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2.
Am J Cardiol ; 2020 Apr 24.
Artigo em Inglês | MEDLINE | ID: mdl-32402487

RESUMO

With aging population and preponderance of severe aortic stenosis occurring in elderly patients, the number of transcatheter aortic valve implantations (TAVI) performed in the elderly are growing. Frailty is common in the elderly and is known to be associated with worse outcomes. We aimed to evaluate the impact of frailty on hospital readmissions rates after TAVI. We used the 2016 Nationwide Readmission Database and categorized patients who underwent TAVI low, intermediate, and high frailty status. The primary outcome was 6-months readmission rates across the 3 frailty categories. Secondary outcomes included causes of readmissions, in-hospital mortality and cost of care. STATA 16.0 was used for survey-specific statistical tests. Of 20,504 patients who underwent TAVI, 58.9% were low-, 39.6% were intermediate-, and 1.5% were in the high-frailty group. Overall in-hospital mortality was 1.9% (n = 396), and was 0.6%, 3.3%, and 16.8% (p <0.01) with increasing frailty. Of the 20,108 patients who survived to discharge, 6,427 (32%) patients were readmitted within 6-months after TAVI. Readmission rates increased across the categories from 27.9% in low, 37.6% in intermediate and 51.1% in high frailty group (p <0.01). While cardiac causes (mostly heart failure) were the predominant readmission etiologies across frailty categories (low: 51.2%, intermediate: 34.1%, high: 27.2%), rates of infectious and injury-related readmissions increased (low: 11%, intermediate: 30%, high: 45%). Mortality during readmissions also worsened from 0.8%, 5.3%, and 8.5% (p <0.01). Over 40% of patients undergoing TAVI were of intermediate-high frailty. In conclusion, an increasing frailty was associated with significantly worse postprocedure mortality, readmissions, and related mortality.

3.
JACC Cardiovasc Interv ; 13(10): 1251-1261, 2020 May 25.
Artigo em Inglês | MEDLINE | ID: mdl-32360260

RESUMO

OBJECTIVES: The aim of this study was to assess the value of echocardiographic right ventricular (RV) and systolic pulmonary artery pressure (sPAP) assessment in predicting transcatheter tricuspid edge-to-edge valve repair (TTVR) outcome. BACKGROUND: RV dysfunction and pulmonary hypertension are associated with poor prognosis and are systematically sought during tricuspid regurgitation evaluation. The value of echocardiographic assessment in predicting TTVR outcome is unknown. METHODS: Data were taken from the TriValve (Transcatheter Tricuspid Valve Therapies) registry, which includes patients undergoing TTVR at 14 European and North American centers. The primary outcome was 1-year survival free from hospitalization for heart failure, and secondary outcomes were 1-year survival and absence of hospital admission for heart failure at 1 year. RESULTS: Overall, 249 patients underwent TTVR between June 2015 and 2018 (mean tricuspid annular plane systolic excursion [TAPSE] 15.8 ± 15.3 mm, mean sPAP 43.6 ± 16.0 mm Hg). Tricuspid regurgitation grade ≥3+ was found in 96.8% of patients at baseline and 29.4% at final follow-up; 95.6% were in New York Heart Association functional class III or IV initially, compared with 34.3% at follow-up (p < 0.05). Final New York Heart Association functional class did not differ among TAPSE and sPAP quartiles, even when both low TAPSE and high sPAP were present. Rates of 1-year survival and survival free from hospitalization for heart failure were 83.9% and 78.7%, respectively, without significant differences according to baseline echocardiographic RV characteristics (TAPSE, fractional area change, and end-diastolic area) and sPAP (p > 0.05 for all). CONCLUSIONS: TTVR provides clinical improvement, with 1-year survival free from hospital readmission >75% in patients with severe tricuspid regurgitation. Conventional echocardiographic parameters used to assess RV function and sPAP did not predict clinical outcome after TTVR.

