Rishi Puri

Incidence, Timing, and Predictors of Valve Hemodynamic Deterioration After Transcatheter Aortic Valve Replacement: Multicenter Registry.

BACKGROUNDnScarce data exist on the incidence of and factors associated with valve hemodynamic deterioration (VHD) after transcatheter aortic valve replacement (TAVR).nnnOBJECTIVESnThis study sought to determine the incidence, timing, and predictors of VHD in a large cohort of patients undergoing TAVR.nnnMETHODSnThis multicenter registry included 1,521 patients (48% male; 80 ± 7 years of age) who underwent TAVR. Mean echocardiographic follow-up was 20 ± 13 months (minimum: 6 months). Echocardiographic examinations were performed at discharge, at 6 to 12 months, and yearly thereafter. Annualized changes in mean gradient (mm Hg/year) were calculated by dividing the difference between the mean gradient at last follow-up and the gradient at discharge by the time between examinations. VHD was defined as a ≥10 mm Hg increase in transprosthetic mean gradient during follow-up compared with discharge assessment.nnnRESULTSnThe overall mean annualized rate of transprosthetic gradient progression during follow-up was 0.30 ± 4.99 mm Hg/year. A total of 68 patients met criteria of VHD (incidence: 4.5% during follow-up). The absence of anticoagulation therapy at hospital discharge (p = 0.002), a valve-in-valve (TAVR in a surgical valve) procedure (p = 0.032), the use of a 23-mm valve (p = 0.016), and a greater body mass index (p = 0.001) were independent predictors of VHD.nnnCONCLUSIONSnThere was a mild but significant increase in transvalvular gradients over time after TAVR. The lack of anticoagulation therapy, a valve-in-valve procedure, a greater body mass index, and the use of a 23-mm transcatheter valve were associated with higher rates of VHD post-TAVR. Further prospective studies are required to determine whether a specific antithrombotic therapy post-TAVR may reduce the risk of VHD.

Transcatheter Therapies for Treating Tricuspid Regurgitation.

Tricuspid valve (TV) disease has been relatively neglected, despite the known association between severe tricuspid regurgitation (TR) and mortality. Few patients undergo isolated tricuspid surgery, which remains associated with high in-hospital mortality rates, particularly in patients with prior left-sided valve surgery. Patients with severe TR are often managed medically for years before TV repair or replacement. Current guidelines recommend TV repair in the presence of a dilated tricuspid annulus at the time of a left-sided valve surgical intervention, even if regurgitation is mild. This proposed algorithm aims to prevent the inevitable progression to severe TR and the need for a second surgical intervention. Recently, novel transcatheter treatment options were developed for treating patients with severe TR and right heart failure with prohibitive surgical risk. Here we describe currently available transcatheter treatment options for severe TR implanted at different levels: the junction between vena cavae and right atrium; the tricuspid annulus; or between TV leaflets, improving coaptation.

Predictors of Early Cerebrovascular Events in Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement

BACKGROUNDnIdentifying transcatheter aortic valve replacement (TAVR) patients at high risk for cerebrovascular events (CVE) is of major clinical relevance. However, predictors have varied across studies.nnnOBJECTIVESnThe purpose of this study was to analyze the predictors of 30-day CVE post-TAVR.nnnMETHODSnA systematic review of studies that reported the incidence of CVE post-TAVR while providing raw data for predictors of interest was performed. Data on study, patient, and procedural characteristics were extracted. Crude risk ratios (RRs) and 95% confidence intervals for each predictor were calculated.nnnRESULTSnSixty-four studies involving 72,318 patients (2,385 patients with a CVE within 30 days post-TAVR) were analyzed. Incidence of CVE ranged from 1% to 11% (median 4%) without significant differences between single and multicenter studies, or according to CVE adjudication availability. The summary RRs indicated lower risk for men (RR: 0.82; pxa0= 0.02) and higher risk for patients with chronic kidney disease (RR: 1.29; pxa0= 0.03) and with new-onset atrial fibrillation post-TAVR (RR:xa01.85; p = 0.005), and for procedures performed within the first half of center experience (RR: 1.55; pxa0=xa00.003). The use of balloon post-dilation tended to be associated with a higher risk of CVE (RR: 1.43; p = 0.07). Valve type (balloon-expandable vs. self-expandable, pxa0= 0.26) and approach (transfemoral vs. nontransfemoral, pxa0= 0.81) did not predict CVE.nnnCONCLUSIONSnFemale sex, chronic kidney disease, enrollment date, and new-onset atrial fibrillation were predictorsxa0of CVE post-TAVR. This study provides effect estimates to identify high-risk TAVR patients for early CVE,xa0providing possible guidance for tailored preventive strategies.

