Prospective validation of a risk score to predict pacemaker implantation after transcatheter aortic valve replacement.

INTRODUCTION: The need for pacemaker is a common complication after transcatheter aortic valve replacement (TAVR). We previously described the Emory Risk Score (ERS) to predict the need for new pacemaker implant (PPM) after TAVR. Metrics included in the score are a history of syncope, pre-existing RBBB, QRS duration ≥140 ms, and prosthesis oversizing ≥16%. To prospectively validate the previously described risk score. METHODS: We prospectively evaluated all patients without pre-existing pacemakers, ICD, or pre-existing indications for pacing undergoing TAVR with the Edwards SAPIEN 3 prosthesis at our institution from March 2019 to December 2020 (n = 661). Patients were scored prospectively; however, results were blinded from clinical decision-making. The primary endpoint was PPM at 30 days after TAVR. Performance of the ERS was evaluated using logistic regression, a calibration curve to prior performance, and receiver operating characteristic (ROC) analysis. RESULTS: A total of 48 patients (7.3%) had PPM after TAVR. A higher ERS predicted an increased likelihood of PPM (OR 2.61, 95% CI: 2.05-3.25 per point, p < 0.001). There was good correlation between observed and expected values on the calibration curve (slope = 1.04, calibration at large = 0.001). The area under the ROC curve was 0.81 (95% CI [0.74-0.88], p < 0.001). CONCLUSIONS: The ERS prospectively predicted the need for PPM in a serial, real-world cohort of patients undergoing TAVR with a balloon-expandable prosthesis, confirming findings previously described in retrospective cohorts. Notably, the prospective performance of the score was comparable with that of the initial cohorts. The risk score could serve as a framework for preprocedural risk stratification for PPM after TAVR.

Safety of same-day discharge after uncomplicated, minimalist transcatheter aortic valve replacement in the COVID-19 era.

OBJECTIVES: We sought to evaluate the safety, efficacy and feasibility of same-day discharge after uncomplicated, minimalist TAVR. BACKGROUND: At the start of the COVID-19 pandemic, we created a same-day discharge (SDD) pathway after conscious sedation, transfemoral (minimalist) TAVR to help minimize risk of viral transmission and conserve hospital resources. Studies support that next-day discharge (NDD) for carefully selected patients following minimalist TAVR is safe and feasible. There is a paucity of data regarding the safety of SDD after TAVR. METHODS: In-hospital and 30 day outcomes of consecutive patients meeting pre-specified criteria for SDD after minimalist TAVR at our institution between March and July of 2020 were reviewed. Outcomes were compared to a NDD cohort from July 2018 through July 2020 that would have met SDD criteria. Primary endpoints were mortality, delayed pacemaker placement, stroke and cardiovascular readmission at 30 days. RESULTS: Twenty nine patients were discharged via the SDD pathway after TAVR. 128 prior NDD patients were identified who met all criteria for SDD. The STS scores were similar between the two groups (SDD 2.6% ±1.5 vs. NDD 2.3% ± 1.2). There were no deaths at 30 days in either group. There was no significant difference in delayed pacemaker placement (SDD 0% vs. NDD 0.8%, p > .99) or cardiovascular readmission (SDD 0% vs. NDD 5.5%, p = .35) at 30 days. CONCLUSIONS: Same day discharge following uncomplicated, minimalist TAVR in selected patients appears to be safe, achieving similar 30 day outcomes as a cohort of next day discharge patients.

Sitagliptin for the prevention and treatment of perioperative hyperglycaemia in patients with type 2 diabetes undergoing cardiac surgery: A randomized controlled trial.