4.
Surg Technol Int ; 36: 217-223, 2020 May 28.
Artigo em Inglês | MEDLINE | ID: mdl-32379893

RESUMO

Severe tricuspid regurgitation (TR) is associated with significant mortality and morbidities. Currently, surgical tricuspid repair with annuloplasty is the gold standard treatment. However, the prohibitive risks of open surgery and increasing evidence that severe TR should be intervened on early has led to an outburst in the development and evolution of transcatheter tricuspid valve interventions (TTVI). These technologies are broadly categorized into direct suture annuloplasty devices, minimally invasive annuloplasty, direct ring annuloplasty devices, coaptation-based strategies, edge-to-edge repair devices, and transcatheter valve replacement. Each has its own set of advantages and limitations and have been tried, to varying degrees of success, in a myriad of pathoanatomic scenarios. Challenges faced in TTVI device and trial designs include heterogeneous patient populations, the need for quality imaging, variations of imaging requirements and anatomic criteria by device, hard-to-define clinical endpoints, and the poor prognosis carried by significant residual TR. Similar to tricuspid valve disease, pulmonic valve (PV) disease can occur on its own or secondary to a congenital heart defect, most commonly tetralogy of Fallot. Many patients with pulmonic stenosis or insufficiency often require repeat surgical interventions for other cardiac problems, highlighting the importance of developing transcatheter approaches to reduce the number of repeat open-heart surgeries required. Transcatheter PV replacement (TPVR) is growing in use and is the procedure of choice in patients with failed bioprostheses via valve-in-valve implantation. The Melody (Medtronic Inc., Minneapolis, Minnesota) and SAPIEN XT (Edwards Lifesciences Inc., Irvine, California) devices are the currently available TPVR technologies. Current limitations here include device kinking, the risk of stent fracture, anatomic difficulties, such as asymmetric right ventricular outflow tracts leading to poor landing zones and procedural risks of coronary artery and aortic root compression.

5.
Artigo em Inglês | MEDLINE | ID: mdl-32417332

RESUMO

OBJECTIVES: This study aims to establish a computed tomography (CT)-based scoring system for grading mitral annular calcification (MAC) severity and potentially aid in predicting valve embolization during transcatheter mitral valve (MV) replacement using balloon-expandable aortic transcatheter heart valves. BACKGROUND: Transcatheter MV replacement is emerging as an alternative treatment for patients with severe MAC who are not surgical candidates. Although cardiac CT is the imaging modality of choice in the evaluation of candidates for valve-in-MAC (ViMAC), a standardized grading system to quantify MAC severity has not been established. METHODS: We performed a multicenter retrospective review of cardiac CT and clinical outcomes of patients undergoing ViMAC. A CT-based MAC score was created using the following features: average calcium thickness (mm), degrees of annulus circumference involved, calcification at one or both fibrous trigones, and calcification of one or both leaflets. Features were assigned points according to severity (total maximum score = 10) and severity grade was assigned based on total points (mild ≤3, moderate 4 to 6, and severe ≥7 points). The association between MAC score and device migration/embolization was evaluated. RESULTS: Of 117 patients in the TMVR in MAC registry, 87 had baseline cardiac CT of adequate quality. Of these, 15 were treated with transatrial access and were not included. The total cohort included 72 (trans-septal = 37, transapical = 35). Mean patient age was 74 ± 12 years, 66.7% were female, and the mean Society of Thoracic Surgery risk score was 15.4% ± 10.5. The mean MAC score was 7.7 ± 1.4. Embolization/migration rates were lower in higher scores: Patients with a MAC score of 7 had valve embolization/migration rate of 12.5%, MAC score ≥8 had a rate of 8.7%, and a MAC score of ≥9 had zero (p = 0.023). Patients with a MAC score of ≤6 had 60% embolization/migration rate versus 9.7% in patients with a MAC score ≥7 (p < 0.001). In multivariable analysis, a MAC score ≤6 was in independent predictor of valve embolization/migration (odds ratio [OR]: 5.86 [95% CI: 1.00 to 34.26]; p = 0.049). CONCLUSIONS: This cardiac CT-based score provides a systematic method to grade MAC severity which may assist in predicting valve embolization/migration during trans-septal or transapical ViMAC procedures.

