve repair is safe and feasible. With experience, procedure duration and residual TR decreased.

Temporary balloon occlusion of atrial septal defects in suspected or documented left ventricular diastolic dysfunction: Hemodynamic and clinical findings.

OBJECTIVE: To review our experience with balloon testing prior to atrial septal defect (ASD) closure in adults with left ventricular (LV) diastolic dysfunction. BACKGROUND: ASD closure in patients with LV diastolic dysfunction may precipitate LV failure. Temporary ASD occlusion has been used in this scenario but data are limited. METHODS: Retrospective review of 27 patients age ≥ 50 years undergoing temporary ASD balloon occlusion between 2000 and 2018 for suspected LV diastolic dysfunction or elevated LV end-diastolic pressure (LVEDP). RESULTS: Median age was 72 years (IQR 66.7; 75.2). Atrial fibrillation was seen in 58% of patients, hypertension in 58%, and coronary artery disease in 26%; 52% were females. Median ASD size was 13 mm (10; 18) and Qp/Qs 1.8 (1.6; 2.2). Median LVEDP was 14 mmHg (12; 22); pulmonary artery wedge pressure (PAWP) 12 mmHg (9; 16.5) and left atrial pressure (LAP) 13.5 mmHg (8; 16.3). After a median of 5 min (3; 10) of balloon occlusion, patients with baseline LVEDP ≥15 mmHg had more significant increases in LVEDP (9 [6; 12] vs. 2 mmHg [0.5; 5]; p = 0.03) and LAP/PAWP (10.5 [8.3; 16.3] vs. 1.5 mmHg [-1.5; 3]; p = 0.0003) than those with baseline LVEDP <15 mmHg. None of those with a baseline LVEDP <15 mmHg had a LAP/PAWP >15 mmHg during balloon testing compared to 92% of patients with a baseline LVEDP ≥15 mmHg. CONCLUSION: LVEDP might be used to predict LAP post-ASD closure. Comorbidities typically associated with LV diastolic dysfunction are common in these patients and should be considered in their management.

Left ventricular remodeling and function after transapical versus transfemoral transcatheter aortic valve replacement.

BACKGROUND: The effect of utilizing transapical (TA) access for transcatheter aortic valve replacement (TAVR) on cardiac function has not been well studied. AIMS: The aim of this retrospective study is to determine the direct effects of TA access for TAVR on myocardial function parameters and their correlation with 4-year survival. METHODS: Three hundred and thirty propensity matched patients, who underwent TAVR using Sapien valve (Edwards Lifesciences Corp, Irvine, CA) between February 15, 2012 and June 17, 2016 (115 TA and 115 transfemoral [TF] routes) were studied. The pre- and 1 month post-TAVR echocardiographic features of both groups were compared. The 4-year survival in both groups was analyzed. RESULTS: Baseline clinical characteristics, diastolic function parameters, left ventricular (LV) chamber size, and ejection fraction were similar between matched TA and TF groups. At 1 month following TAVR, there was a significant increase in stroke volume index (SVI) in both TA (mean increase 7 cm3 /m2 ; P = 0.03) and TF groups (mean increase 7 cm3 /m2 ; P < 0.001). Left ventricular ejection fraction (LVEF) significantly increased post TF TAVR (mean increase 2%; P = 0.008), but no significant increase was observed post TA TAVR (mean increase 1%; P = 0.27). Both groups had significant improvement in aortic valve (AV) hemodynamics post-TAVR (P < 0.001). Overall, there were no significant differences in the mean change of SVI, LVEF, or left ventricular end diastolic dimensions (LVEDDs) post TA versus TF TAVR. There was no significant difference in 4-year survival in the TF compared to TA group (49% vs 50%, P = 0.43). CONCLUSION: Both TA and TF TAVR were equally associated with favorable changes in LV SVI and AV hemodynamics in 30 days. TA TAVR patients had similar 4 year survival to propensity matched TF TAVR; therefore, TA TAVR remains an acceptable alternative access route in patients not amenable to TF TAVR.

A hybrid technique for treatment of commissural primary mitral regurgitation.

BACKGROUND: MitraClip is an effective transcatheter therapy for mitral regurgitation (MR). However, MitraClip is challenging in commissural MR and the optimal therapeutic approach is unclear. METHODS: We 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. RESULTS: The 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. CONCLUSIONS: Elective 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.