AIM: To assess whether treatment with sitagliptin, starting before surgery and continued during the hospital stay, can prevent and reduce the severity of perioperative hyperglycaemia in patients with type 2 diabetes undergoing coronary artery bypass graft (CABG) surgery. MATERIALS AND METHODS: We conducted a double-blinded, placebo-controlled trial in adults with type 2 diabetes randomly assigned to receive sitagliptin or matching placebo starting 1 day prior to surgery and continued during the hospital stay. The primary outcome was difference in the proportion of patients with postoperative hyperglycaemia (blood glucose [BG] > 10 mmol/L [>180 mg/dL]) in the intensive care unit (ICU). Secondary endpoints included differences in mean daily BG in the ICU and after transition to regular wards, hypoglycaemia, hospital complications, length of stay and need of insulin therapy. RESULTS: We included 182 participants randomized to receive sitagliptin or placebo (91 per group, age 64 ± 9 years, HbA1c 7.6% ± 1.5% and diabetes duration 10 ± 9 years). There were no differences in the number of patients with postoperative BG greater than 10 mmol/L, mean daily BG in the ICU or after transition to regular wards, hypoglycaemia, hospital complications or length of stay. There were no differences in insulin requirements in the ICU; however, sitagliptin therapy was associated with lower mean daily insulin requirements (21.1 ± 18.4 vs. 32.5 ± 26.3 units, P = .007) after transition to a regular ward compared with placebo. CONCLUSION: The administration of sitagliptin prior to surgery and during the hospital stay did not prevent perioperative hyperglycaemia or complications after CABG. Sitagliptin therapy was associated with lower mean daily insulin requirements after transition to regular wards.

Effects and outcomes of cardiac surgery in patients with cardiometabolic syndrome.

INTRODUCTION: Cardiometabolic syndrome (CMS) is diabetes mellitus (or insulin resistance) plus any two of the following risk factors: hypertension, obesity, and hyperlipidemia. The correlation of metabolic syndrome with cardiovascular disease and the increase in the prevalence of patients with risk factors have solidified the importance of continued focus on metabolic syndrome. We retrospectively evaluated single-center data to determine if there is an association between CMS and outcomes. METHODS: The local Society of Thoracic Surgeons Adult Cardiac Database was queried for consecutive coronary bypass (CABG) cases from 2002 to 2010. Short and long-term outcomes were compared between groups of patients with CMS and then risk-adjusted using multiple regression models with adjusted odds ratios and hazard ratios. RESULTS: Of 11 021 CABG cases, 3881 (35.2%) had CMS, with an annual prevalence that increased from 32% to 40% during the study. Patients with CMS were more likely to have prior cerebrovascular diseases, strokes, renal insufficiency, and worse New York Heart Association status. Unadjusted postoperative comparisons revealed that patients with CMS had higher rates of stroke, renal failure, dialysis, deep sternal wound infection, and longer intensive care unit and hospital length of stay. Risk-adjusted odds ratios did not reveal a significant impact on short-term outcomes, however, adjusted hazard ratios continued to demonstrate significant decreases in long-term survival in patients with CMS. CONCLUSIONS: Patients with CMS were more likely to present with increased comorbidities. Patients with CMS undergoing CABG were at risk for worse short-term secondary postoperative outcomes and reduced long-term survival. The data supports the need for further investigation for risk reduction surrounding operative revascularization.

Surgery for Aortic Dilatation in Patients With Bicuspid Aortic Valves: A Statement of Clarification From the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.

Two guidelines from the American College of Cardiology (ACC), the American Heart Association (AHA), and collaborating societies address the risk of aortic dissection in patients with bicuspid aortic valves and severe aortic enlargement: the "2010 ACCF/AHA/AATS/ACR/ASA/SCA/SCAI/SIR/STS/SVM Guidelines for the Diagnosis and Management of Patients With Thoracic Aortic Disease" (Circulation. 2010;121:e266-e369) and the "2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease" (Circulation. 2014;129:e521-e643). However, the 2 guidelines differ with regard to the recommended threshold of aortic root or ascending aortic dilatation that would justify surgical intervention in patients with bicuspid aortic valves. The ACC and AHA therefore convened a subcommittee representing members of the 2 guideline writing committees to review the evidence, reach consensus, and draft a statement of clarification for both guidelines. This statement of clarification uses the ACC/AHA revised structure for delineating the Class of Recommendation and Level of Evidence to provide recommendations that replace those contained in Section 9.2.2.1 of the thoracic aortic disease guideline and Section 5.1.3 of the valvular heart disease guideline.

