Publications by authors named "Ignacio Inglessis"

64 Publications

Managing Severe Aortic Stenosis in the COVID-19 Era.

JACC Cardiovasc Interv 2020 08 1;13(16):1937-1944. Epub 2020 Jun 1.

Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address:

The novel coronavirus disease-2019 (COVID-19) pandemic has created uncertainty in the management of patients with severe aortic stenosis. This population experiences high mortality from delays in treatment of valve disease but is largely overlapping with the population of highest mortality from COVID-19. The authors present strategies for managing patients with severe aortic stenosis in the COVID-19 era. The authors suggest transitions to virtual assessments and consultation, careful pruning and planning of necessary testing, and fewer and shorter hospital admissions. These strategies center on minimizing patient exposure to COVID-19 and expenditure of human and health care resources without significant sacrifice to patient outcomes during this public health emergency. Areas of innovation to improve care during this time include increased use of wearable and remote devices to assess patient performance and vital signs, devices for facile cardiac assessment, and widespread use of clinical protocols for expedient discharge with virtual physical therapy and cardiac rehabilitation options.
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http://dx.doi.org/10.1016/j.jcin.2020.05.045DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7263810PMC
August 2020

Impact of bleeding after transcatheter aortic valve replacement in patients with chronic kidney disease.

Catheter Cardiovasc Interv 2021 Jan 22;97(1):E172-E178. Epub 2020 May 22.

Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.

Objective: In patients with chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR), this study aims to elucidate (a) the bleeding risks associated with CKD, (b) the association between bleeding and subsequent mortality, and (c) the pattern of antithrombotic therapy prescribed.

Background: Patients with CKD have a higher risk of bleeding following TAVR. It is unclear whether this risk persists beyond the periprocedural period and whether it negatively impacts mortality.

Methods: A retrospective review was performed on patients who underwent TAVR at Massachusetts General Hospital from 2008 to 2017. CKD was defined as estimated glomerular filtration rate less than 60 ml/min/1.73 m . Primary endpoints up to 1-year following TAVR included bleeding, all-cause mortality, and ischemic stroke. Outcomes for patients with and without CKD were compared using log-rank test, and Cox regression with age, sex, and diabetes as covariates. Bleeding was treated as a time-varying covariate, and Cox proportional hazard regression was utilized to model mortality.

Results: Of the 773 patients analyzed, 466 (60.3%) had CKD. At 1 year, CKD patients had higher rates of bleeding (9.2 vs. 4.9%, adjusted hazard ratios [aHR] = 1.91, p = .032) and all-cause mortality (13.7 vs. 9.1%, aHR = 1.57, p = .049), but not stroke (3.9 vs. 1.6% aHR = 0.073, p = .094). Bleeding was associated with an increased risk of subsequent mortality (aHR = 2.65, 95% CI: 1.25-5.63, p = .01). There were no differences in the antithrombotic strategy following TAVR between CKD and non-CKD patients.

Conclusion: CKD is associated with a higher risk of bleeding up to 1 year following TAVR. Long-term bleeding after TAVR is associated with increased subsequent mortality.
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http://dx.doi.org/10.1002/ccd.28989DOI Listing
January 2021

Temporal Trends in Prevalence of Tricuspid Valve Disease in Hospitalized Patients in the United States.

Am J Cardiol 2020 06 2;125(12):1879-1883. Epub 2020 Apr 2.

Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts. Electronic address:

Tricuspid valve disease (TVD), particularly tricuspid regurgitation, is a common valvular pathology that is associated with increased morbidity and mortality. The prevalence of TVD in hospitalized patients has not been well characterized. We used the National Inpatient Sample to determine the overall and age- and sex-specific prevalence and temporal trends in prevalence of TVD in hospitalized patients in the US. All-cause and heart failure (HF) hospitalizations in patients ≥50 years of age from January 2006 to September 2015 in the US were identified. Temporal trends in the prevalence of TVD were studied using Poisson regression. Of 194,184,433 all-cause and 38,083,773 HF hospitalizations in patients ≥50 years of age, 3,235,292 (1.7%) and 1,787,548 (4.7%) had a diagnosis of TVD, respectively. From 2006 to 2015, the prevalence of TVD in all hospitalizations and in HF hospitalizations increased from 1.7% to 2.0% and from 3.9% to 5.7%, respectively (p <0.001 for both), particularly in those ≥85 years of age and in women. In patients with TVD, primary reasons for hospitalizations were HF (20.8%), infections (10.1%), arrhythmias (9.8%), respiratory conditions (8.4%), and coronary artery disease/acute myocardial infarction (8.2%). In-hospital mortality and length of stay in patients with TVD remained unchanged, whereas costs of hospitalization increased during the study period. In conclusion, the prevalence of TVD in all hospitalized patients and in those hospitalized with HF has increased over the past several years, particularly in those ≥85 years of age and in women. Approximately 1 in 5 hospitalizations with a diagnosis of TVD is due to HF.
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http://dx.doi.org/10.1016/j.amjcard.2020.03.033DOI Listing
June 2020

SCAI position statement on adult congenital cardiac interventional training, competencies and organizational recommendations.

Catheter Cardiovasc Interv 2020 09 9;96(3):643-650. Epub 2020 Apr 9.

Mattel Children's Hospital at UCLA, Los Angeles, California, USA.

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http://dx.doi.org/10.1002/ccd.28885DOI Listing
September 2020

Perforating the GORE® CARDIOFORM septal occluder and atrial septal defect occluder to gain access to the left atrium.

Catheter Cardiovasc Interv 2020 Nov 2;96(6):E660-E665. Epub 2020 Apr 2.

Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts, USA.

Objective: Perforate the expanded polytetrafluoroethylene membrane of the GORE® CARDIOFORM Septal Occluder (GSO) and GORE® CARDIOFORM ASD Occluder (GCA) after implantation.

Background: Percutaneous transseptal access to the left atrium is necessary for many structural and electrophysiological procedures. The potential need to access the left atrium may influence decision-making for patent foramen ovale or atrial septal defect closure.

Methods: Sixteen canines underwent implantation of equal number GSO or GCA devices. A transseptal crossing procedure was performed through the device 85 (±1) days postoccluder implantation. The crossing procedure was performed utilizing commercially available equipment: radiofrequency/SureFlex sheath and standard needle/Mullin's sheath. Progressive dilation of the perforation was performed to allow passage of a 12 French Mullin's sheath into the left atrium.

Results: Left atrial access was achieved in all cases. Postmortem analysis demonstrated passage through both occluder discs in all radiofrequency/SureFlex sheath cases (4 GSO, 4 GCA) and half of the standard needle/Mullin's sheath cases (3 GSO, 1 GCA). The remaining standard needle/Mullin's sheath cases demonstrated perforation through the right atrial disc but passage around the septal aspect of the left atrial disc, thus not perforating the left atrial disc. No acute embolic complications from the procedure were observed.

Conclusions: Left atrial access may be achieved through the GSO or GCA devices after implantation and endothelialization. The combination of a radiofrequency needle and steerable sheath provides benefit over a standard needle and Mullin's sheath in accomplishing passage through both occluder discs.
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http://dx.doi.org/10.1002/ccd.28884DOI Listing
November 2020

Bioprosthetic Aortic Valve Leaflet Thickening in the Evolut Low Risk Sub-Study.