Transcatheter Valve-in-Valve and Valve-in-Ring for Treating Aortic and Mitral Surgical Prosthetic Dysfunction.

Bioprosthetic valve use has increased significantly. Considering their limited durability, there will remain an ongoing clinical need for repairing or replacing these prostheses in the future. The current standard of care for treating bioprosthetic valve degeneration involves redo open-heart surgery. However, repeat cardiac surgery may be associated with significant morbidity and mortality. With the rapid evolution of transcatheter heart valve therapies, the feasibility and safety of implanting a transcatheter heart valve within a failed tissue valve has been established. We review the historical perspective of transcatheter valve-in-valve therapy, as well as the main procedural challenges and clinical outcomes associated with this new less invasive treatment option.

Association Between Transcatheter Aortic Valve Replacement and Subsequent Infective Endocarditis and In-Hospital Death

IMPORTANCEnLimited data exist on clinical characteristics and outcomes of patients who had infective endocarditis after undergoing transcatheter aortic valve replacement (TAVR).nnnOBJECTIVEnTo determine the associated factors, clinical characteristics, and outcomes of patients who had infective endocarditis after TAVR.nnnDESIGN, SETTING, AND PARTICIPANTSnThe Infectious Endocarditis after TAVR International Registry included patients with definite infective endocarditis after TAVR from 47 centers from Europe, North America, and South America between June 2005 and October 2015.nnnEXPOSUREnTranscatheter aortic valve replacement for incidence of infective endocarditis and infective endocarditis for in-hospital mortality.nnnMAIN OUTCOMES AND MEASURESnInfective endocarditis and in-hospital mortality after infective endocarditis.nnnRESULTSnA total of 250 cases of infective endocarditis occurred in 20u202f006 patients after TAVR (incidence, 1.1% per person-year; 95% CI, 1.1%-1.4%; median age, 80 years; 64% men). Median time from TAVR to infective endocarditis was 5.3 months (interquartile range [IQR], 1.5-13.4 months). The characteristics associated with higher risk of progressing to infective endocarditis after TAVR was younger age (78.9 years vs 81.8 years; hazard ratio [HR], 0.97 per year; 95% CI, 0.94-0.99), male sex (62.0% vs 49.7%; HR, 1.69; 95% CI, 1.13-2.52), diabetes mellitus (41.7% vs 30.0%; HR, 1.52; 95% CI, 1.02-2.29), and moderate to severe aortic regurgitation (22.4% vs 14.7%; HR, 2.05; 95% CI, 1.28-3.28). Health care-associated infective endocarditis was present in 52.8% (95% CI, 46.6%-59.0%) of patients. Enterococci species and Staphylococcus aureus were the most frequently isolated microorganisms (24.6%; 95% CI, 19.1%-30.1% and 23.3%; 95% CI, 17.9%-28.7%, respectively). The in-hospital mortality rate was 36% (95% CI, 30.0%-41.9%; 90 deaths; 160 survivors), and surgery was performed in 14.8% (95% CI, 10.4%-19.2%) of patients during the infective endocarditis episode. In-hospital mortality was associated with a higher logistic EuroSCORE (23.1% vs 18.6%; odds ratio [OR], 1.03 per 1% increase; 95% CI, 1.00-1.05), heart failure (59.3% vs 23.7%; OR, 3.36; 95% CI, 1.74-6.45), and acute kidney injury (67.4% vs 31.6%; OR, 2.70; 95% CI, 1.42-5.11). The 2-year mortality rate was 66.7% (95% CI, 59.0%-74.2%; 132 deaths; 115 survivors).nnnCONCLUSIONS AND RELEVANCEnAmong patients undergoing TAVR, younger age, male sex, history of diabetes mellitus, and moderate to severe residual aortic regurgitation were significantly associated with an increased risk of infective endocarditis. Patients who developed endocarditis had high rates of in-hospital mortality and 2-year mortality.