End-stage renal disease and severe aortic stenosis: Does valve replacement improve one-year outcomes?

BACKGROUND: Treatment for patients with end-stage renal disease (ESRD) and severe aortic stenosis (AS) includes balloon aortic valvuloplasty (BAV), surgical (SAVR), or transcatheter (TAVR) aortic valve replacement. We compared outcomes among these strategies. METHODS: A retrospective review of patients with ESRD undergoing treatment for severe AS between 07/2007 and 06/2015 was performed at our center. Patients were classified based on treatment: BAV-only, TAVR, or SAVR. Baseline characteristics and 30-day outcomes were compared among groups. A 1-year survival analysis was performed. RESULTS: Of 85 patients, 25 (29.4%) underwent BAV, 30 (35.3%) TAVR, and 30 (35.3%) SAVR. Patients in the SAVR group, compared to the BAV or TAVR patients, were younger (63 vs. 74 vs. 71 years, P = 0.02) and had less prior stroke (3.3% vs. 12.0% vs. 30.0%, P = 0.008). While all BAV patients had NYHA class III/IV, 93.3% and 76.7% of patients had NYHA class III/IV in the TAVR and SAVR group, respectively (P = 0.001). BAV patients were less likely to have atrial fibrillation than TAVR or SAVR patients (16.0% vs. 43.3% vs. 50.0%, P = 0.03). All patients were high risk, but there was a statistical trend to lower STS scores in the SAVR group (8.6% vs. 13.5% vs. 13.5%, P = 0.08). There was no significant difference in 30-day mortality (16.7% vs. 10.0% vs. 10.0%, P = 0.74), but BAV treated patients had an increased 1-year mortality compared to those treated with TAVR or SAVR (87.0% vs. 32.0%, vs. 36.7%, P=<0.001). Independent predictors of 1-year mortality were a higher STS score (HR 1.026, 95%CI 1.002-1.051) and BAV-only strategy (BAV vs. TAVR: HR 3.961, 95%CI 1.595-9.840), but dialysis duration and type, and SAVR versus TAVR were not. CONCLUSIONS: Patients with ESRD and severe AS have a similar and higher survival with TAVR or SAVR when compared to BAV at 1-year. These results may influence patient care decisions favoring valve replacement in AS patients with ESRD. © 2016 Wiley Periodicals, Inc.

Anatomical risk models for paravalvular leak and landing zone complications for balloon-expandable transcatheter aortic valve replacement.

BACKGROUND: Though several anatomical characteristics have been reported separately as risk factors for paravalvular leak (PVL) and landing zone (LZ) complications after transcatheter aortic valve replacement (TAVR), multivariate risk models are needed. METHODS: Patients that underwent balloon-expandable TAVR with multidetector cardiac computed tomography (MDCT) sizing were studied. MDCT images were analyzed and the association between anatomical factors and ≥mild PVL, ≥moderate PVL, and LZ complications (annular rupture, requirement of new permanent pacemaker, and coronary obstruction) was determined, and subsequently competing predictive models were developed and validated. RESULTS: A total of 316 consecutive TAVR patients were included. Median age was 82.0 years (74.0-87.0) and STS score was 8.3% (5.4-10.9). Factors associated with ≥mild PVL included TAVR with Sapien/Sapien XT vs. Sapien 3 (OR = 2.50, 95% CI = 1.24-5.07), LVOT nontubularity (OR = 1.02, 95% CI = 1.01-1.04), LZ calcification (OR = 1.01, 95% CI = 1.00-1.01), and low cover index (OR = 0.94, 95% CI = 0.91-0.96). Factors associated with LZ complications included LZ calcification (OR = 1.01, 95% CI 1.00-1.01), leaflet asymmetry (OR = 1.01, 95% CI 1.01-1.02), and cover index (OR = 1.09, 95% CI 1.03-1.14). Predictive models for ≥mild PVL (AUC = 0.71, 95% CI = 0.66-0.77), ≥moderate PVL (AUC = 0.75, 95% CI = 0.65-0.84), and LZ complications (AUC = 0.77, 95% CI = 0.67-0.87) were created using procedural details and anatomical data from the MDCT. Clinical variables were not included as they were poorly correlated with the occurrence of PVL and LZ complications. For each outcome, the area under the curve (AUC) of the multivariate model was superior to the model consisting only of individual factors. CONCLUSIONS: A model using procedural/anatomical characteristics derived from MDCT predicts ≥mild PVL, ≥moderate PVL, and LZ complications post-TAVR. Incorporation of anatomical risks into clinical practice may help stratify patients before TAVR. © 2017 Wiley Periodicals, Inc.

