Impact of concomitant surgical interventions on outcomes of septal myectomy in obstructive hypertrophic cardiomyopathy.

BACKGROUND: Septal myectomy (SM) is offered to symptomatic patients with obstructive hypertrophic cardiomyopathy (oHCM) despite medical therapy. Frequently, patients undergo concomitant planned or ad-hoc mitral valve replacement (MVR), aortic valve replacement (SAVR), or coronary artery bypass grafting (CABG). OBJECTIVES: We sought to assess characteristics and outcomes of patients with oHCM undergoing concomitant surgical interventions at the time of SM. METHODS: The National Readmission Databases were used to identify all SM admissions in the United States (2010-2019). Patients undergoing SM were stratified into: isolated SM (±MV repair), SM + CABG only, SM + MVR, SM + SAVR, and SM + MVR + SAVR. Primary outcomes were in-hospital mortality, in-hospital adverse events, and 30-day readmission. RESULTS: 12,063 encounters of patients who underwent SM were included (56.1% isolated SM, 9.0% SM + CABG only, 17.5% SM + MVR, 13.1% SM + SAVR, and 4.3% SM + MVR + SAVR). Patients who underwent isolated SM were younger (54.3 vs. 67.1 years-old, p < 0.01) and had lower overall comorbidity burden. In-hospital mortality was lowest in isolated SM, followed by CABG only, SM + SAVR, SM + MVR, and SM + SAVR+MVR groups (2.3% vs. 3.7% vs. 5.3% vs. 6.7% vs. 13.7%, p < 0.01), respectively. SM with combined surgical interventions was associated with higher adverse in-hospital events (24.3% vs. 11.1%, p < 0.01) and 30-day readmissions (16.9% vs. 10.4%, p < 0.01). MV repair performed concomitantly with SM was not associated with increased in-hospital mortality (3.9% vs. 3.4%, p = 0.72; aOR 0.99; 95% CI: 0.54-1.80, p = 0.97]) or adverse clinical events. CONCLUSIONS: In SM for oHCM, patients undergoing concomitant surgical interventions were characteristically distinct. Aside from MV repair, concomitant interventions were associated with worse in-hospital death, adverse in-hospital events, and 30-day readmission.

Mitral Valve Transcatheter Edge-to-Edge Repair Volumes and Trends.

Background: Despite an association between operator volumes and procedural success, there remains an incomplete understanding of the contemporary utilization and procedural volumes for mitral valve transcatheter edge-to-edge repair (MTEER). We aimed to identify annual operator procedural volumes, temporal trends, and geographic variability for MTEER among Medicare patients in the United States (US). Methods: We queried the National Medicare Provider Utilization and Payment Database for a CPT code (33418) specific for MitraClip device from 2015 through 2019. We analyzed annual operator procedural volumes and incidence and identified longitudinal and geographic trends in MTEER utilization. Results: From 2015 through 2019, a total of 27,034 MTEER procedures were performed among Medicare patients in the US. The nationwide incidence increased from 6.2 per 100,000 patients in 2015 to 23.8 per 100,000 patients in 2019, a 283% increase over the study period (Ptrend < 0.001). The incidence of MTEER by state varied by nearly 900% (range 5.5 to 54.9 per 100,000 person-years). In 2019, the mean annual MTEER operator annual volume was 9.1 MTEER procedures and had grown from 6.2 per year in 2015. Conclusions: In this nationwide study of Medicare beneficiaries in the United States, we identified a significant and sustained increase in the utilization of MTEER devices and operators and growth in annual procedural volumes from 2015 through 2019 with considerable variability in utilization by state. Further studies are needed to understand the clinical impact of variability in utilization and the optimal procedural volumes to ensure high efficacy outcomes and maintain critical access to MTEER therapies.

1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results.