Warfarin and Antiplatelet Therapy Versus Warfarin Alone for Treating Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement

OBJECTIVESnThe study sought to examine the risk of ischemic events and bleeding episodes associated with differing antithrombotic strategies in patients undergoing transcatheter aortic valve replacement (TAVR) with concomitant atrial fibrillation (AF).nnnBACKGROUNDnGuidelines recommend antiplatelet therapy (APT) post-TAVR to reduce the risk of stroke. However, data on the efficacy and safety of this recommendation in the setting of a concomitant indication for oral anticoagulation (due to atrial fibrillation [AF]) with a vitamin K antagonist (VKA) are scarce.nnnMETHODSnA multicenter evaluation comprising 621 patients with AF undergoing TAVR was undertaken. Post-TAVR prescriptions were used to determine the antithrombotic regimen used according to the following 2 groups: monotherapy (MT) with VKA (nxa0= 101) or multiple antithrombotic therapy (MAT) with VKA plus 1 or 2 antiplatelet agents (aspirin or clopidogrel; nxa0= 520). Endpoint definitions were in accordance with Valve Academic Research Consortium-2 criteria. The rate of stroke, major adverse cardiovascular events (stroke, myocardial infarction, or cardiovascular death), major or life-threatening bleeding events, and death were assessed by a Cox multivariate model regression survival analysis according to the antithrombotic regime used.nnnRESULTSnDuring a median follow-up of 13 months (interquartile range: 3 to 31 months) there were no differences between groups in the rate of stroke (MT: 5%, MAT: 5.2%; adjusted hazard ratio [HR]: 1.25; 95% confidence interval [CI]: 0.45 to 3.48; pxa0= 0.67), major adverse cardiovascular events (MT: 13.9%, MAT: 16.3%; adjusted HR: 1.33; 95% CI: 0.75 to 2.36; pxa0=xa00.33), and death (MT 22.8%, MAT: 19.2%; adjusted HR: 0.93; 95% CI: 0.58 to 1.50; pxa0= 0.76). A higher risk of major or life-threatening bleeding was found in the MAT group (MT: 14.9%, MAT: 24.4%; adjusted HR: 1.85; 95% CI: 1.05 to 3.28; pxa0=xa00.04). These results remained similar when patients receiving VKA plus only 1 antiplatelet agent (nxa0= 463) were evaluated.nnnCONCLUSIONSnIn TAVR recipients prescribed VKA therapy for AF, concomitant antiplatelet therapy use appears not toxa0reduce the incidence of stroke, major adverse cardiovascular events, or death, while increasing the risk of major or life-threatening bleeding.

Unidirectional left-to-right interatrial shunting for treatment of patients with heart failure with reduced ejection fraction: a safety and proof-of-principle cohort study.

BACKGROUNDnIn patients with heart failure, interventions to reduce elevated left atrial pressure improve symptoms and reduce the risk of hospital admission. We aimed to assess the safety and potential efficacy of therapeutic left-to-right interatrial shunting in patients with heart failure with reduced ejection fraction.nnnMETHODSnWe did this proof-of-principle cohort study at one centre in Canada. Patients (aged ≥18 years) with New York Heart Association (NYHA) class III chronic heart failure with reduced ejection fraction were enrolled under the Canadian special access programme. Shunt implants were done after transseptal catheterisation with transoesophageal echocardiographic guidance under general anaesthesia. Patients had clinical and echocardiography evaluations at baseline and months 1 and 3 after shunt implantation.nnnFINDINGSnBetween Oct 10, 2013, and March 27, 2015, we enrolled ten patients. The device was successfully implanted in all patients; no device-related or procedural adverse events occurred during follow-up. Transoesophageal echocardiography at 1 month showed that all shunts were patent, with no thrombosis or migration. From baseline to 3 month follow-up, we recorded improvements in NYHA classification (from class III to class II in seven [78%] of nine patients, from class III to class I in one [11%] patient, and no change in one [11%] patient; p=0·0004); quality of life, as assessed by the Duke Activity Status Index (from a mean score of 13 [SD 6·2] to 24·8 [12·9]; p=0·016) and the Kansas City Cardiomyopathy Questionnaire (from a mean score of 44·3 [SD 9·8] to 79·1 [13·0]; p=0·0001); and 6 min walk test distance (from a mean of 244 m [SD 112] to 318 m [134]; p=0·016). Pulmonary capillary wedge pressure was reduced from a mean of 23 mm Hg (SD 5) at baseline to 17 mm Hg (8) at 3 months (p=0·035), with no changes in right atrial pressure, pulmonary arterial pressure, or pulmonary resistance. No patient was admitted to hospital for worsening heart failure. One (10%) patient was admitted to hospital with gastrointestinal bleeding at month 1; one (10%) patient died after incessant ventricular tachycardia storm, which led to terminal heart failure 2 months post-procedure.nnnINTERPRETATIONnThis first-in-man experience with an implanted left-to-right interatrial shunt demonstrates initial safety and early beneficial clinical and haemodynamic outcomes in patients with heart failure with reduced ejection fraction. Further large-scale randomised studies are warranted.nnnFUNDINGnV-Wave.