Does minimalist transfemoral transcatheter aortic valve replacement produce better survival in patients with severe chronic obstructive pulmonary disease?

OBJECTIVES: To compare outcomes after minimalist and standard transfemoral transcatheter aortic valve replacement (TF-TAVR) in patients with severe chronic obstructive pulmonary disease (COPD). BACKGROUND: TF-TAVR is increasingly performed with conscious sedation and transthoracic echocardiography guidance (minimalist). The safety/efficacy of this technique in patients with severe COPD is unknown. METHODS: We compared demographics, 30-day outcomes and 1-year survival of patients with severe COPD (FEV1% ≤50) who underwent minimalist vs. standard TF-TAVR between 2008 and 2015 at our institution. RESULTS: Of 88 patients with severe COPD, 46 underwent minimalist and 42 underwent standard TF-TAVR. There were no differences on baseline characteristics, except for more history of coronary artery bypass grafting (45.5% vs. 20.6%, P = 0.03) and less history of cerebrovascular disease (16.7% vs. 45.5%, P = 0.03) in the standard TF-TAVR. Seventeen minimalist TF-TAVR patients (41.0%) were transferred directly to the general medical ward with telemetry monitoring (without ICU stay); all standard TF-TAVR patients went to the ICU. Minimalist TF-TAVR patients had shorter procedure time (97 vs. 129 min, P < 0.001), ICU time (21.8 vs. 29.8 hr, P = 0.001) and length of stay (2 vs. 5 days, P = 0.001). There were no differences in procedure complications and 30-day mortality between groups. In our multivariate analysis, minimalist TF-TAVR (HR 0.28, 95%CI 0.08-0.97) and previous coronary revascularization (HR 0.24, 95%CI 0.09-0.65) were associated with increased 1-year survival. In contrast, moderate paravalvular leak (HR 7.73, 95%CI 1.94-30.84) was associated with decreased 1-year survival. CONCLUSION: In patients with severe COPD, Minimalist TF-TAVR results in less resource utilization and improved 1-year survival compared to standard approach. Our findings should be validated in a larger cohort of patients with severe COPD. © 2016 Wiley Periodicals, Inc.

Postsurgical hemodynamics of the aortic valve bypass operation evaluated with phase contrast magnetic resonance.

PURPOSE: To characterize the postsurgical hemodynamics in aortic valve bypass (AVB) patients, and to determine the relationship between presurgical native aortic valve pressure gradient and postsurgical hemodynamics. MATERIALS AND METHODS: Twenty patients scheduled for AVB surgery underwent presurgical transthoracic Doppler echocardiography to assess the degree of aortic stenosis and postsurgical cardiac magnetic resonance imaging (MRI) to acquire phase contrast magnetic resonance (PCMR) flow values along the ascending and descending aorta, and in the conduit. Net flow values were calculated from the PCMR images and compared to presurgical aortic valve pressure gradient measurements. RESULTS: PCMR showed that: 1) The blood flow split between the aorta and the conduit was 35%:65% of cardiac output and 2) 60% of patients had net retrograde blood flow in the superior thoracic aorta over the cardiac cycle. Patients with presurgical pressure gradient (ΔP) > 45 mmHg had significantly less blood flow out of the native aorta than patients with ΔP < 45 mmHg, and had significantly more retrograde flow in the superior thoracic aorta postsurgery. CONCLUSION: In patients undergoing AVB, presurgical aortic valve pressure gradient is associated with the volume of blood flow out the aorta and the direction of blood flow in the superior thoracic aorta after conduit addition as measured by PCMR.