Effect of percutaneous paravalvular leak closure on hemolysis.

OBJECTIVE: To study the effect of percutaneous paravalvular leak closure on hemolysis. BACKGROUND: Although transcatheter PVL closure reduces heart failure and mortality in symptomatic patients with paravalvular leaks (PVL), little is known about its effect on hemolysis. METHODS: We 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. RESULTS: Final 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). CONCLUSION: Percutaneous 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.

Comparison of left atrial pressure monitoring with dedicated catheter versus steerable guiding catheter during transcatheter mitral valve repair.

OBJECTIVE: The objective of this study was to determine the accuracy of left atrial pressure (LAP) measurement through the manufacturer provided steerable guiding catheter (SGC) during transcatheter mitral valve repair (TMVR). BACKGROUND: LAP measurement during TMVR has been shown to be associated with clinical improvement when measured through a dedicated catheter. METHODS: Simultaneous LAP was performed in consecutive patients using an independent fluid-filled 4F multipurpose catheter and compared to LAP waveforms measured through the manufacturer-provided MitraClip SGC during TMVR (Abbott, Santa Clara, CA). RESULTS: Mean age of 10 consecutive subjects with primary mitral regurgitation undergoing TMVR was 83 ± 3 years (60% female). Left atrial v wave and mean pressures through the dedicated catheter were 42 ± 7 and 24 ± 3 mmHg vs. 35 ± 7 and 23 ± 3 mmHg through the SGC (P < 0.001 and P = 0.23, respectively). Mean differences in v wave and mean LAP were 8 ± 4 and 1.0 ± 2.4 mmHg (percent difference 19 and 3%), respectively. SGC waveform overdamping was observed in all cases. CONCLUSIONS: Left atrial v wave pressure measurement through a dedicated catheter with sideholes during TMVR has superior accuracy compared to the manufacturer provided SGC, which results in waveform overdamping and a significant underestimation of v wave pressure. These data have important implications for clinical practice.

Effect of saline administration on left atrial pressure during transcatheter mitral valve repair.

OBJECTIVES: To measure the intraprocedural change in left atrial pressure (LAP) with saline administration during transcatheter mitral valve repair (TMVR). BACKGROUND: TMVR 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. METHODS: Consecutive 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. RESULTS: 151 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). CONCLUSION: Fluid 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.

Procedural trends, outcomes, and readmission rates pre-and post-FDA approval for MitraClip from the National Readmission Database (2013-14).

BACKGROUND: There are sparse clinical data on the procedural trends, outcomes and readmission rates following FDA approval and expansion of Transcatheter mitral valve repair/MitraClip® . Whether a complex new technology can be disseminated safely and quickly is controversial. METHODS: The study cohort was derived from the National Readmission Data (NRD) 2013-14. MitraClip® was identified using appropriate International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes. The primary outcome was a composite of in-hospital mortality + procedural complications. Secondary outcome included 30-day readmissions. Hierarchical two level logistic models were used to evaluate study outcomes. RESULTS: Our analysis included 2003 MitraClip® procedures. Overall in-hospital mortality was 3.9%. As expected, there was a significant increase in procedural volume post-FDA approval. Importantly, a corresponding downward trend in mortality and procedural complications was observed. Significant predictors of in-hospital mortality and procedural complications included the use of vasopressors (P <0.001) and hemodynamic support (P < 0.001). Higher hospital volume (≥10 MitraClips/year) was associated with lower in-hospital mortality and complications (P = 0.02). There were 304 (15.1%) 30-day readmissions, with heart failure being the most common cause of readmission. Elective procedures had lower in-hospital mortality (P < 0.001) and lower readmission rates (P = 0.011) compared with nonelective procedures. CONCLUSION: A significant increase in MitraClip® procedural volumes occurred post-FDA approval. Overall morbidity and mortality were low and trended downwards. Hospital procedure volume ≥10 cases were associated with lower mortality and overall complication rates. These data suggest a successful roll out of a very complex novel structural heart procedure.

Techniques and outcomes of paravalvular leak repair after transcatheter aortic valve replacement.