J Am Coll Cardiol 2020 05 28;75(19):2430-2442. Epub 2020 Mar 28.

Department of Cardiothoracic Surgery, Methodist DeBakey Heart and Vascular Center, Houston, Texas.

Background: Subclinical leaflet thrombosis has been reported after bioprosthetic aortic valve replacement, characterized using 4-dimensional computed tomographic imaging by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM). The incidence and clinical implications of these findings remain unclear.

Objectives: The aim of this study was to determine the frequency, predictors, and hemodynamic and clinical correlates of HALT and RLM after aortic bioprosthetic replacement.

Methods: A prospective subset of patients not on oral anticoagulation enrolled in the Evolut Low Risk randomized trial underwent computed tomographic imaging 30 days and 1 year after transcatheter aortic valve replacement (TAVR) or surgery. The primary endpoint was the frequency of HALT at 30 days and 1 year, analyzed by an independent core laboratory using standardized definitions. Secondary endpoints included RLM, mean aortic gradient, and clinical events at 30 days and 1 year.

Results: At 30 days, the frequency of HALT was 31 of 179 (17.3%) for TAVR and 23 of 139 (16.5%) for surgery; the frequency of RLM was 23 of 157 (14.6%) for TAVR and 19 of 133 (14.3%) for surgery. At 1 year, the frequency of HALT was 47 of 152 (30.9%) for TAVR and 33 of 116 (28.4%) for surgery; the frequency of RLM was 45 of 145 (31.0%) for TAVR and 30 of 111 (27.0%) for surgery. Aortic valve hemodynamic status was not influenced by the presence or severity of HALT or RLM at either time point. The rates of HALT and RLM were similar after the implantation of supra-annular, self-expanding transcatheter, or surgical bioprostheses.

Conclusions: The presence of computed tomographic imaging abnormalities of aortic bioprostheses were frequent but dynamic in the first year after self-expanding transcatheter and surgical aortic valve replacement, but these findings did not correlate with aortic valve hemodynamic status after aortic valve replacement in patients at low risk for surgery. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).
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http://dx.doi.org/10.1016/j.jacc.2020.03.022DOI Listing
May 2020

Effect of Residual Interatrial Shunt on Migraine Burden After Transcatheter Closure of Patent Foramen Ovale.

JACC Cardiovasc Interv 2020 02;13(3):293-302

Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.

Objectives: This study sought to evaluate the long-term effect of transcatheter patent foramen ovale (PFO) closure on migraineurs with and without aura and examine the effect of residual right-to-left shunt.

Background: Many studies reported improvement in migraine symptoms after PFO closure, yet randomized trials failed to reach its clinical endpoints.

Methods: The study retrospectively analyzed data from 474 patients who underwent transcatheter PFO closure at Massachusetts General Hospital. Patients completed a migraine burden questionnaire at baseline and at follow-up. Migraine severity is reported as migraine frequency (days/month), average duration (min), and migraine burden (days × min/month). Improvement following closure was defined as complete abolishment of symptoms or >50% reduction in migraine burden.

Results: A total of 110 migraineurs who underwent PFO closure were included; 77.0% had aura and 23.0% were without aura, and 91.0% had a cryptogenic stroke. During long-term median follow-up of 3.2 (interquartile range: 2.1 to 4.9) years, there was a significant improvement in migraine symptoms in migraineurs with or without aura. Migraine burden was reduced by >50% in 87.0% of patients, and symptoms were completely abolished in 48%. Presence of aura was associated with abolishment of migraine (odds ratio: 4.30; 95% confidence interval: 1.50 to 12.30; p = 0.006). At 6 months after PFO closure, residual right-to-left shunt was present in 26% of patients. Absence of right-to-left shunt was associated with improvement in migraine burden by >50% (odds ratio: 4.60; 95% confidence interval: 1.30 to 16.10; p = 0.017).

Conclusions: Long-term follow-up after transcatheter PFO closure was associated with significant improvement in migraine burden. Aura was a predictor of abolishing symptoms. Absence of residual right-to-left shunt was a predictor of significant reduction in migraine burden.
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http://dx.doi.org/10.1016/j.jcin.2019.09.042DOI Listing
February 2020

Thirty-day readmissions after transcatheter versus surgical mitral valve repair in high-risk patients with mitral regurgitation: Analysis of the 2014-2015 Nationwide readmissions databases.

Catheter Cardiovasc Interv 2020 09 23;96(3):664-674. Epub 2019 Dec 23.

Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.

Objective: Determine the rates, reasons, predictors, and costs of 30-day readmissions following transcatheter mitral valve repair (TMVR) versus surgical mitral valve repair (SMVR) in the United States.

Background: Data on 30-day readmissions after TMVR are limited.

Methods: High-risk patients with mitral regurgitation (MR) undergoing TMVR or SMVR were identified from the 2014-2015 Nationwide Readmissions Databases. Multivariable stepwise regression models were used to identify independent predictors of 30-day readmission. Risk of 30-day readmission was compared between the two groups using univariate and propensity score adjusted regression models.

Results: Among 8,912 patients undergoing mitral valve repair during 2014-2015 (national estimate 17,809), we identified 7,510 (84.7%) that underwent SMVR and 1,402 (15.3%) that underwent TMVR. Thirty-day readmission rates after SMVR and TMVR were 10.7% and 11.7%, respectively (unadjusted OR 1.11, 95% CI 0.89-1.39, p = .35). After propensity score adjustment, TMVR was associated with a lower risk of 30-day readmissions compared with SMVR (adjusted OR 0.70, 95% CI 0.51-0.95, p = .02). Heart failure and arrhythmias were the leading cardiac reasons for readmission. Anemia and fluid and electrolyte disorder were independent predictors of 30-day readmission after TMVR. Demographics, comorbidities, and length of stay were independent predictors of 30-day readmission after SMVR.

Conclusions: One in 10 patients are readmitted within 30 days following TMVR or SMVR. Approximately half of the readmissions are for cardiac reasons. The predictors of 30-day readmission are different among patients undergoing TMVR and SMVR, but can be easily screened for to identify patients at highest risk for readmission.
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http://dx.doi.org/10.1002/ccd.28647DOI Listing
September 2020

Association of Pulmonary Hypertension With Clinical Outcomes of Transcatheter Mitral Valve Repair.

JAMA Cardiol 2020 01;5(1):47-56

Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston.

Importance: Pulmonary hypertension (pHTN) is associated with increased risk of mortality after mitral valve surgery for mitral regurgitation. However, its association with clinical outcomes in patients undergoing transcatheter mitral valve repair (TMVr) with a commercially available system (MitraClip) is unknown.

Objective: To assess the association of pHTN with readmissions for heart failure and 1-year all-cause mortality after TMVr.

Design, Setting, And Participants: This retrospective cohort study analyzed 4071 patients who underwent TMVr with the MitraClip system from November 4, 2013, through March 31, 2017, across 232 US sites in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry. Patients were stratified into the following 4 groups based on invasive mean pulmonary arterial pressure (mPAP): 1103 with no pHTN (mPAP, <25 mm Hg [group 1]); 1399 with mild pHTN (mPAP, 25-34 mm Hg [group 2]); 1011 with moderate pHTN (mPAP, 35-44 mm Hg [group 3]); and 558 with severe pHTN (mPAP, ≥45 mm Hg [group 4]). Data were analyzed from November 4, 2013, through March 31, 2017.