BACKGROUND: High surgical risk may preclude mitral valve replacement in many patients. Transcatheter mitral valve replacement (TMVR) using transfemoral transseptal access is a novel technology for the treatment of mitral regurgitation (MR) in high-risk surgical patients. OBJECTIVES: This analysis evaluates 30-day and 1-year outcomes of the Intrepid TMVR Early Feasibility Study in patients with ≥moderate-severe MR. METHODS: The Intrepid TMVR Early Feasibility Study is a multicenter, prospective, single-arm study. Clinical events were adjudicated by a clinical events committee; endpoints were defined according to Mitral Valve Academic Research Consortium criteria. RESULTS: A total of 33 patients, enrolled at 9 U.S. sites between February 2020 and August 2022, were included. The median age was 80 years, 63.6% of patients were men, and mean Society of Thoracic Surgeons Predicted Risk of Mortality for mitral valve replacement was 5.3%. Thirty-one (93.9%) patients were successfully implanted. Median postprocedural hospitalization length of stay was 5 days, and 87.9% of patients were discharged to home. At 30 days, there were no deaths or strokes, 8 (24.2%) patients had major vascular complications and none required surgical intervention, there were 4 cases of venous thromboembolism all successfully treated without sequelae, and 1 patient had mitral valve reintervention for severe left ventricular outflow tract obstruction. At 1 year, the Kaplan-Meier all-cause mortality rate was 6.7%, echocardiography showed ≤mild valvular MR, there was no/trace paravalvular leak in all patients, median mitral valve mean gradient was 4.6 mm Hg (Q1-Q3: 3.9-5.3 mm Hg), and 91.7% of survivors were in NYHA functional class I/II with a median 11.4-point improvement in Kansas City Cardiomyopathy Questionnaire overall summary scores. CONCLUSIONS: The early benefits of the Intrepid transfemoral transseptal TMVR system were maintained up to 1 year with low mortality, low reintervention, and near complete elimination of MR, demonstrating a favorable safety profile and durable valve function.

Intermediate-Term Outcomes Following Transcatheter Aortic Valve Implantation in Patients with a History of Chest Radiation Therapy: A Propensity Score Matched Analysis.

Chest radiation therapy (XRT) has been associated with a higher rate of mortality following surgical aortic valve replacement. We performed a single-center retrospective analysis of patients with severe AS who underwent TAVI from January 1 2012 to July 31 2020 comparing patients with and without XRT. A total of 915 patients met inclusion criteria, with a total of 50 patients found to have a history of XRT. At a mean follow-up of 2.4 years, unadjusted and propensity score matching analysis demonstrated no differences in mortality, heart failure or bleeding-related hospitalization, overall stroke, and 30-day pacemaker implantation in patients with and without XRT.

Clinical Predictors of Mortality and Heart Failure Hospitalization in Patients With Severe Tricuspid Regurgitation.

Background: There is an incomplete understanding of the predictors of morbidity and mortality in patients with severe tricuspid regurgitation (TR). This study sought to identify key risk factors for all-cause mortality and heart failure (HF) hospitalization among patients with severe TR. Methods: Patients with severe TR were identified from 2 centers, Oregon Health & Science University and Abrazo Health, from January 01, 2016 to December 31, 2018. Patients with any concomitant severe valvular diseases or prior valvular intervention were excluded. Multivariable regression was utilized to identify demographic, clinical, and echocardiographic variables independently associated with all-cause mortality or HF hospitalization. Results: 435 patients with severe TR were followed for a median of 2.8 years. The mean age of the population was 66.9 ± 18.5 years and 58% were female. All-cause mortality was identified in 20.5% of the population. Of the cohort, 35.4% of patients were hospitalized for HF. Isolated tricuspid valve intervention was performed in 2.5% of patients. Independent predictors of all-cause mortality included history of solid tumor (odds ratio [OR] 6.6, 95% confidence interval [CI] 2.1-19.1, p = 0.001), history of peripheral artery disease (OR 3.5, 95% CI 1.2-9.4, p = 0.013), and elevated international normalized ratio in the absence of anticoagulation (OR 1.9, 95% CI 1.2-3.2, p = 0.008). Predictors of HF hospitalization included history of diabetes mellitus (OR 2.2, 95% CI 1.1-4.0, p = 0.014) and history of reduced left ventricular ejection fraction (OR 5.7, 95% CI 2.9-11.7, p < 0.0001). Conclusions: Severe untreated TR is associated with high mortality and frequent HF hospitalizations. Understanding predictors of these outcomes is important to identify patients who may benefit from early tricuspid valve intervention to help improve outcomes in this patient population.

Hospital Procedural Volume and Clinical Outcomes Following Septal Reduction Therapy in Obstructive Hypertrophic Cardiomyopathy.