OBJECTIVES: To investigate the feasibility, procedural success, and outcomes of paravalvular leak (PVL) closure in patients with prior transcatheter aortic valve replacement (TAVR). BACKGROUND: PVL after TAVR is associated with adverse patient outcomes and increased mortality. Percutaneous PVL closure has emerged as a therapeutic strategy for addressing this issue, but data for transcatheter PVL repair after TAVR remains limited. METHODS: This is a single center retrospective review of PVL closure after TAVR. Patients with balloon-expandable or self-expanding prostheses were included. Baseline patient demographics, procedural characteristics, complications, and clinical outcomes were reviewed. RESULTS: A total of 18 patients with clinically significant PVL after TAVR referred for PVL closure were identified during the study period. Procedural success resulting in successful transcatheter occluder plug delivery was 78% (14 cases). Balloon postdilatation (2/4) and valve-in-valve (2/4) were used effectively in the remaining patients after an unsuccessful PVL closure attempt. PVL grading by echocardiography decreased from moderate or severe to < moderate in 13 patients (72%). Adverse events including cardiac tamponade and acute kidney injury occurred in 1 case each. One-month all-cause mortality was 11%. CONCLUSION: In selected patients, percutaneous PVL repair following TAVR is feasible and effective for both balloon-expandable and self-expanding prostheses. Most patients undergoing PVL closure after TAVR require a single occluder plug placement for reduction in PVL to mild or less.

Acute invasive hemodynamic effects of percutaneous mitral paravalvular leak closure.

OBJECTIVES: The aim of this study was to demonstrate the physiologic effects of percutaneous mitral paravalvular leak (PVL) closure through pre- and post-closure left and right heart catheterization. BACKGROUND: Mitral PVL represents a significant source of morbidity and mortality following mitral valve repair and replacement. Although percutaneous PVL closure is an effective treatment with improvements in symptoms and mortality, data regarding the acute hemodynamic effects of such closure are lacking. METHODS: Consecutive patients with clinically significant heart failure and/or hemolysis attributed to mitral PVL underwent percutaneous mitral PVL closure with pre- and post-procedural right and left heart catheterization. Hemodynamic measurements of cardiovascular function obtained in this manner were compared and stratified according to pre- and post-procedural echocardiographic severity of PVL. RESULTS: Twenty-four patients (age 68 ± 9.4 years, 75% male) underwent percutaneous mitral PVL closure. Significant improvements were found in left atrial pressure (LAP) (mean LAP lowered from 21 ± 4 to 19 ± 3 mm Hg, P = 0.005), pulmonary artery pressure (PAP) (mean PAP lowered from 36 ± 11 to 33 ± 9, P = 0.04), and cardiac index (increased from 2.8 ± 0.8 to 3.0 ± 0.7 L/min/m2 , P = 0.01). Left atrial v-wave reduction of 20% was associated with ≤ mild residual PVL by transesophageal echocardiography (P = 0.09). CONCLUSIONS: Percutaneous mitral PVL closure is associated with significant reductions in LAP and PAP and an increase in cardiac index. These hemodynamic effects underlie the clinical benefits of PVL closure and may be a useful tool for intraprocedural guidance. © 2017 Wiley Periodicals, Inc.

Left atrial pressure and predictors of survival after percutaneous mitral paravalvular leak closure.

BACKGROUND: Data on the clinical utility of left atrial (LA) hemodynamic monitoring during percutaneous mitral interventions are limited. OBJECTIVES: To evaluate the association between intraprocedural LA pressures during percutaneous mitral paravalvular leak (PVL) closure and long term survival. METHODS: Patients who underwent mitral PVL repair with invasive LA pressure monitoring were divided at baseline to three tertiles based on their mean final LA pressure (<25%; 25-30%; >30% of mean systolic blood pressure). Primary outcome was all-cause mortality. RESULTS: 134 patients (mean age 68 ± 12 years) were studied. Over 3 year mean follow-up, 81 (38%) patients died. The cumulative probability of death at 3 years was significantly higher among patients in the highest LA pressure tertile (56 ± 8% vs. 28 ± 5%, log rank P < 0.001). More than mild residual mitral regurgitation (MR) by transesophageal echocardiography (TEE) was associated with a 2.5-fold increased risk of death and patients in the highest LA pressure tertile had 2.2-fold higher mortality (P < 0.001 and = 0.003 respectively). After adjustment for residual MR by TEE, each 10% acute procedural reduction in LA pressures was associated with a significant 9% reduced risk of death (P = 0.023). Multivariate Cox regression with adjustment for multiple predictors of death showed that patients in lower LA pressure tertiles had 59% lower mortality (P = 0.003). CONCLUSION: Lower LA pressure following mitral PVL closure is an independent predictor of improved survival, even after adjustment for residual MR. LA pressure monitoring may be a useful tool for procedural guidance during mitral PVL closure.