Interventions: Patients were stratified into groups before TMVr, and clinical outcomes were assessed at 1 year after intervention.

Main Outcomes And Measures: Primary end point was a composite of 1-year mortality and readmissions for heart failure. Secondary end points were 30-day and 1-year mortality and readmissions for heart failure. Linkage to Centers for Medicare & Medicaid Services administrative claims was performed to assess 1-year outcomes in 2381 patients.

Results: Among the 4071 patients included in the analysis, the median age was 81 years (interquartile range, 73-86 years); 1885 (46.3%) were women and 2186 (53.7%) were men. The composite rate of 1-year mortality and readmissions for heart failure was 33.6% (95% CI, 31.6%-35.7%), which was higher in those with pHTN (27.8% [95% CI, 24.2%-31.5%] in group 1, 32.4% [95% CI, 29.0%-35.8%] in group 2, 36.0% [95% CI, 31.8%-40.2%] in group 3, and 45.2% [95% CI, 39.1%-51.0%] in group 4; P < .001). Similarly, 1-year mortality (16.3% [95% CI, 13.4%-19.5%] in group 1, 19.8% [95% CI, 17.0%-22.8%] in group 2, 22.4% [95% CI, 18.8%-26.1%] in group 3, and 27.8% [95% CI, 22.6%-33.3%] in group 4; P < .001) increased across pHTN groups. The association of pHTN with mortality persisted despite multivariable adjustment (hazard ratio per 5-mm Hg mPAP increase, 1.05; 95% CI, 1.01-1.09; P = .02).

Conclusions And Relevance: These findings suggest that pHTN is associated with increased mortality and readmission for heart failure in patients undergoing TMVr using the MitraClip system for severe mitral regurgitation. Further efforts are needed to determine whether earlier intervention before pHTN develops will improve clinical outcomes.
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http://dx.doi.org/10.1001/jamacardio.2019.4428DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6902209PMC
January 2020

Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients.

J Am Coll Cardiol 2019 09;74(12):1532-1540

Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address:

Background: Transcatheter aortic valve replacement (TAVR) has emerged as a safe and effective therapeutic option for patients with severe aortic stenosis (AS) who are at prohibitive, high, or intermediate risk for surgical aortic valve replacement (SAVR). However, in low-risk patients, SAVR remains the standard therapy in current clinical practice.

Objectives: This study sought to perform a meta-analysis of randomized controlled trials (RCTs) comparing TAVR versus SAVR in low-risk patients.

Methods: Electronic databases were searched from inception to March 20, 2019. RCTs comparing TAVR versus SAVR in low-risk patients (Society of Thoracic Surgeons Predicted Risk of Mortality [STS-PROM] score <4%) were included. Primary outcome was all-cause death at 1 year. Random-effects models were used to calculate pooled risk ratio (RR) and corresponding 95% confidence interval (CI).

Results: The meta-analysis included 4 RCTs that randomized 2,887 patients (1,497 to TAVR and 1,390 to SAVR). The mean age of patients was 75.4 years, and the mean STS-PROM score was 2.3%. Compared with SAVR, TAVR was associated with significantly lower risk of all-cause death (2.1% vs. 3.5%; RR: 0.61; 95% CI: 0.39 to 0.96; p = 0.03; I = 0%) and cardiovascular death (1.6% vs. 2.9%; RR: 0.55; 95% CI: 0.33 to 0.90; p = 0.02; I = 0%) at 1 year. Rates of new/worsening atrial fibrillation, life-threatening/disabling bleeding, and acute kidney injury stage 2/3 were lower, whereas those of permanent pacemaker implantation and moderate/severe paravalvular leak were higher after TAVR versus SAVR. There were no significant differences between TAVR versus SAVR for major vascular complications, endocarditis, aortic valve re-intervention, and New York Heart Association functional class ≥II.

Conclusions: In this meta-analysis of RCTs comparing TAVR versus SAVR in low-risk patients, TAVR was associated with significantly lower risk of all-cause death and cardiovascular death at 1 year. These findings suggest that TAVR may be the preferred option over SAVR in low-risk patients with severe AS who are candidates for bioprosthetic AVR.
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http://dx.doi.org/10.1016/j.jacc.2019.06.076DOI Listing
September 2019

Ventricular stroke work and vascular impedance refine the characterization of patients with aortic stenosis.

Sci Transl Med 2019 09;11(509)

Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA 02142, USA.

Aortic stenosis (AS) management is classically guided by symptoms and valvular metrics. However, the natural history of AS is dictated by coupling of the left ventricle, aortic valve, and vascular system. We investigated whether metrics of ventricular and vascular state add to the appreciation of AS state above valve gradient alone. Seventy patients with severe symptomatic AS were prospectively followed from baseline to 30 days after transcatheter aortic valve replacement (TAVR). Quality of life (QOL) was assessed using the Kansas City Cardiomyopathy Questionnaire. Left ventricular stroke work (SW) and vascular impedance spectrums were calculated noninvasively using in-house models based on central blood pressure waveforms, along with hemodynamic parameters from echocardiograms. Patients with higher preprocedural SW and lower vascular impedance were more likely to experience improved QOL after TAVR. Patients fell into two categories: those who did and those who did not exhibit increase in blood pressure after TAVR. In patients who developed hypertension (19%), vascular impedance increased and SW remained unchanged (impedance at zeroth harmonic: , from 3964.4 to 4851.8 dyne·s/cm, = 0.039; characteristic impedance: , from 376.2 to 603.2 dyne·s/cm, = 0.033). SW dropped only in patients who did not develop new hypertension after TAVR (from 1.58 to 1.26 J; < 0.001). Reduction in valvular pressure gradient after TAVR did not predict change in SW ( = 0.213; = 0.129). Reduction of SW after TAVR may be an important metric in management of AS, rather than relying solely on the elimination of transvalvular pressure gradients.
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http://dx.doi.org/10.1126/scitranslmed.aaw0181DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7401937PMC
September 2019

Clinical impact of post procedural mitral regurgitation after transcatheter aortic valve replacement.

Int J Cardiol 2020 01 1;299:215-221. Epub 2019 Aug 1.

Cardiology Division, Tel Aviv Sourasky Medical Center, Sackler faculty of Medicine, Tel Aviv, Israel. Electronic address:

Background: While the impact of mitral regurgitation (MR) prior to transcatheter aortic valve replacement (TAVR) has been intensively studied, the implications of post-procedural MR on outcome are unknown. We investigated the clinical and physiological impact of significant MR after TAVR.

Methods: Clinical and echocardiographic data of 486 patients who underwent TAVR between March 2009 and December 2014 were evaluated. Clinical endpoints included overall mortality and combined endpoint of mortality, heart failure re-hospitalization and new atrial fibrillation. Echocardiographic parameters were analyzed at baseline, 30-day and 6-month after TAVR.

Results: MR severity improved in 25%, worsened in 19% and did not change in 56% of patients 30-days post TAVR (p = 0.3). Post TAVR MR grade ≥ moderate was present in 16.1%. Predictive accuracy of post TAVR MR was low (AUC = 0.63). Median follow-up was 4.3 years (interquartile range, 2.5 to 6.1). Post TAVR MR grade ≥ moderate was associated with increased mortality and combined cardiac events (p = 0.013 and p < 0.001) even when adjusted for all clinical and echo parameters and when analyzed with propensity score matching. In patients with MR ≥ moderate, LV filling pressure and RV hemodynamics worsened 6 months post TAVR, while improving in patients with less significant post procedural MR.