Background Prior national data showed a substantial in-hospital mortality in septal myectomy (SM) with an inverse volume-outcomes relationship. This study sought to assess the contemporary outcomes of septal reduction therapy and volume-outcome relationship in obstructive hypertrophic cardiomyopathy. Methods and Results All septal reduction therapy admissions between 2010 to 2019 in the United States were analyzed using the National Readmission Databases. Hospitals were stratified into tertiles of low-, medium-, and high-volume based on annualized procedural volume of alcohol septal ablation and SM. Of 19 007 patients with obstructive hypertrophic cardiomyopathy who underwent septal reduction therapy, 12 065 (63%) had SM. Two-thirds of hospitals performed ≤5 SM or alcohol septal ablation annually. In all SM encounters, 482 patients (4.0%) died in-hospital post-SM. In-hospital mortality was <1% in 1505 (88.4%) hospitals, 1% to 10% in 30 (1.8%) hospitals, and ≥10% in 167 (9.8%) hospitals. There were 63 (3.7%) hospitals (averaging 2.2 SM cases/year) with 100% in-hospital mortality. Post-SM (in low-, medium-, and high-volume centers, respectively), in-hospital mortality (5.7% versus 3.9% versus 2.4%, P=0.003; adjusted odds ratio [aOR], 2.86 [95% CI, 1.70-4.80], P=0.001), adverse in-hospital events (21.30% versus 18.0% versus 12.6%, P=0.001; aOR, 1.88 [95% CI, 1.45-2.43], P=0.001), and 30-day readmission (17.1% versus 12.9% versus 9.7%, P=0.001; adjusted hazard ratio, 1.53 [95% CI, 1.27-1.96], P=0.001) were significantly higher in low- versus high-volume hospitals. For alcohol septal ablation, the incidence of in-hospital death and all other outcomes did not differ by hospital volume. Conclusions In-hospital SM mortality was 4% with an inverse volume-mortality relationship. Mortality post-alcohol septal ablation was similar across all volume tertiles. Morbidity associated with SM was substantial across all volume tertiles.

Severe MR With Prior Alfieri Stitch Treated With Transcatheter Edge-to-Edge Repair and a Vascular Plug.

We present a case of a high-risk surgical patient with prior surgical Alfieri stitch and recurrent severe mitral regurgitation. In cases with suitable anatomy, mitral valve transcatheter edge-to-edge repair and vascular plug closure of a small regurgitant orifice can be used with excellent results. (Level of Difficulty: Advanced.).

Haemolysis resolution after transcatheter valve in valve within a prior mitral annuloplasty ring: a case report.

Background: Transcatheter mitral valve in ring procedure has emerged as a minimally invasive alternative to re-do surgery among patients with failed mitral annuloplasty rings. Uncommonly, haemolysis presents as a complication after the percutaneous valvular procedures and often require aggressive measures to correct paravalvular leaks and mechanical collision. Case summary: We report a case of an 82-year-old female who underwent a transcatheter valve in ring procedure (Edwards Sapien S3, Edwards Lifesciences) for symptomatic severe mitral regurgitation from a bioprosthetic annuloplasty ring failure complicated by acute haemolytic anaemia a week after the procedure manifesting as dark coloured urine, profound icterus, and acute renal injury. She was treated with a post-dilation balloon valvuloplasty leading to reduction in haemolysis, but the patient was readmitted with acute haemolysis episode again. At this time, a decision was made to perform a repeat valve in valve TMVR with a 29 mm S3 Edwards Sapien valve which led to a resolution of haemolysis. Discussion: In this case, the leaflets of previously placed S3 valve sealed the blood flow through the valve frame thus diverting the blood flow away from the area of collision leading to resolution of haemolysis.

Clinical Outcomes of Revascularization with Percutaneous Coronary Intervention Prior to Transcatheter Aortic Valve Replacement: A Comprehensive Meta-Analysis.