Long-term follow-up after PFO device closure: Outcomes and Complications in a Single-center Experience.

OBJECTIVES: To describe medium- to long-term follow-up of patients undergoing device closure of patent foramen ovale (PFO) for stroke or transient ischemic attack (TIA). BACKGROUND: Transcatheter device closure of PFO continues to be used for secondary prevention of cryptogenic stroke or TIA, but data are lacking regarding long-term outcomes. METHODS: We reviewed the Mayo Clinic Rochester PFO database for patients who underwent device closure of PFO for secondary prevention of stroke/TIA from December 2001 to June 2012. Demographic, clinical, procedural, and follow-up data were reviewed. Recurrence rate of stroke/TIA were calculated. Data were analyzed to identify risk factors of recurrent neurologic events. RESULTS: Seven hundred and thirty patients (mean age 53 years; 40% female) were included in our study. Most patients (72%) had cryptogenic stroke as their qualifying event for PFO closure. There were no procedure-related deaths or strokes. The most commonly used device was the Amplatzer Septal Occluder (82%). Median follow-up was 6 years. A 3.9% of patients had documented residual right-to-left shunting at last echocardiogram. Recurrent stroke and/or TIA were reported in 45 patients, (6.3% of patients with follow-up data). Patients who experienced recurrent stroke/TIA were older and had a higher rate of diabetes and hypertension than those who did not. The presence of residual shunt did not correlate with risk of recurrent events. CONCLUSIONS: Device closure of PFO can be performed safely with very good long-term resolution of atrial shunting. Recurrent neurologic events after PFO closure may reflect additional comorbid risk factors unrelated to the potential for paradoxical embolism. © 2016 Wiley Periodicals, Inc.

Assisted care as a baseline patient risk characteristic affecting the outcome of transcatheter aortic valve insertion.

BACKGROUND: Objective measures of frailty have not been well defined as risk factors for a poor outcome after transcatheter aortic valve insertion. We hypothesized that assisted care as a baseline patient characteristic was a simple objective measure of frailty. We reviewed our experience to assess for an association between assisted care and outcome of operation. METHODS: We retrospectively reviewed the records of 597 patients operated with transcatheter aortic valve insertion from November 2008 through July 2015. The study cohort included patients with a dichotomous baseline characteristic of receiving assisted care (AC group, n = 60, 10.1%) or not receiving assisted care (NC group, n = 537, 89.9%). The endpoints of the study were operative stroke/death and 1-year survival. RESULTS: The age of the patients was 80.6 ± 9.0 years, male sex was present in 349 (58.5%), and STS predicted risk of mortality was 9.2 ± 6.2%. Alternate access was used in 26 (43.3%) patients in the AC care group and in 220 (41.0%) in the NC group (P = 0.724). Operative stroke/death occurred in 4 (6.7%) patients in the AC group and in 25 (4.7%) in the NC group (P = 0.492). Mortality at 1 year in the AC group was 14.8 ± 5.2% and in the NC group was 12.9 ± 1.7%; (P = 0. 250). CONCLUSIONS: Assisted care as a baseline patient characteristic does not result in increased operative stroke/death or 1-year mortality in patients following transcatheter aortic valve insertion. Assisted care should not by itself preclude operation. © 2016 Wiley Periodicals, Inc.

Characteristics and outcomes of re-do percutaneous paravalvular leak closure.