6.
Am J Cardiol ; 125(10): 1558-1565, 2020 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-32247652

RESUMO

Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is an alternative to redo-surgery in patients with failed surgical bioprostheses. It remains unclear whether outcomes vary when using either self-expanding (SE) or balloon-expandable (BE) valves. The aim of this study was to compare outcomes between SE and BE transcatheter heart valves when used for ViV TAVI. A systematic review of PubMed, MEDLINE, and EMBASE was performed identifying studies reporting outcomes following ViV TAVI. Event rates were pooled for meta-analysis using a random-effects model. The primary outcome was all-cause mortality at 12 months. Secondary outcomes included 30-day and 3-year mortality in addition to standard safety outcomes after the procedure as per the Valve Academic Research Consortium criteria. Nineteen studies reporting outcomes for 1,772 patients were included: 924 in the SE group and 848 patients in the BE group. There was no significant difference in all-cause mortality at 12 months (SE 10.3% vs BE 12.6%, p = 0.165, I2 = 0%), or 3 years (SE 21.2% vs BE 31.2%, p = 0.407, I2 = 63.79). SE valves had lower transvalvular gradients after procedure and acute kidney injury, but higher rates of pacemaker insertion, moderate or severe paravalvular regurgitation and need for ≥2 valves (all p < 0.05). There were no differences in stroke, coronary obstruction, bleeding, or vascular complications. Despite significant differences in key procedural outcomes between SE and BE valves when used for ViV TAVI, we found no difference in 12-month mortality. Tailored device selection may further reduce the risk of adverse procedural outcomes, particularly over the longer term.

8.
JACC Cardiovasc Interv ; 13(9): 1030-1042, 2020 May 11.
Artigo em Inglês | MEDLINE | ID: mdl-32192985

RESUMO

OBJECTIVES: The aim of this study was to evaluate the impact of initial deployment orientation of SAPIEN 3, Evolut, and ACURATE-neo transcatheter heart valves on their final orientation and neocommissural overlap with coronary arteries. BACKGROUND: Coronary artery access and redo transcatheter aortic valve replacement (TAVR) following initial TAVR may be influenced by transcatheter heart valve orientation. In this study the impact of transcatheter heart valve deployment orientation on commissural alignment was evaluated. METHODS: Pre-TAVR computed tomography and procedural fluoroscopy were analyzed in 828 patients who underwent TAVR (483 SAPIEN 3, 245 Evolut, and 100 ACURATE-neo valves) from March 2016 to September 2019 at 5 centers. Coplanar fluoroscopic views were coregistered to pre-TAVR computed tomography to determine commissural alignment. Severe overlap between neocommissural posts and coronary arteries was defined as 0° to 20° apart. The SAPIEN 3 had 1 commissural post crimped at 3, 6, 9, and 12 o'clock. The Evolut "Hat" marker and ACURATE-neo commissural post at deployment were classified as center back (CB), inner curve (IC), outer curve (OC), or center front (CF) and matched with final orientation. RESULTS: Initial SAPIEN 3 crimped orientation had no impact on commissural alignment. Evolut "Hat" at OC or CF at initial deployment had less severe overlap than IC or CB (p < 0.001) against the left main (15.7% vs. 66.0%) and right coronary (7.1% vs. 51.1%) arteries. Tracking Evolut "Hat" at OC of the descending aorta (n = 107) improved OC at deployment from 70.2% to 91.6% (p = 0.002) and reduced coronary artery overlap by 36% to 60% (p < 0.05). ACURATE-neo commissural post at CB or IC during deployment had less coronary artery overlap compared to CF or OC (p < 0.001), with intentional alignment successful in 5 of 7 cases. CONCLUSIONS: This is the first systematic evaluation of commissural alignment in TAVR. More than 30% to 50% of cases had overlap with 1 or both coronary arteries. Initial SAPIEN 3 orientation had no impact on alignment, but specific initial orientations of Evolut and ACURATE improved alignment. Optimizing valve alignment to avoid coronary artery overlap will be important in coronary artery access and redo TAVR.