Conclusion: Post procedural, but not pre-procedural MR grade ≥ moderate was independently associated with mortality and adverse cardiac events after TAVR. Significant MR post TAVR resulted in adverse LV and RV remodeling and poor hemodynamic. Our study strengthens the rational for initiating early treatment to reduce post TAVR MR.
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http://dx.doi.org/10.1016/j.ijcard.2019.07.092DOI Listing
January 2020

Outcomes Following Urgent/Emergent Transcatheter Aortic Valve Replacement: Insights From the STS/ACC TVT Registry.

JACC Cardiovasc Interv 2018 06 11;11(12):1175-1185. Epub 2018 Mar 11.

Division of Cardiology, Brown University, Providence, Rhode Island. Electronic address:

Objectives: The authors sought to examine outcomes and identify independent predictors of mortality among patients undergoing urgent/emergent transcatheter aortic valve replacement (TAVR).

Background: Data on urgent/emergent TAVR as a rescue therapy for decompensated severe aortic stenosis (AS) are limited.

Methods: The Society of Thoracic Surgeons and the American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry linked with Centers for Medicare & Medicaid Services claims was used to identify patients who underwent urgent/emergent versus elective TAVR between November 2011 and June 2016. Outcomes assessed were device success rate, in-hospital major adverse events, and 30-day and 1-year mortality. Independent predictors of mortality after urgent/emergent TAVR were examined.

Results: Of 40,042 patients who underwent TAVR, 3,952 (9.9%) were urgent/emergent (median STS PROM score 11.8 [interquartile range: 7.6 to 17.9]). Device success rate was statistically lower, but not clinically different after urgent/emergent versus elective TAVR (92.6% vs. 93.7%; p = 0.007). Rates of major and/or life-threatening bleeding, major vascular complications, myocardial infarction, stroke, new permanent pacemaker placement, conversion to SAVR, and paravalvular regurgitation were similar between the 2 groups. Compared with elective TAVR, patients undergoing urgent/emergent TAVR had higher rates of acute kidney injury and/or new dialysis (8.2% vs. 4.2%; p < 0.001), 30-day mortality (8.7% vs. 4.3%, adjusted hazard ratio: 1.28, 95% confidence interval: 1.10 to 1.48), and 1-year mortality (29.1% vs. 17.5%, adjusted hazard ratio: 1.20, 95% confidence interval: 1.10 to 1.31). In patients undergoing urgent/emergent TAVR, non-femoral access and cardiopulmonary bypass were associated with increased risk, whereas use of balloon-expandable valve was associated with decreased risk of 30-day and 1-year mortality.

Conclusions: Urgent/emergent TAVR is feasible with acceptable outcomes and may be a reasonable option in a selected group of patients with severe AS.
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http://dx.doi.org/10.1016/j.jcin.2018.03.002DOI Listing
June 2018

Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Prior Coronary Artery Bypass Grafting: Trends in Utilization and Propensity-Matched Analysis of In-Hospital Outcomes.

Circ Cardiovasc Interv 2018 04;11(4):e006179

From the Division of Cardiology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (T.G., C.C.T., G.W., M.J.G.); Division of Cardiology, Massachusetts General Hospital, Boston (S.K., I.I., S.E.); Division of Cardiology, Warren Alpert Medical School, Brown University, Providence, RI (D.K., H.D.A., J.D.A.,); Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (K.G., C.S.R.); Division of Cardiovascular Medicine, Case Western Reserve University School of Medicine, Cleveland, OH (A.K.); Division of Cardiology, New York University Langone Medical Center (P.A.V.); Division of Cardiology, Ronald Reagan-UCLA Medical Center, Los Angeles, CA (G.C.F); Houston Methodist DeBakey Heart and Vascular Center, Houston Methodist Hospital, TX (N.S.K.); and Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, MA (D.L.B.).

Background: A significant proportion of patients requiring aortic valve replacement (AVR) have undergone prior coronary artery bypass grafting (CABG). Reoperative heart surgery is associated with increased risk. Data on relative utilization and comparative outcomes of transcatheter (TAVR) versus surgical AVR (SAVR) in patients with prior CABG are limited.

Methods And Results: We queried the 2012 to 2014 National Inpatient Sample databases to identify isolated AVR hospitalizations in adults with prior CABG. In-hospital outcomes of TAVR versus SAVR were compared using propensity-matched analysis. Of 147 395 AVRs, 15 055 (10.2%) were in patients with prior CABG. The number of TAVRs in patients with prior CABG increased from 1615 in 2012 to 4400 in 2014, whereas the number of SAVRs decreased from 2285 to 1895 (<0.001). There were 3880 records in each group in the matched cohort. Compared with SAVR, TAVR was associated with similar in-hospital mortality (2.3% versus 2.4%; =0.71) but lower incidence of myocardial infarction (1.5% versus 3.4%; <0.001), stroke (1.4% versus 2.7%; <0.001), bleeding complications (10.6% versus 24.6%; <0.001), and acute kidney injury (16.2% versus 19.3%; <0.001). Requirement for prior permanent pacemaker was higher in the TAVR cohort, whereas the incidence of vascular complications and acute kidney injury requiring dialysis was similar in the 2 groups. Average length of stay was shorter in patients undergoing TAVR.

Conclusions: TAVR is being increasingly used as the preferred modality of AVR in patients with prior CABG. Compared with SAVR, TAVR is associated with similar in-hospital mortality but lower rates of in-hospital complications in this important subset of patients.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.117.006179DOI Listing
April 2018

Transapical Transcatheter Aortic Valve Replacement Is Associated With Increased Cardiac Mortality in Patients With Left Ventricular Dysfunction: Insights From the PARTNER I Trial.

JACC Cardiovasc Interv 2017 12;10(23):2414-2422

Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.

Objectives: The authors sought to evaluate the impact of transapical (TA) transcatheter aortic valve replacement (TAVR) on mortality, left ventricular (LV) ejection fraction (LVEF) improvement, and functional recovery in patients with LV dysfunction.

Background: LV injury inherent to TA access for structural heart disease interventions may be particularly detrimental to the LV, functional recovery, and survival in patients with LV dysfunction.

Methods: The study included patients enrolled within the PARTNER I (Placement of Aortic Transcatheter Valves) trial that underwent transfemoral (TF) or TA TAVR. Analyses of clinical outcomes were stratified by the presence of baseline LV dysfunction (LVEF<50%) and adjusted for the propensity of receiving TA TAVR.

Results: Of 2,084 subjects, 1,057 underwent TA TAVR. TA access was associated with increased 2-year all-cause mortality in those with (adjusted hazard ratio [HR]: 1.52; 95% confidence interval [CI]: 1.12 to 2.07; p = 0.008) and without (HR: 1.38; 95% CI: 1.10 to 1.74; p = 0.006) LV dysfunction. TA TAVR portended increased 2-year cardiac mortality in subjects with LVEF<50% (HR: 1.92; 95% CI: 1.21 to 3.05; p = 0.006), but not with LVEF≥50% (HR: 1.29; 95% CI: 0.87 to 1.90; p = 0.21). In those with LVEF<50%, greater improvements in LVEF (TF-TA difference +4.04%, 95% CI: 2.39% to 5.69%; p < 0.0001) and 6-min walk distance (TF-TA difference +45.1 m, 95% CI: 18.4 to 71.9 m; p = 0.001) occurred within 30 days after TF versus TA TAVR.