BACKGROUND: Percutaneous paravalvular leak (PVL) closure is an alternative treatment option for severely symptomatic, high-surgical risk patients with PVL. Some patients require multiple percutaneous PVL closure procedures. However, the procedural characteristics and success rate of re-do PVL closure have not been well studied. AIMS: The aim of this study is to investigate the indications, procedural characteristics, technical success rate, and 30-day major adverse cardiovascular events (MACE) in patients who underwent re-do PVL closure. METHODS: Consecutive patients who underwent percutaneous paramitral or paraaortic leak closure at Mayo Clinic, Rochester, Minnesota from 2004 through 2015 were studied. Clinical and procedural characteristics of patients who underwent re-do PVL closure were compared to age- and sex-matched patients who underwent their first percutaneous PVL closure. Procedure success and 30-day MACE were compared in both the groups. RESULTS: Among 223 identified percutaneous PVL closures, 16 (7%) were re-do procedures. Patients who underwent re-do PVL closure were predominantly men (87.5%) with a mean age of 68 ± 15 years and an estimated mean Society of Thoracic Surgery (STS) 30-day mortality of 4.6 ± 2.8. Half of the re-do PVL closures were performed on mechanical valves and 62.5% were performed on paramitral defects. Indications for re-do PVL closure were: (1) emergence of new significant paravalvular defects in 50%, (2) incomplete index defect closure in 43.75%, and (3) index procedural complication in 6.25% of the cases. Procedural success was 75% in re-do procedures vs. 85.4% in age- and sex-matched control group (P = 0.45). Thirty-day MACE was 12.5% in the re-do group compared to 4.2% in the age- and-sex matched patients who underwent PVL closure for the first time (P = 0.35). CONCLUSION: Re-do percutaneous PVL closure is feasible with favorable procedural success rate and low 30-day MACE. Development of new paravalvular defects is the most common indication for re-do PVL closure, highlighting the importance of careful longitudinal monitoring and follow-up. © 2017 Wiley Periodicals, Inc.

The Learning Curve for Transcatheter Mitral Valve Repair With MitraClip.

OBJECTIVES: This study sought to assess the learning curve for TMVR for treatment of primary mitral regurgitation (MR). BACKGROUND: Data are lacking regarding the technical experience required to achieve optimal clinical outcomes with transcatheter mitral valve repair (TMVR) using the edge-to-edge MitraClip technique. METHODS: We examined the sequential experience of the first 75 patients (age 80 ± 9 years; 77% male) who underwent TMVR at our institution. A sequence number of each patient was assigned as a continuous variable and in tertiles for analysis. RESULTS: TMVR with MitraClip was successful in 97% with an average procedural time of 106 ± 39 minutes. The 30-day rate of major adverse cardiovascular events was 7%. With increased case experience, there were decreases in procedural time, fluoroscopy time, length of hospital stay, and major adverse cardiovascular events. Procedural success, residual mitral regurgitation and NYHA functional classification at 30-day follow-up remained unchanged throughout the experience. CONCLUSIONS: The learning curve for TMVR with MitraClip for treatment of primary MR is characterized by a sequential reduction in procedure time, fluoroscopy time, procedural complications, and hospital length of stay at a tertiary academic medical center. Thirty-day procedural results are favorable and similar during the initial learning period.

Transcatheter closure of postmyocardial infarction, iatrogenic, and postoperative ventricular septal defects: The Mayo Clinic experience.

OBJECTIVES: To determine event-free survival after transcatheter closure of ventricular septal defect (VSD), and to identify predictors of adverse events (AE) in post myocardial infarction VSD (post-MI VSD) subgroup. BACKGROUND: There are limited data on mid-term follow-up after transcatheter VSD closure. METHODS: Retrospective review of 27 cases of transcatheter VSD closure (post-MI = 18 and non-ischemic = 9) performed from 1999 to 2013. We defined AE as death, device embolization, hemolysis requiring blood transfusion, heart block and reintervention. RESULTS: In the post-MI VSD subgroup, mean age and follow-up was 69 ± 11 and 7.3 ± 7 years, respectively. AE occurred in 8 (44%) patients (death-3, device embolization-1, hemolysis-1, surgical VSD closure-2, reintervention-1). Event-free survival was 56% at 1 month and 5 years, and all AE occurred in the periprocedural period. Cardiogenic shock (HR: 3.21, CI: 1.82-5.41, P = 0.002), and VSD closure in acute phase (HR: 2.14, CI: 1.12-4.31, P = 0.004) were independent predictors of AE. In the non-ischemic VSD subgroup, mean age and follow-up was 49 ± 15 and 8.7 ± 8 years, respectively. AE occurred in 3 (33%) patients (late death-1, surgical VSD closure-2). For the entire cohort, freedom from death was 89% and 85% at 1 month and 5 years, and event-free survival was 70% and 61% at 1 month and 5 years. CONCLUSIONS: Transcatheter closure of post-MI VSD carries a moderate risk of periprocedural complications but low event rates afterwards. By comparison, device closure of non-ischemic VSD has lower periprocedural morbidity but some patients continued to experience AE during follow-up.