Transfusion and hematologic variables after fibrinogen or platelet transfusion in valve replacement surgery: preliminary data of purified lyophilized human fibrinogen concentrate versus conventional transfusion.

BACKGROUND: Platelet (PLT) and plasma transfusion remain the mainstay hemostatic therapy for perioperative bleeding. Several studies have indicated that acquired fibrinogen (FIB) deficiency can be the primary cause of bleeding after cardiac surgery. The aim of this study was to compare hematologic and transfusion profiles between the first-line FIB replacement and PLT transfusion in post-cardiac surgical bleeding. STUDY DESIGN AND METHODS: In this prospective, randomized, open-label study, 20 adult patients who underwent valve replacement or repair and fulfilled preset visual bleeding scale were randomized to 4 g of FIB or 1 unit of apheresis PLTs. Primary endpoints included hemostatic condition in the surgical field and 24-hour hemostatic product usage. Hematologic data, clinical outcome, and safety data were collected up to the 28th day postoperative visit. RESULTS: In patients who received the first-line FIB concentrate (n = 10), the visual bleeding scale improved after intervention, and the incidence of PLT transfusion and total plasma donor exposure were lower compared to the PLT group (n = 10). Postintervention FIB level was statistically higher (209 mg/dL vs. 165 mg/dL) in the FIB group than in the PLT group, but PLT count and prothrombin were lower. There were no statistical differences in the postoperative blood loss and red blood cell transfusion between two groups. CONCLUSIONS: Our preliminary data indicate that the primary FIB replacement may potentially reduce the incidence of PLT transfusion and the number of donor exposures. Plasma FIB level of 200 mg/dL is attainable with a single dose of 4 g, and this level seems to mitigate bleeding despite moderately decreased thrombin generation.

Long-term survival for patients with metabolic syndrome after bioprosthetic or mechanical valve replacement.

BACKGROUND: Metabolic diseases are thought to negatively impact the long-term survival of cardiac patients and have been shown to be associated with reduced durability of bioprosthetic heart valves. The purpose of this study is to determine whether long-term survival of post-valve replacement patients is affected by the presence of metabolic disease, and whether choice of tissue versus mechanical prosthesis impacts survival. METHODS: A retrospective review was conducted of all isolated valve replacements performed between 2002 and 2011 from the STS adult cardiac database of Emory Healthcare Hospitals. A total of 1,222 cases were reviewed, of which 909 patients had AVR (661 tissue, 248 mechanical), and 313 MVR (190 tissue, 123 mechanical). Cardiometabolic syndrome (CMS), in accordance with the World Health Organization (WHO) definition, was present in 242 of 1,222 (19.8%) cases in entire cohort, 203 of 909 (22.3%) in AVR, and 39 of 313 (12.5%) in MVR. Cox proportional hazard regression analysis was used to calculate long-term survival after adjusting for propensity score (PS), Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM), and direct covariates for valve and implant type and stratifying by CMS. RESULTS: In PS adjusted AVR, patients with CMS risk factors had worse survival compared to metabolic risk-free patients (AHR = 3.47), as was the case for MVR (AHR = 4.06). Tissue MVR patients with CMS had higher hazard of death compared to patients with no diabetes and no metabolic risk factors after adjusting for PROM (AHR = 3.33) and direct covariates (AHR = 3.91). CONCLUSIONS: Metabolic diseases negatively impact long-term survival of aortic and mitral valve replacement (MVR) patients. Tissue prostheses are associated with worse long-term survival following MVR.

Mitral regurgitation increases systolic strains in remote zone and worsens left ventricular dyssynchrony in a swine model of ischemic cardiomyopathy.