BACKGROUND: Prior studies on revascularization prior to transcatheter aortic valve replacement (TAVR), in patients with significant coronary artery disease (CAD), have reported mixed results. AIM: We sought to perform a meta-analysis combining current evidence by investigating outcomes of revascularization in patients who undergo TAVR with coexisting CAD. METHODS: We searched literature for studies reporting on outcomes following TAVR performed with versus without pre-TAVR PCI, for coexisting CAD. Random-effect model was used to pool estimates of odds ratios (ORs). RESULTS: Twenty-four reports with 12,182 TAVR patients were included: 22 observational and 2 clinical trials. 4,110 (33.7%) were in the pre-TAVR PCI group, 51.4% were females, and mean age was 81.9 years. The 30-day mortality was 5.2% versus 5.0% in patients with versus without pre-TAVR PCI, respectively [OR= 1.19 (95% CI: 0.91-1.55, P= 0.20)]. Pooled 1-year mortality was 18.1% versus 19.1% in patients with versus without pre-TAVR PCI (OR= 1.12, 95% CI: 0.95-1.31, P= 0.61). There was no significant difference between the groups for myocardial infarction, stroke, acute kidney injury, pacemaker implantation, or re-hospitalization. Pre-TAVR PCI was associated with an increased risk of life-threatening bleeding at 30 days. CONCLUSION: Pre-TAVR revascularization with PCI was not associated with improved 30-day or 1-year mortality; however, it was associated with an increased risk of life-threatening bleeding at 30-day post-TAVR. Our results do not support routine revascularization with PCI prior to TAVR with coexisting CAD. Future trials addressing anatomical complexity and symptom burden may help better risk stratify patients who may benefit from pre-TAVR revascularization.

Cardiovascular Outcomes in Aortopathy: GenTAC Registry of Genetically Triggered Aortic Aneurysms and Related Conditions.

BACKGROUND: The GenTAC (Genetically Triggered Thoracic Aortic Aneurysm and Cardiovascular Conditions) Registry enrolled patients with genetic aortopathies between 2007 and 2016. OBJECTIVES: The purpose of this study was to compare age distribution and probability of elective surgery for proximal aortic aneurysm, any dissection surgery, and cardiovascular mortality among aortopathy etiologies. METHODS: The GenTAC study had a retrospective/prospective design. Participants with bicuspid aortic valve (BAV) with aneurysm (n = 879), Marfan syndrome (MFS) (n = 861), nonsyndromic heritable thoracic aortic disease (nsHTAD) (n = 378), Turner syndrome (TS) (n = 298), vascular Ehlers-Danlos syndrome (vEDS) (n = 149), and Loeys-Dietz syndrome (LDS) (n = 121) were analyzed. RESULTS: The 25% probability of elective proximal aortic aneurysm surgery was 30 years for LDS (95% CI: 18-37 years), followed by MFS (34 years; 95% CI: 32-36 years), nsHTAD (52 years; 95% CI: 48-56 years), and BAV (55 years; 95% CI: 53-58 years). Any dissection surgery 25% probability was highest in LDS (38 years; 95% CI: 33-53 years) followed by MFS (51 years; 95% CI: 46-57 years) and nsHTAD (54 years; 95% CI: 51-61 years). BAV experienced the largest relative frequency of elective surgery to any dissection surgery (254/33 = 7.7), compared with MFS (273/112 = 2.4), LDS (35/16 = 2.2), or nsHTAD (82/76 = 1.1). With MFS as the reference population, risk of any dissection surgery or cardiovascular mortality was lowest in BAV patients (HR: 0.13; 95% CI: 0.08-0.18; HR: 0.13; 95%: CI: 0.06-0.27, respectively). The greatest risk of mortality was seen in patients with vEDS. CONCLUSIONS: Marfan and LDS cohorts demonstrate age and event profiles congruent with the current understanding of syndromic aortopathies. BAV events weigh toward elective replacement with relatively few dissection surgeries. Nonsyndromic HTAD patients experience near equal probability of dissection vs prophylactic surgery, possibly because of failure of early diagnosis.

The prevalence, operations, and outcomes of carcinoid heart disease.