Conclusions: Compared with TF TAVR, TA TAVR is associated with a disproportionate risk of cardiac mortality in patients with LV dysfunction and with delayed and less robust improvement in LV function and overall functional status. Caution is warranted when considering TA access for structural heart disease interventions, particularly in patients with LV dysfunction. (Placement of Aortic Transcatheter Valves [PARTNER]; NCT00530894).
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http://dx.doi.org/10.1016/j.jcin.2017.09.023DOI Listing
December 2017

Transcatheter Aortic Valve Replacement: Outcomes, Indications, Complications, and Innovations.

Curr Treat Options Cardiovasc Med 2017 Sep 22;19(10):81. Epub 2017 Sep 22.

Cardiology Division, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, GRB8-852E, Boston, MA, 02114, USA.

Opinion Statement: Transcatheter aortic valve replacement (TAVR) has become the standard of care for the treatment of severe aortic stenosis in individuals who are at prohibitive surgical risk and presents a viable alternative to surgery in selected patients who are at high operative risk. To date, outcomes from the PARTNER (Placement of AoRtic TraNscathetER Valve) and Medtronic CoreValve® US Pivotal trials continue to show the benefits of TAVR in these high-risk subgroups out to 5 and 3 years, respectively (as reported by Mack et al. Lancet. 85:2477-2484 2015; Kapadia et al. Lancet. 385:2485-2491 2015; Deeb et al. J Am Coll Cardiol. 67:2565-2574 2016). Furthermore, the recent release of the PARTNER-2 and SURTAVI trial results among other international data suggest that clinical outcomes for intermediate risk patients may be promising for TAVR compared to surgical aortic valve replacement (SAVR) (as reported by Leon et al. N Engl J Med. 374:1609-1620 2016; Reardon et al. N Engl J Med. 376:1321-1331 2017). However, several questions persist regarding TAVR-specific complications as well as long-term durability. Paravalvular regurgitation, permanent pacemaker implantation, stroke, vascular access injury, and renal failure in post-TAVR patients remain adversaries in the quest to perfect this groundbreaking, game-changing technology (as reported by Khatri et al. Ann Intern Med. 158:35-46 2013). In this review, we provide an up-to-date synopsis of results from landmark clinical trials that cumulatively attest to the comparability of TAVR to best medical therapy and SAVR in extreme-risk, high-risk, and intermediate-risk patient populations. We continue with a review of studies that seek to compare transcatheter vs. surgical valve implantation in lower-risk subgroups. We also introduce ongoing efforts to optimize the peri-procedural management of TAVR and conclude with a presentation of management strategies and new generation valve platforms that seek to address some of the current limitations of transcatheter valve implantation.
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http://dx.doi.org/10.1007/s11936-017-0580-0DOI Listing
September 2017

Outcomes of hemodynamic support with Impella in very high-risk patients undergoing balloon aortic valvuloplasty: Results from the Global cVAD Registry.

Int J Cardiol 2017 Aug 22;240:120-125. Epub 2017 Mar 22.

Henry Ford Hospital, Detroit, MI, United States.

Background: Reports on the role of hemodynamic support devices in patients with severe aortic stenosis (AS) and left ventricular (LV) dysfunction undergoing balloon aortic valvuloplasty (BAV) are limited.

Methods: Patients were identified from the cVAD registry, an ongoing multicenter voluntary registry at selected sites in North America that have used Impella in >10 patients.

Results: A total of 116 patients with AS who underwent BAV with Impella support were identified. Mean age was 80.41±9.03years and most patients were male. Mean STS score was 18.77%±18.32, LVEF was 27.14%±16.07, and 42% underwent concomitant PCI. In most cases Impella was placed electively prior to BAV, whereas 26.7% were placed as an emergency. The two groups had similar baseline characteristics except for higher prevalence of CAD and lower LVEF in the elective group, and higher STS score in the emergency group. Elective strategy was associated higher 1-year survival compared to emergency placement (56% vs. 29.2%, p=0.003). One-year survival was higher when BAV was used as a bridge to definitive therapy as opposed to palliative treatment (90% vs. 28%, p<0.001). On multivariate analysis, STS score and aim of BAV (bridge to definitive therapy vs. palliative indication) were independent predictors of mortality.

Conclusion: In this large cohort of patients with AS and severe LV dysfunction undergoing BAV, our results demonstrates feasibility and promising long-term outcomes using elective Impella support with the intention to bridge to a definitive therapy.
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http://dx.doi.org/10.1016/j.ijcard.2017.03.071DOI Listing
August 2017

Utilization and outcomes of transcatheter aortic valve replacement in the United States shortly after device approval.

Catheter Cardiovasc Interv 2017 Nov 22;90(5):830-838. Epub 2017 Mar 22.

Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.

Objective: The objective of this study was to assess the national uptake of TAVR, associated in-hospital outcomes, and the effect of procedural experience on outcomes in the first two years following device approval.

Background: Transcatheter aortic valve replacement (TAVR) is a newly established therapy for high-risk patients with severe aortic stenosis. Evaluating the manner in which TAVR has disseminated into real-world practice is essential for understanding its impact on population health.

Methods And Results: We identified patients undergoing TAVR from the National Inpatient Sample from January 2012 through December 2013. During this period, an estimated 21,185 cases were performed in the United States. Mean age was 81.1 years, 50.8% were male, 86.5% were Caucasian, and 89.6% were Medicare patients. The number of TAVRs performed and of hospitals performing the procedure nationally grew linearly throughout the study period. The most frequent complications included bleeding (26.9%), respiratory failure (19.3%), and renal/metabolic issues (17.2%). Median hospital length of stay was 6 days (IQR 4-10). In-hospital mortality was estimated to be 4.9%. A majority of cases were performed in large (80.8%) and in urban teaching (87%) hospitals. In the first year post-market approval, prior institutional experience with TAVR was associated with significantly reduced risk-adjusted, in-hospital mortality (OR 0.82 per 25 additional TAVRs performed, CI 0.70-0.951, P = 0.009).

Conclusions: Following device approval, the number of TAVRs and hospitals performing TAVR grew dramatically. Procedural complications were frequent and in-hospital mortality was approximately 4.9%. Finally, increased procedural experience was strongly associated with a reduction in inpatient mortality. © 2017 Wiley Periodicals, Inc.
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http://dx.doi.org/10.1002/ccd.27018DOI Listing
November 2017

Metabolite Profiles Predict Acute Kidney Injury and Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement.

J Am Heart Assoc 2016 Mar 15;5(3):e002712. Epub 2016 Mar 15.

Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA Cardiovascular Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA

Background: Acute kidney injury (AKI) occurs commonly after transcatheter aortic valve replacement (TAVR) and is associated with markedly increased postoperative mortality. We previously identified plasma metabolites predictive of incident chronic kidney disease, but whether metabolite profiles can identify those at risk of AKI is unknown.