Background: Ischemic mitral regurgitation (IMR) imposes volume overload on the left ventricle (LV), accelerating adverse LV remodeling. In this study, we sought to investigate the impact of volume overload due to IMR on regional myocardial contractile mechanics. Methods: Ten Yorkshire swine were induced with myocardial infarction (MI) by occluding the left circumflex coronary artery (LCx). Cardiac MRI was performed at baseline (BL) and 2.5 months (2.5M) post-MI. IMR was quantified with epicardial echocardiography 3 months post-MI. The animals were then assigned to 2 groups: no/mild MR (nmMR, n = 4) and moderate/severe MR (msMR, n = 6). MRI images were analyzed to assess infarction size, end-diastolic and end-systolic volume (EDV and ESV, respectively), ejection fraction (EF), longitudinal strain (LS), circumferential strain (CS), and systolic dyssynchrony index (SDI). The myocardial region was divided into infarction, border, and remote zones based on the LCx-supplied region. Results: There was no difference in the infarction size. Group-wise comparison of LS and CS between BL and 2.5M demonstrated that LS and CS in the infarction zone and the border zone decreased at 2.5M in both groups. However, LS and CS in the remote zone were elevated only in the msMR group (LS: -9.81 ± 3.96 vs. -12.58 ± 5.07, p < 0.01; CS; -12.78 ± 3.81 vs. -16.09 ± 3.33, p < 0.01) at 2.5M compared to BL. The SDI of CS was significantly elevated in the msMR group (0.1255 vs. 0.0974, p = 0.015) at 2.5M compared to BL. Conclusions: Elevated LS and CS in the remote zone were observed in moderate/severe MR and ventricular dyssynchrony. These elevated cardiac strains, coupled with ventricular dyssynchrony, may contribute to the progression of MR, thereby accelerating heart failure.

Transcatheter Myotomy to Reduce Left Ventricular Outflow Obstruction.

BACKGROUND: Left ventricular outflow tract (LVOT) obstruction is a source of morbidity in hypertrophic cardiomyopathy (HCM) and a life-threatening complication of transcatheter mitral valve replacement (TMVR) and transcatheter aortic valve replacement (TAVR). Available surgical and transcatheter approaches are limited by high surgical risk, unsuitable septal perforators, and heart block requiring permanent pacemakers. OBJECTIVES: The authors report the initial experience of a novel transcatheter electrosurgical procedure developed to mimic surgical myotomy. METHODS: We used septal scoring along midline endocardium (SESAME) to treat patients, on a compassionate basis, with symptomatic LVOT obstruction or to create space to facilitate TMVR or TAVR. RESULTS: In this single-center retrospective study between 2021 and 2023, 76 patients underwent SESAME. In total, 11 (14%) had classic HCM, and the remainder underwent SESAME to facilitate TMVR or TAVR. All had technically successful SESAME myocardial laceration. Measures to predict post-TMVR LVOT significantly improved (neo-LVOT 42 mm2 [Q1-Q3: 7-117 mm2] to 170 mm2 [Q1-Q3: 95-265 mm2]; P < 0.001; skirt-neo-LVOT 169 mm2 [Q1-Q3: 153-193 mm2] to 214 mm2 [Q1-Q3: 180-262 mm2]; P < 0.001). Among patients with HCM, SESAME significantly decreased invasive LVOT gradients (resting: 54 mm Hg [Q1-Q3: 40-70 mm Hg] to 29 mm Hg [Q1-Q3: 12-36 mm Hg]; P = 0.023; provoked 146 mm Hg [Q1-Q3: 100-180 mm Hg] to 85 mm Hg [Q1-Q3: 40-120 mm Hg]; P = 0.076). A total of 74 (97.4%) survived the procedure. Five experienced 3 of 76 (3.9%) iatrogenic ventricular septal defects that did not require repair and 3 of 76 (3.9%) ventricular free wall perforations. Neither occurred in patients treated for HCM. Permanent pacemakers were required in 4 of 76 (5.3%), including 2 after concomitant TAVR. Lacerations were stable and did not propagate after SESAME (remaining septum: 5.9 ± 3.3 mm to 6.1 ± 3.2 mm; P = 0.8). CONCLUSIONS: With further experience, SESAME may benefit patients requiring septal reduction therapy for obstructive hypertrophic cardiomyopathy as well as those with LVOT obstruction after heart valve replacement, and/or can help facilitate transcatheter valve implantation.

Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.

BACKGROUND: Many patients with severe aortic stenosis and coexisting conditions are not candidates for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve implantation (TAVI) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis. METHODS: We randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve. The primary end point was the rate of death from any cause. RESULTS: A total of 358 patients with aortic stenosis who were not considered to be suitable candidates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan­Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P<0.001). The rate of the composite end point of death from any cause or repeat hospitalization was 42.5% with TAVI as compared with 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35 to 0.59; P<0.001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among patients who had undergone TAVI than among those who had received standard therapy (25.2% vs. 58.0%, P<0.001). At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs. 1.1%, P=0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001). In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram. CONCLUSIONS: In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).

Carotid artery access for transcatheter aortic valve replacement.

We report three patients who had successful transcatheter aortic valve replacement (TAVR) via carotid artery access. None were candidates for thoracotomy (including minimal access incisions) and had no other vascular access sites that would accommodate the transcatheter valve sheath. Antegrade carotid perfusion and retrograde insertion of the delivery sheath maintained cerebral blood flow without sequelae. Carotid access for TAVR is an option for unusual patients without other access.

Postoperative warfarin following mitral valve repair or bioprosthetic valve replacement.

BACKGROUND AND AIM OF THE STUDY: Short-term postoperative warfarin therapy has been used to decrease neurologic events following mitral valve repair or bioprosthetic replacement (MVR). The study aim was to compare the short- and long-term outcomes of patients undergoing mitral valve surgery with or without short-term postoperative warfarin. METHODS: A single academic US institution retrospective review was performed on discharged patients who underwent MVR between January 1996 and March 2010. Patients were allocated to two groups: MVR with four to six weeks of postoperative warfarin (n = 315; Warfarin group) or MVR without postoperative warfarin (n = 257; No warfarin group). Patients who required either preoperative or postoperative warfarin for any disease process (e.g., atrial fibrillation, mechanical valve, deep venous thrombosis) were excluded. Logistic and Cox proportional hazards regression models were constructed to evaluate the effects of warfarin on short- and long-term outcomes, respectively. Adjusted odds ratios (AOR) and adjusted hazard ratios (AHR), with 95% confidence intervals (CI) were constructed for each outcome. To reduce selection bias, propensity scoring methods were employed to balance the groups with respect to 54 preoperative variables. RESULTS: Mean age was not significantly different between groups (No warfarin group = 56.8 +/- 14.5 years versus Warfarin group 55.9 +/- 12.9 years; p = 0.46). The average length of hospital stay was 9.8 +/- 8.4 days and 7.3 +/- 4.5 days in the No warfarin and Warfarin groups, respectively (p < 0.001). At the six-week follow up the incidences of stroke (p = 0.74), pleural effusions (p = 0.88), pericardial effusions (p = 0.75), and bleeding complications (p = 0.30) were similar between the two groups. In an unadjusted Kaplan-Meier analysis, the No warfarin group had a poorer long-term survival than the Warfarin group (p < 0.001). However, after propensity adjustment, the benefit of warfarin was not statistically significant (AHR = 0.66, 95% CI 0.40-1.08, p = 0.098). CONCLUSION: The use of postoperative warfarin following MVR does not reduce the incidence of stroke at early follow up. However, there remains a trend for improved long-term outcomes in those patients receiving postoperative warfarin therapy.

Trends in surgical aortic valve replacement in pre- and post-transcatheter aortic valve replacement eras at a structural heart center.