12.
Am J Cardiol ; 125(9): 1378-1384, 2020 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-32139158

RESUMO

Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) for a failing prosthesis is an appealing alternative to redo surgical AVR. We utilized data from the US National Inpatient Sample for the period 2012 to 2016 to identify hospitalizations for either ViV-TAVI or redo-SAVR. The primary outcomes of interest were in-hospital adverse events composite outcome (comprising of mortality, myocardial infarction, stroke, or acute kidney injury) and all-cause mortality. We used propensity score matching to adjust for the baseline differences between ViV-TAVI and redo-SAVR cohorts. Survey techniques were employed to compare the 2 groups. Over 5 years, there has been a considerable increase in both interventions for prosthetic aortic valve failure, with significantly higher utilization of ViV-TAVI compared to redo-SAVR (p <0.01). Out of the 3,305 hospitalizations for prosthetic aortic valve failure, 1,420 in matched pairs underwent either ViV-TAVI (n = 710) or redo-SAVR (n = 710). ViV-TAVI was associated with lower in-hospital composite adverse outcomes (14.1% vs 25.4%, p = 0.018), and numerically lower but statistically insignificant mortality (<1.0% vs 5.2%; p = 0.06). ViV-TAVI was associated with a decreased length of hospitalization (mean 6.6 vs 9.7 days; p <0.01). In the matched cohort, postoperative bleeding and transfusions were significantly lower for ViV-TAVI compared with redo-SAVR (17.6% vs 31.0% and 12% vs 31% respectively, p <0.01 for both). Acute kidney injury, sepsis, permanent pacemaker implantation, and vascular complications, although numerically better, did not differ between 2 strategies. In conclusion, ViV-TAVI is associated with lower in-hospital MACE rates and reduced length of hospitalization compared with redo-SAVR.

16.
Am J Cardiol ; 125(8): 1222-1229, 2020 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-32093955

RESUMO

New persistent left bundle branch block (NP-LBBB) has been associated with adverse outcomes after TAVI but few predictors thus far reported. We sought to identify predictors of NP-LBBB after TAVI with EvolutR/PRO (ER/EP). From 1/2016 to 4/2019, 544 patients from 2 centers underwent TAVI with Evolut (54% ER, 46% EP) for severe native aortic stenosis. Patients with previous LBBB and pacemaker were excluded. Aortic root analysis was performed using 3Mensio Valves Software and membranous septal length (MSL) was determined using the standard coronal view. Clinical, anatomic and procedural characteristics of 396 Evolut were analyzed and predictors of NP-LBBB were identified. Valve Academic Research Consortium-2 outcomes were reported. At discharge, NP-LBBB was seen in 76(19.2%) patients. NP-LBBB in Evolut was associated with implant depth at left coronary cusp (p = 0.004) and 34 mm ER (p = 0.026). Independent predictors of NP-LBBB in Evolut were shorter MSL (odds ratio [OR] = 0.82 per mm septum, 95% confidence interval [CI] = 0.68 to 0.98,p = 0.030), left ventricular outflow tract (LVOT) eccentricity (OR = 1.04 per %, 95% CI = 1.01 to 1.06,p = 0.002), implant depth at noncoronary cusp (NCC) (OR = 1.28 per mm ventricular, 95% CI = 1.11 to 1.48,p = 0.001) and annular perimeter oversizing ≥20% (OR = 2.38, 95% CI = 1.20 to 4.72, p = 0.013). On ROC curve analysis, MSL ≤6.5 mm, NCC depth ≥3 mm and LVOT eccentricity ≥35% were optimal threshold values to predict NP-LBBB. In Conclusion, shorter MSL, LVOT eccentricity, annular oversizing and deeper implant depth are novel predictors of NP-LBBB in Evolut TAVI. Preprocedural CT assessment of aortic root anatomy may help identify patients at risk for NP-LBBB. In such patients, modifying procedural factors such as higher implant and less annular oversizing may reduce the risk of NP-LBBB. Further evaluation of our hypothesis is warranted.