Methods And Results: We performed liquid chromatography-mass spectrometry-based metabolite profiling on plasma from patients undergoing TAVR and subjects from the community-based Framingham Heart Study (N=2164). AKI was defined by using the Valve Academic Research Consortium-2 criteria. Of 44 patients (mean age 82±9 years, 52% female) undergoing TAVR, 22 (50%) had chronic kidney disease and 9 (20%) developed AKI. Of 85 metabolites profiled, we detected markedly concordant cross-sectional metabolic changes associated with chronic kidney disease in the hospital-based TAVR and Framingham Heart Study cohorts. Baseline levels of 5-adenosylhomocysteine predicted AKI after TAVR, despite adjustment for baseline glomerular filtration rate (odds ratio per 1-SD increase 5.97, 95% CI 1.62-22.0; P=0.007). Of the patients who had AKI, 6 (66.7%) subsequently died, compared with 3 (8.6%) deaths among those patients who did not develop AKI (P=0.0008) over a median follow-up of 7.8 months. 5-adenosylhomocysteine was predictive of all-cause mortality after TAVR (hazard ratio per 1-SD increase 2.96, 95% CI 1.33-6.58; P=0.008), independent of baseline glomerular filtration rate.

Conclusions: In an elderly population with severe aortic stenosis undergoing TAVR, metabolite profiling improves the prediction of AKI. Given the multifactorial nature of AKI after TAVR, metabolite profiles may identify those patients with reduced renal reserve.
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http://dx.doi.org/10.1161/JAHA.115.002712DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4943248PMC
March 2016

Percutaneous Mitral Valve Edge-to-Edge Repair for Degenerative Mitral Regurgitation.

Curr Treat Options Cardiovasc Med 2015 Jul;17(7):389

Cardiology Division, Department of Medicine, Harvard Medical School, Massachusetts General Hospital, 55 Fruit Street, Yawkey 5B, Boston, MA, 02114, USA,

Opinion Statement: Surgical mitral valve (MV) repair remains the gold standard to treat patients with significant degenerative mitral regurgitation (DMR). Medical therapy was the only option for patients found to be not appropriate for MV surgery until the development of percutaneous/transcatheter MV repair options that now allow to reduce MR less invasively and safely. This article discusses the basic mechanisms of MR and the rationale for MR intervention and offers a detailed review on percutaneous/transcatheter MV repair with the MitraClip.
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http://dx.doi.org/10.1007/s11936-015-0389-7DOI Listing
July 2015

Incidence and Predictors of Pacemaker Implantation in Patients Undergoing Transcatheter Aortic Valve Replacement.

Pacing Clin Electrophysiol 2015 Jul 28;38(7):878-86. Epub 2015 May 28.

Heart Center, Massachusetts General Hospital, Boston, Massachusetts.

Background: Transcatheter aortic valve replacement (TAVR) has emerged as an alternative treatment for patients with symptomatic aortic stenosis who are at high risk for surgical aortic valve replacement. The development of conduction abnormalities is a major complication in the postprocedural period of TAVR.

Objectives: The objective of this study was to investigate the development of postprocedural conduction abnormalities and the requirement of permanent pacemaker (PPM) implantation in patients undergoing TAVR.

Methods: Data from 137 consecutive patients who underwent TAVR (Edwards SAPIEN valve, Edwards Lifesciences, Irvine, CA, USA) between June 2008 and October 2012 were reviewed. Patients with prior history of PPM (n = 27) were excluded. The role of various predictors for pacemaker implantation after TAVR, including the valve index (calculated as [valve size/left ventricular outflow tract diameter] × 100) was investigated.

Results: A total of 31/110 (28.2%) patients required implantation of a PPM after TAVR. The median time to implantation of a PPM was 5 days after the procedure. The development of postprocedural complete heart block was the most common indication for implantation of a PPM (16/31; 51.6%). On multivariate analysis, the presence of preexisting right bundle branch block (RBBB) was found to be a strong predictor of PPM implantation after TAVR (adjusted odds ratio: 4.87; 95% confidence interval: 1.29-18.46, P = 0.020). Using the receiver operated curve analysis, a cut-off value of valve index of 128 was found to be a strong predictor for PPM implantation with a sensitivity of 73% and specificity of 61% (c statistic = 0.68).

Conclusions: This study identified the presence of prior RBBB and a valve index of 128 as important risk factors for PPM implantation after TAVR. A larger implanted valve size relative to left ventricular outflow tract diameter leads to a greater compression of the intrinsic conduction system, increasing the need for pacemaker placement.
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http://dx.doi.org/10.1111/pace.12653DOI Listing
July 2015

Proteomic signatures of serum albumin-bound proteins from stroke patients with and without endovascular closure of PFO are significantly different and suggest a novel mechanism for cholesterol efflux.

Clin Proteomics 2015 13;12(1). Epub 2015 Jan 13.

Clinical Proteomics Research Center and Cardio-Neurology Clinic, Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA USA.

Background: The anatomy of PFO suggests that it can allow thrombi and potentially harmful circulatory factors to travel directly from the venous to the arterial circulation - altering circulatory phenotype. Our previous publication using high-resolution LC-MS/MS to profile protein and peptide expression patterns in plasma showed that albumin was relatively increased in donor samples from PFO-related than other types of ischemic strokes. Since albumin binds a host of molecules and acts as a carrier for lipoproteins, small molecules and drugs, we decided to investigate the albumin-bound proteins (in a similar sample cohort) in an effort to unravel biological changes and potentially discover biomarkers related to PFO-related stroke and PFO endovascular closure.

Methods: The method used in this study combined albumin immuno-enrichment with high resolution LC-MS in order to specifically capture and quantify the albumin-bound proteins. Subsequently, we measured cholesterol and HDL in a larger, separate cohort of PFO stroke patients, pre and post closure.

Results: The results demonstrated that a number of proteins were specifically associated with albumin in samples with and without endovascular closure of the PFO, and that the protein profiles were very different. Eight proteins, typically associated with HDL were common to both sample sets and quantitatively differently abundant. Pathway analysis of the MS results suggested that enhanced cholesterol efflux and reduced lipid oxidation were associated with PFO closure. Measurement of total cholesterol and HDL in a larger cohort of PFO closure samples using a colorimetric assay was consistent with the proteomic predictions.

Conclusions: The collective data presented in this study demonstrate that analysis of albumin-bound proteins could provide a valuable tool for biomarker discovery on the effects of PFO endovascular closure. In addition, the results suggest that PFO endovascular closure can potentially have effects on HDL, cholesterol and albumin-bound ApoA-I abundance, therefore possibly providing benefits in cardioprotective functions.
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http://dx.doi.org/10.1186/1559-0275-12-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4305391PMC
February 2015

Transcatheter aortic valve replacement and standard therapy in inoperable patients with aortic stenosis and low EF.

Heart 2015 Mar 13;101(6):463-71. Epub 2015 Jan 13.

Duke Clinical Research Institute/Duke University Medical Center, Durham, North Carolina, USA.

Objectives: The aims of this study were to evaluate the effect of left ventricular (LV) dysfunction on clinical outcomes after transcatheter aortic valve replacement (TAVR) and standard therapy for severe aortic stenosis (AS) and to assess LV ejection fraction (LVEF) recovery and its impact on subsequent clinical outcomes.

Methods: Cohort B of the Placement of AoRtic TraNscathetER Valves trial randomised 342 inoperable patients with severe AS to TAVR or standard therapy. We defined LV dysfunction as an LVEF <50% and LVEF improvement as an absolute increase in LVEF ≥10% at 30 days.