BACKGROUND: Carcinoid heart disease (CHD) is a sequela of carcinoid liver metastases (LM). The true prevalence of CHD is unknown due to infrequent screening by transthoracic echocardiography (TTE). Octreotide is believed to protect against new and recurrent CHD, but supporting data are scant. This study determined CHD prevalence and outcomes in patients screened by TTE and treated with octreotide. METHODS: Records of carcinoid patients from 2001 to 2021 were reviewed. Survival was estimated by Kaplan-Meyer curves and compared by log-rank. RESULTS: Among 282 patients screened by TTE, overall survival was lower in CHD (n = 40) versus non-CHD (n = 242) patients (p < 0.001). Despite octreotide therapy, 21 patients developed CHD. Among patients with inoperable LM, survival was lower in CHD patients without valve replacement (VR) (p < 0.001), but similar between CHD patients with VR and non-CHD patients. CHD patients with VR and hepatic cytoreduction had survival similar to CHD patients without VR. CONCLUSION: VR improves survival in CHD patients with inoperable LM. Hepatic cytoreduction after VR should be reserved for carefully selected cases. Our data do not support a protective effect of octreotide.

Propensity-Matched 1-Year Outcomes Following Transcatheter Aortic Valve Replacement in Low-Risk Bicuspid and Tricuspid Patients.

OBJECTIVES: The aim of this study was to compare 1-year outcomes after transcatheter aortic valve replacement (TAVR) in low surgical risk patients with bicuspid aortic stenosis to patients with tricuspid aortic stenosis. BACKGROUND: The pivotal TAVR trials excluded patients with bicuspid aortic valves. The Low Risk Bicuspid Study 30-day primary endpoint of death or disabling stroke was 1.3%. METHODS: The Low Risk Bicuspid Study is a prospective, single-arm, TAVR trial that enrolled patients from 25 U.S. sites. A screening committee confirmed bicuspid anatomy and valve classification on computed tomography using the Sievers classification. Valve sizing was by annular measurements. An independent clinical events committee adjudicated all serious adverse events, and an independent core laboratory assessed all echocardiograms. The 150 patients from the Low Risk Bicuspid Study were propensity matched to the TAVR patients in the randomized Evolut Low Risk Trial using the 1:1 5- to-1-digit greedy method, resulting in 145 pairs. RESULTS: All-cause mortality or disabling stroke at 1 year was 1.4% in the bicuspid and 2.8% in the tricuspid group (P = 0.413). A pacemaker was implanted in 16.6% of bicuspid and 17.9% of tricuspid patients (P = 0.741). The effective orifice area was similar between groups at 1 year (2.2 ± 0.7 cm2 vs 2.3 ± 0.6 cm2, P = 0.677) as was the mean gradient (8.7 ± 3.9 mm Hg vs 8.5 ± 3.1 mm Hg, P = 0.754). Fewer patients in the bicuspid group had mild or worse paravalvular leak (21.3% vs 42.6%, P < 0.001). CONCLUSIONS: There were no significant differences in clinical or forward flow hemodynamic outcomes between the propensity-matched groups at 1 year.

TAVR operator volumes, trends, and geographic variations amongst Medicare beneficiaries in the United States.

OBJECTIVES: To evaluate transcatheter aortic valve replacement (TAVR) operator procedural volumes, and describe temporal and geographic trends. BACKGROUND: TAVR is the standard of care for most patients with severe symptomatic aortic stenosis. Despite an association between operator procedural volume and outcomes, nationwide TAVR operator volumes have been incompletely described. METHODS: We queried the National Medicare Provider Utilization and Payment Database for transfemoral TAVRs from 2014 to 2018. Annual operator volume, state and regional volumes, and longitudinal trends were extracted and analyzed using descriptive statistics. RESULTS: In 2018, the mean annual operator volume was 23.6 TAVRs. The highest 1% of operators by volume performed 7.6% of total TAVR procedures in the United States, while 35.7% of operators performed 10 or fewer TAVRs per year. From 2014 to 2018, there was a 53.9% annualized increase in TAVRs, and the mean annual volume per operator grew from 12.5 to 23.6. There was more than five-fold variability in the density of operators (range 0.35-1.79 operators per 100,000 population) and mean operator volume by state (range 14.2-52.4 TAVRs per operator). CONCLUSIONS: In this nationally representative study of operators performing transfemoral TAVRs among Medicare patients, we found the mean annual volume of TAVR in 2018 to be 23.6 and has increased since 2014. There was considerable variability in operator density and procedural volumes, with a significant proportion of operators performing 10 or fewer TAVRs per year. Ambiguity remains in regard to the optimal balance of procedural requirements to sustain high efficacy outcomes and ensure critical access to TAVR therapies.