Background: The advent of transcatheter aortic valve replacement (TAVR) has directly impacted the lifelong management of patients with aortic valve disease. The U.S. Food and Drug Administration has approved TAVR for all surgical risk: prohibitive (2011), high (2012), intermediate (2016), and low (2019). Since then, TAVR volumes are increasing and surgical aortic valve replacements (SAVR) are decreasing. This study sought to evaluate trends in isolated SAVR in the pre- and post-TAVR eras. Methods: From January 2000 to June 2020, 3,861 isolated SAVRs were performed at a single academic quaternary care institution which participated in the early trials of TAVR beginning in 2007. A formal structural heart center was established in 2012 when TAVR became commercially available. Patients were divided into the pre-TAVR era (2000-2011, n = 2,426) and post-TAVR era (2012-2020, n = 1,435). Data from the institutional Society of Thoracic Surgeons National Database was analyzed. Results: The median age was 66 years, similar between groups. The post-TAVR group had a statistically higher rate of diabetes, hypertension, dyslipidemia, heart failure, more reoperative SAVR, and lower STS Predicted Risk of Mortality (PROM) (2.0% vs. 2.5%, p < 0.0001). There were more urgent/emergent/salvage SAVRs (38% vs. 24%) and fewer elective SAVRs (63% vs. 76%), (p < 0.0001) in the post-TAVR group. More bioprosthetic valves were implanted in the post-TAVR group (85% vs. 74%, p < 0.0001). Larger aortic valves were implanted (25 vs. 23 mm, p < 0.0001) and more annular enlargements were performed (5.9% vs. 1.6%, p < 0.0001) in the post-TAVR era. Postoperatively, the post-TAVR group had less blood product transfusion (49% vs. 58%, p < 0.0001), renal failure (1.4% vs. 4.3%, p < 0.0001), pneumonia (2.3% vs. 3.8%, p = 0.01), shorter lengths of stay, and lower in-hospital mortality (1.5% vs. 3.3%, p = 0.0007). Conclusion: The approval of TAVR changed the landscape of aortic valve disease management. At a quaternary academic cardiac surgery center with a well-established structural heart program, patients undergoing isolated SAVR in the post-TAVR era had lower STS PROM, more implantation of bioprosthetic valves, utilization of larger valves, annular enlargement, and lower in-hospital mortality. Isolated SAVR continues to be performed in the TAVR era with excellent outcomes. SAVR remains an essential tool in the lifetime management of aortic valve disease.

Hybrid Closure of Postinfarction Apical Ventricular Septal Defect Using Septal Occluder Device and Right Ventricular Free Wall: The Apical BASSINET Concept.

BACKGROUND: Postinfarction ventricular septal defect (VSD) is a catastrophic complication of myocardial infarction. Surgical repair still has poor outcomes. This report describes clinical outcomes after a novel hybrid transcatheter/surgical repair in patients with apical VSD. METHODS: Seven patients with postmyocardial infarction apical VSD underwent hybrid transcatheter repair via subxiphoid surgical access. A transcatheter occluder (Amplatzer Septal Occluder) with a trailing premounted suture was deployed through the right ventricular wall and through the ventricular septum into the left ventricular apex. The trailing suture was used to connect an anchor external to the right ventricular wall. Tension on the suture then collapses the right ventricular free wall against the septum and left ventricular occluder, thereby obliterating the VSD. Outcomes were compared with 9 patients who underwent surgical repair using either patch or primary suture closure. RESULTS: All patients had significant left-to-right shunt (Qp:Qs 2.5:1; interquartile range [IQR, 2.1-2.6] hybrid repair versus 2.0:1 [IQR, 2.0-2.5] surgical repair), and elevated right ventricular systolic pressure (62 [IQR, 46-71] versus 49 [IQR, 43-54] mm Hg, respectively). All had severely depressed stroke volume index (22 versus 21 mL/m2) with ≈45% in each group requiring mechanical support preprocedurally. The procedure was done 15 (IQR, 10-50) versus 24 (IQR, 10-134) days postmyocardial infarction, respectively. Both groups of patients underwent repair with technical success and without intraprocedural death. One patient in the hybrid group and 4 in the surgical group developed multiorgan failure. The hybrid group had a higher survival at discharge (86% versus 56%) and at 30 days (71% versus 56%), but similar at 1 year (57% versus 56%). During follow-up, 1 patient in each group required reintervention for residual VSD (hybrid: 9 months versus surgical: 5 days). CONCLUSIONS: Early intervention with a hybrid transcatheter/surgical repair may be a viable alternative to traditional surgery for postinfarction apical VSD.