Results: Baseline LV dysfunction did not affect survival after TAVR but was associated with increased cardiac mortality at 1 year with standard therapy (59.3% vs 45.8% with normal LVEF; HR=1.71 (95% CI 1.08 to 2.71); p=0.02). In those with LV dysfunction, LVEF improvement occurred in 48.7% and 30.4% of TAVR and standard therapy patients, respectively (p=0.08), and was independently predicted by relative wall thickness and receipt of TAVR. LVEF improvement with standard therapy portended reduced all-cause mortality at 1 year (28.6% vs 65.6% without LVEF improvement; HR=0.32 (95% CI 0.11 to 0.93); p=0.03) but not at 2 years.

Conclusions: In inoperable patients with severe AS, mild-to-moderate LV dysfunction is associated with higher cardiac mortality with standard therapy but not TAVR. A subset of patients undergoing standard therapy with LV dysfunction demonstrates LVEF improvement and favourable 1-year but not 2-year survival. TAVR improves survival and should be considered the standard of care for inoperable patients with AS and LVEF >20%.

Trial Registration Number: ClinicalTrials.gov Unique Identifier #NCT00530894.
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http://dx.doi.org/10.1136/heartjnl-2014-306737DOI Listing
March 2015

Impact of atrial fibrillation on outcomes in patients who underwent transcatheter aortic valve replacement.

Am J Cardiol 2015 Jan 29;115(2):220-6. Epub 2014 Oct 29.

Heart Center, Massachusetts General Hospital, Boston, Massachusetts. Electronic address:

Transcatheter aortic valve replacement (TAVR) has emerged as an alternative treatment for surgical high-risk patients with severe aortic stenosis. The aim of this study was to determine the impact of atrial fibrillation (AF) on procedural outcomes. Data from 137 patients who underwent TAVR using Edwards SAPIEN valve were reviewed. The predictors of new-onset atrial fibrillation (NOAF) after the procedure were analyzed. In addition, the post-TAVR clinical outcomes and adverse events were compared according to the presence and absence of preprocedural and postprocedural AF. Previous AF was present in 49% of the patients who underwent TAVR. After the procedure, NOAF was detected in 21% of patients, and the cumulative incidence of post-TAVR AF was 60%. After TAVR, 50% of all the episodes of NOAF occurred in the initial 24 hours after the procedure. Transapical approach was observed to an important predictor of NOAF (adjusted odds ratio [OR] 5.05, 95% confidence interval [CI] 1.40 to 18.20, p = 0.013). The composite outcome of all-cause mortality, stroke, vascular complications, and repeat hospitalization in 1 month after TAVR was significantly higher in patients with previous AF (33 of 67 vs 19 of 70, adjusted OR 2.60, 95% CI 1.22 to 5.54, p = 0.013) compared with patients who did not have previous AF. The presence of post-TAVR AF led to a prolongation in the duration of intensive care unit stay by an average of 70 hours (95% CI 25 to 114.7 hours, p = 0.002). Similarly, post-TAVR AF also led to the prolongation in the hospital stay by an average of 6.7 days (95% CI 4.69 to 8.73 days, p <0.0005). In conclusion, our study demonstrates that the presence of AF before TAVR is an important predictor of the composite end point of all-cause mortality, stroke, vascular complications, and repeat hospitalization in 1 month after the procedure. AF after TAVR is more likely to be encountered with the transapical approach and is associated with a prolongation of intensive care unit and hospital stay.
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http://dx.doi.org/10.1016/j.amjcard.2014.10.027DOI Listing
January 2015

The aortic valve calcium nodule score (AVCNS) independently predicts paravalvular regurgitation after transcatheter aortic valve replacement (TAVR).

J Cardiovasc Comput Tomogr 2014 Mar-Apr;8(2):131-40. Epub 2014 Jan 11.

Cardiac Imaging, Department of Radiology, Massachusetts General Hospital, Boston, MA, USA; Department of Radiology, University of Texas Southwestern Medical Center, Dallas, TX. Electronic address:

Background: Paravalvular regurgitation (PVR) is an important predictor of mortality after transcatheter aortic valve replacement (TAVR). Aortic valve (AV) calcification is strongly associated with PVR.

Objectives: This study proposes a new metric to quantify AV total calcium burden and its composition in large calcium nodules (CNs) and explores its relation with PVR after TAVR.

Methods: In 133 patients that underwent TAVR, calcium burden of the AV was quantified with multidetector row CT as calcium mass. Each CN was characterized. The AV CN score (AVCNS) was defined as AV calcium mass × mass of the largest CN. PVR was assessed with echocardiography at 1 month. Logistic regression analysis was conducted to identify predictors of PVR.

Results: Mean age was 84.1 ± 7.6 years (56% women). TAVR access was transapical in 56%. Procedural success was achieved in 92%. In-hospital mortality was 5%. At follow-up, the prevalence of absent/trace, mild, moderate, and severe PVR was 58%, 31%, 11%, and 0%, respectively. The only independent predictors of at least mild PVR were AVCNS (odds ratio [OR], 2.269; 95% CI, 1.433-3.593; P < .001), number of CNs on aortic annulus (OR, 1.822; 95% CI, 1.137-2.921; P = .013), and aortic annulus area (OR, 1.112; 95% CI, 1.010-1.223; P = .030). This model showed an area under the curve of 0.895 (95% CI, 0.830-0.960) for PVR prediction.

Conclusions: AVCNS, a variable that comprises the total burden of AV calcification as well as calcification agglomeration in form of large nodules, is a novel and powerful independent predictor of PVR after TAVR.
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http://dx.doi.org/10.1016/j.jcct.2013.12.013DOI Listing
November 2014

Feasibility of C-arm computed tomography for transcatheter aortic valve replacement planning.

J Cardiovasc Comput Tomogr 2014 Jan-Feb;8(1):33-43. Epub 2014 Jan 8.

Cardiac Imaging, Department of Radiology, Massachusetts General Hospital, 55 Fruit Street, GRB-295, Boston, MA 02114, USA; Department of Radiology, University of Texas Southwestern Medical Center, Dallas, TX, USA. Electronic address:

Background: The C-arm used for fluoroscopy during transcatheter aortic valve replacement (TAVR) may also be used to acquire 3-dimensional data sets similar to multidetector row CT (MDCT).

Objective: The aim of this study was to evaluate the feasibility of C-arm CT (CACT) for aortic annulus and root (AoA/R) measurements in TAVR planning compared with MDCT.

Methods: Twenty patients who were studied for TAVR underwent MDCT and CACT. Two independent observers measured predicted perpendicular projection to annular plane, diameters of the aortic annulus, sinus of Valsalva, sinotubular junction and ascending aorta, distance of coronary ostia to annular plane, sinus of Valsalva height, and leaflet length. Correlation between MDCT and CACT and interobserver variability were analyzed.

Results: MDCT and CACT showed strong correlation for all the measurements of the AoA/R (r ranging from 0.62 to 0.94; P between <.001 and .042) and also for the predicted perpendicular projection (left/right anterior oblique: r = 0.96, P = .002; cranial/caudal: r = 0.83, P = .043). Interobserver variability analysis showed disagreement for the measurements of the aortic annulus structures with CACT (intraclass correlation coefficient [ICC], <0.25) but not for the rest of the variables (ICC between 0.47 and 0.97). MDCT showed no interobserver variability for all the measurements (ICC between 0.45 and 0.93).