Initial Experience of Transcatheter Mitral Valve Replacement With a Novel Transcatheter Mitral Valve: Procedural and 6-Month Follow-Up Results

BACKGROUNDnThere are scarce data available on transcatheter mitral valve replacement (TMVR), and these have been limited to procedural results, with no follow-up status reported.nnnOBJECTIVESnThe goal of this study was to evaluate the feasibility, procedural results, and 6-month follow-up outcomes after TMVR with a mitral transcatheter heart valve (Fortis, Edwards Lifesciences, Irvine, California).nnnMETHODSnWe report a series of 3 patients (mean age 71 ± 9 years, 2 men) who had TMVR under a compassionate clinical use program. All patients treated had functional mitral regurgitation (MR) secondary to ischemic cardiomyopathy (prior bypass surgery in all cases; left ventricular ejection fraction between 25% and 30%) and were considered to be at very high surgical risk (mean Society of Thoracic Surgeons score: 9.3).nnnRESULTSnThe procedure was performed through the transapical approach, and the valve was successfully implanted in all cases, with no major complications. At hospital discharge, echocardiographic evaluation revealed trace residual MR in 2 patients and no MR in 1 patient. The mean transvalvular mitral gradient was ≤4 mm Hg in all patients. At the 3-month follow-up, the valve function remained unchanged, and transesophageal echocardiography and computed tomography showed no structural failures. All patients had improvements in functional status, in exercise capacity as evaluated by 6-min walk test, and in quality of life. At 6-month follow-up, all patients remain alive, without hospital readmission for heart failure and with New York Heart Association functional class ≤II.nnnCONCLUSIONSnTMVR with this valve is feasible and is associated with good outcomes. Optimal valve functional results were obtained acutely and were sustained at 6-month follow-up in all patients. Further studies with a larger number of patients and longer follow-up are warranted.

Cardiovascular Magnetic Resonance to Evaluate Aortic Regurgitation After Transcatheter Aortic Valve Replacement.

BACKGROUNDnResidual aortic regurgitation (AR) following transcatheter aortic valve replacement (TAVR) is associated with greater mortality; yet, determining AR severity post-TAVR using Doppler echocardiography remains challenging. Cardiovascular magnetic resonance (CMR) is purported as a more accurate means of quantifying AR; however, no data exist regarding the prognostic value of AR as assessed by CMR post-TAVR.nnnOBJECTIVESnThis study sought to evaluate the effect of AR assessed with CMR on clinical outcomes post-TAVR.nnnMETHODSnWe included 135 patients from 3 centers. AR was quantified using regurgitant fraction (RF) measured by phase-contrast velocity mapping CMR at a median of 40 days post-TAVR, and using Doppler echocardiography at a median of 6 days post-TAVR. Median follow-up was 26 months. Clinical outcomes included mortality and rehospitalization for heart failure.nnnRESULTSnModerate-severe AR occurred in 17.1% and 12.8% of patients as measured by echocardiography and CMR, respectively. Higher RF post-TAVR was associated with increased mortality (hazard ratio: 1.18 for each 5% increase in RF [95% confidence interval: 1.08 to 1.30]; pxa0< 0.001) and the combined endpoint of mortality and rehospitalization for heart failure (hazard ratio: 1.19 for each 5% increase in RF; 95% confidence interval: 1.15 to 1.23; pxa0< 0.001). Prediction models yielded significant incremental predictive value; CMR performed a median of 40 days post-TAVR had a greater association with post-TAVR clinical events compared with early echocardiography (pxa0< 0.01). RFxa0≥30% best predicted poorer clinical outcomes (pxa0< 0.001 for either mortality or the combined endpoint of mortality and heart failure rehospitalization).nnnCONCLUSIONSnWorse CMR-quantified AR was associated with increased mortality and poorer clinical outcomes following TAVR. Quantifying AR with CMR may identify patients with AR who could benefit from additional treatment measures.

Aortic Bioprosthetic Valve Durability: Incidence, Mechanisms, Predictors, and Management of Surgical and Transcatheter Valve Degeneration

In recent times, there has been a considerable increase in the use of aortic bioprostheses (vs. mechanical prostheses) forxa0treating aortic valve disease, and this tendency is likely to continue in the near future. However, the occurrence of structural valve degeneration, limiting valve durability, remains an important drawback of surgical and transcatheter bioprostheses. In this paper, we provide an overview of bioprosthetic valve durability, focusing on the definition, incidence, mechanisms, predictive factors, and management of structural degeneration of aortic bioprostheses.