18.
JACC Cardiovasc Interv ; 13(5): 554-564, 2020 Mar 09.
Artigo em Inglês | MEDLINE | ID: mdl-31954676

RESUMO

OBJECTIVES: The interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific therapeutic challenges during transcatheter tricuspid valve intervention (TTVI). Feasibility and efficacy of TTVI in presence of a CIED is unclear. BACKGROUND: Feasibility of TTVI in presence of a CIED lead has never been proven on a large basis. METHODS: The study population consisted of 470 patients with severe symptomatic TR from the TriValve (Transcatheter Tricuspid Valve Therapies) registry who underwent TTVI at 21 centers between 2015 and 2018. The association of CIED and outcomes were assessed. RESULTS: Pre-procedural CIED was present in 121 of 470 (25.7%) patients. The most frequent location of the CIED lead was the posteroseptal commissure (44.0%). As compared with patients without a transvalvular lead (no-CIED group), patients having a tricuspid lead (CIED group) were more symptomatic (New York Heart Association functional class III to IV in 95.9% vs. 92.3%; p = 0.02) and more frequently had previous episodes of right heart failure (87.8% vs. 69.0%; p = 0.002). No-CIED patients had more severe TR (effective regurgitant orifice area 0.7 ± 0.6 cm2 vs. 0.6 ± 0.3 cm2; p = 0.02), but significantly better right ventricular function (tricuspid annular plane systolic excursion = 16.7 ± 5.0 mm vs. 15.9 ± 4.0 mm; p = 0.04). Overall, 373 patients (79%) were treated with the MitraClip (Abbott Vascular, Santa Clara, California) (106 [87.0%] in the CIED group). Among them, 154 (33%) patients had concomitant transcatheter mitral repair (55 [46.0%] in the CIED group, all MitraClip). Procedural success was achieved in 80.0% of no-CIED patients and in 78.6% of CIED patients (p = 0.74), with an in-hospital mortality of 2.9% and 3.7%, respectively (p = 0.70). At 30 days, residual TR ≤2+ was observed in 70.8% of no-CIED and in 73.7% of CIED patients (p = 0.6). Symptomatic improvement was observed in both groups (NYHA functional class I to II at 30 days: 66.0% vs. 65.0%; p = 0.30). Survival at 12 months was 80.7 ± 3.0% in the no-CIED patients and 73.6 ± 5.0% in the CIED patients (p = 0.30). CONCLUSIONS: TTVI is feasible in selected patients with CIED leads and acute procedural success and short-term clinical outcomes are comparable to those observed in patients without a transtricuspid lead.

19.
Curr Opin Cardiol ; 35(2): 107-115, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31895243

RESUMO

PURPOSE OF REVIEW: The aim of the article is to discuss different therapeutic options for patients with severe mitral valve dysfunction because of mitral annular calcification (MAC), including mitral valve repair, conventional mitral valve replacement, percutaneous transcatheter mitral valve replacement (TMVR), and hybrid procedures. RECENT FINDINGS: Optimal management of severe mitral valve disease because of MAC remains challenging. Various 'resect' or 'respect' repair strategies have been standardized and are applicable in eligible patients. Mitral valve replacement with a standard surgical bioprosthesis is often possible in nonrepair candidates, especially with noncircumferential MAC. TMVR has evolved as a feasible option for anatomically and/or clinically prohibitive open-surgery cases, with the caveat of strict anatomic eligibility criteria. Hybrid TMVR provides the advantages of both open-surgery and TMVR and has emerged as a promising alternative in select patients. SUMMARY: Surgical management of MAC and severe mitral valve disease continues to evolve. The addition of transcatheter valve options may benefit many patients previously considered inoperable and are now candidates for intervention. This review will summarize state-of-the-art management options for patients with MAC.

20.
Am J Cardiol ; 125(7): 1083-1087, 2020 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-31982103

RESUMO

Transcatheter mitral valve repair (TMVR) has shown comparable outcomes to surgical mitral valve replacement or repair (SMVR) in patients who are at a higher risk of surgical complications and therefore are not amenable to surgery. Elderly patients are considered poor surgical candidates due to their advanced age, and presence of comorbidities. A sub-analysis of EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) trial identified patients of >70 years of age appear to have a similar risk-benefit profile for either approach of surgery or transcatheter. This finding does have some caveats considering the trial included surgical cohort with both repair and replacement. Utilizing the National Inpatient Sample, we identified a surgical cohort of ≥80 years of age that underwent mitral valve repair and used propensity matching to compare it with a similar cohort that underwent TMVR. In a well-balanced cohort, TMVR was associated with significantly lower in-patient mortality (0.7% vs 3.1%). TMVR was also associated with significantly decreased in-hospital complications such as acute kidney injury, cardiogenic shock, postoperative hemorrhage, transfusion, permanent pacemaker, and respiratory and vascular complications. Owing to this, the duration of hospital stay is approximately 6 days less with TMVR. Trend analysis has shown a paradigm shift in these elderly patients with 85% of all repairs in 2012 were performed surgically, whereas in 2016 almost 94% of all the repairs being performed via a transcatheter approach. In conclusion, in patients ≥80 years of age, the surgical MVR had 4-fold higher mortality compared to TMVR with higher cardiac, vascular, hemorrhagic and respiratory complications. Despite the limitations of being observational in nature, this data strongly supports the preferential use of the transcatheter approach for mitral valve repair in patients ≥80 years of age.

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