Conclusions: CACT showed strong correlation with MDCT for the measurement of all AoA/R structures. However, CACT showed also important interobserver variability for the assessment of the aortic annulus. Therefore, valve sizing may not be reliably performed on the basis of CACT measurements alone.
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http://dx.doi.org/10.1016/j.jcct.2013.12.001DOI Listing
October 2014

The echo score revisited: Impact of incorporating commissural morphology and leaflet displacement to the prediction of outcome for patients undergoing percutaneous mitral valvuloplasty.

Circulation 2014 Feb 26;129(8):886-95. Epub 2013 Nov 26.

Cardiac Ultrasound Lab, Massachusetts General Hospital, Harvard Medical School, Boston, MA (M.C.P.N., T.C.T., M.D.H., A.E.W., J.H.); School of Medicine, Federal University of Minas Gerais, Belo Horizonte, MG, Brazil (M.C.P.N.); Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA (S.E., R.d.L., R.M., I.C.-G., I.I., I.F.P.); and Massachusetts General Hospital Biostatistics Center, Harvard Medical School, Boston, MA (H.Z.).

Background: Current echocardiographic scoring systems for percutaneous mitral valvuloplasty (PMV) have limitations. This study examined new, more quantitative methods for assessing valvular involvement and the combination of parameters that best predicts immediate and long-term outcome after PMV.

Methods And Results: Two cohorts (derivation n=204 and validation n=121) of patients with symptomatic mitral stenosis undergoing PMV were studied. Mitral valve morphology was assessed by using both the conventional Wilkins qualitative parameters and novel quantitative parameters, including the ratio between the commissural areas and the maximal excursion of the leaflets from the annulus in diastole. Independent predictors of outcome were assigned a points value proportional to their regression coefficients: mitral valve area ≤1 cm(2) (2), maximum leaflets displacement ≤12 mm (3), commissural area ratio ≥1.25 (3), and subvalvular involvement (3). Three risk groups were defined: low (score of 0-3), intermediate (score of 5), and high (score of 6-11) with observed suboptimal PMV results of 16.9%, 56.3%, and 73.8%, respectively. The use of the same scoring system in the validation cohort yielded suboptimal PMV results of 11.8%, 72.7%, and 87.5% in the low-, intermediate-, and high-risk groups, respectively. The model improved risk classification in comparison with the Wilkins score (net reclassification improvement 45.2%; P<0.0001). Long-term outcome was predicted by age and postprocedural variables, including mitral regurgitation, mean gradient, and pulmonary pressure.

Conclusions: A scoring system incorporating new quantitative echocardiographic parameters more accurately predicts outcome following PMV than existing models. Long-term post-PMV event-free survival was predicted by age, degree of mitral regurgitation, and postprocedural hemodynamic data.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.113.001252DOI Listing
February 2014

Long-term experience and outcomes with transcatheter closure of patent foramen ovale.

JACC Cardiovasc Interv 2013 Nov;6(11):1176-83

Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard, Medical School, Boston, Massachusetts.

Objectives: This study sought to examine the frequency of indications for and the immediate and long-term clinical outcomes of transcatheter closure of patent foramen ovale (PFO).

Background: Transcatheter PFO closure is commonly performed for several indications, including cryptogenic stroke, despite conflicting data regarding the efficacy of this intervention.

Methods: We report the outcomes of 800 consecutive patients (52% male, 50 ± 14 years of age) who underwent PFO closure at our institution after multidisciplinary evaluation over a 16-year period.

Results: Indications for closure included cryptogenic cerebrovascular event (94%), hypoxemia (2%), peripheral embolism (3%), and migraine headaches (2%). Procedural success was 99% with effective closure obtained in 93% of patients. At a mean follow-up of 42.7 ± 33.4 months, 21 patients suffered a recurrent ischemic neurologic event (12 strokes, and 9 transient ischemic attacks) for an incidence rate of 0.79 events per 100 person-years and freedom from recurrent events of 91.6% at 10 years. There was no device-based difference in the rate of recurrent ischemic neurologic events (p = 0.82). Only Eustachian valve prominence (hazard ratio: 9.04; 95% confidence interval: 2.07 to 39.44; p = 0.0034) was associated with recurrent neurologic events.

Conclusions: Transcatheter PFO closure is safe and feasible in patients with several clinical indications. The long-term efficacy of this intervention in patients with paradoxical embolism appears superb in this observational study. Carefully selected patients with features suggestive of paradoxical embolism are the most likely to benefit from PFO closure and should be the focus of future investigation.
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http://dx.doi.org/10.1016/j.jcin.2013.06.013DOI Listing
November 2013

Outcomes of transcatheter and surgical aortic valve replacement in high-risk patients with aortic stenosis and left ventricular dysfunction: results from the Placement of Aortic Transcatheter Valves (PARTNER) trial (cohort A).

Circ Cardiovasc Interv 2013 Dec 12;6(6):604-14. Epub 2013 Nov 12.

From the Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston (S.E., I.F.P., I.I., J.N.B., J.J.P.); Harvard Clinical Research Institute, Boston, MA (S.E.); Columbia University Medical Center/New York-Presbyterian Hospital and The Cardiovascular Research Foundation (T.M., I.H., S.K., M.B.L., A.J.K.); Department of Cardiovascular Medicine, Cleveland Clinic, OH (L.S.); Québec Heart and Lung Institute, Laval University, Québec, Canada (P.P.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (P.S.D.); Division of Cardiovascular Medicine, Stanford University School of Medicine, CA (W.F.F.); and Division of Cardiothoracic Surgery, Washington University, St. Louis, MO (H.S.M.).

Background: The Placement of Aortic Transcatheter Valves (PARTNER) trial demonstrated similar survival after transcatheter and surgical aortic valve replacement (TAVR and SAVR, respectively) in high-risk patients with symptomatic, severe aortic stenosis. The aim of this study was to evaluate the effect of left ventricular (LV) dysfunction on clinical outcomes after TAVR and SAVR and the impact of aortic valve replacement technique on LV function.

Methods And Results: The PARTNER trial randomized high-risk patients with severe aortic stenosis to TAVR or SAVR. Patients were stratified by the presence of LV ejection fraction (LVEF) <50%. All-cause mortality was similar for TAVR and SAVR at 30-days and 1 year regardless of baseline LV function and valve replacement technique. In patients with LV dysfunction, mean LVEF increased from 35.7±8.5% to 48.6±11.3% (P<0.0001) 1 year after TAVR and from 38.0±8.0% to 50.1±10.8% after SAVR (P<0.0001). Higher baseline LVEF (odds ratio, 0.90 [95% confidence interval, 0.86, 0.95]; P<0.0001) and previous permanent pacemaker (odds ratio, 0.34 [95% confidence interval, 0.15, 0.81]) were independently associated with reduced likelihood of ≥10% absolute LVEF improvement by 30 days; higher mean aortic valve gradient was associated with increased odds of LVEF improvement (odds ratio, 1.04 per 1 mm Hg [95% confidence interval, 1.01, 1.08]). Failure to improve LVEF by 30 days was associated with adverse 1-year outcomes after TAVR but not SAVR.

Conclusions: In high-risk patients with severe aortic stenosis and LV dysfunction, mortality rates and LV functional recovery were comparable between valve replacement techniques. TAVR is a feasible alternative for patients with symptomatic severe aortic stenosis and LV dysfunction who are at high risk for SAVR.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.113.000650DOI Listing
December 2013