Randomized Feasibility Trial of Prophylactic Radiofrequency Ablation to Prevent Atrial Fibrillation after Cardiac Surgery.

OBJECTIVE: Evaluate the feasibility of prophylactic radiofrequency isolation of the pulmonary veins, with left atrial appendage amputation, to reduce the incidence of postoperative atrial fibrillation (POAF) after cardiac surgery in patients aged 70 and older. METHODS: The Federal Food and Drug Administration granted an investigational device exemption to utilize a bipolar radiofrequency clamp for prophylactic pulmonary vein isolation in a limited, feasibility trial. Sixty-two patients without prior dysrhythmias, were prospectively randomized to undergo either their index cardiac surgical procedure, or bilateral pulmonary vein isolation and left atrial appendage amputation during their cardiac operation. The primary outcome was occurrence of in-hospital POAF. Subjects were on 24-hour telemetry until discharge. Dysrhythmias, any episode of atrial fibrillation > 30 seconds, were confirmed by electrophysiologists blinded to the study. RESULTS: Sixty patients, mean age 75 years and mean CHA2DS2-VASc score 4, were analyzed. Thirty-one patients randomized to control and twenty-nine to the treatment group. Majority of cases in each group were isolated CABG. No perioperative complications related to the treatment procedure, need for permanent pacemaker, or mortality occurred. The in-hospital incidence of POAF was 55% (17/31) in the control group and 7% (2/29) in the treatment group. (p<0.001) The control group had a significantly higher requirement for antiarrhythmic medications at discharge, 45% (14/31) vs 7% (2/29) in the treatment group (p<0.001). CONCLUSIONS: Prophylactic radiofrequency isolation of the pulmonary veins with left atrial appendage amputation, during the primary cardiac surgical operation, reduced the incidence of POAF in patients 70 years and older with no history of atrial arrhythmias.

Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients: 5-Year Outcomes of the SURTAVI Randomized Clinical Trial.

Importance: In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. Objective: To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. Design, Setting, and Participants: SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Intervention: Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. Main Outcomes and Measures: The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. Results: A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P < .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm2 vs 1.8 [0.6] cm2; P < .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P < .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Conclusions and Relevance: Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.

2-Year Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients.

BACKGROUND: The Evolut Low Risk Trial (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients) showed that transcatheter aortic valve replacement (TAVR) with a supra-annular, self-expanding valve was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years. This finding was based on a Bayesian analysis performed after 850 patients had reached 1 year of follow-up. OBJECTIVES: The goal of this study was to report the full 2-year clinical and echocardiographic outcomes for patients enrolled in the Evolut Low Risk Trial. METHODS: A total of 1,414 low-surgical risk patients with severe aortic stenosis were randomized to receive TAVR or surgical AVR. An independent clinical events committee adjudicated adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints. RESULTS: An attempted implant was performed in 730 TAVR and 684 surgical patients from March 2016 to May 2019. The Kaplan-Meier rates for the complete 2-year primary endpoint of death or disabling stroke were 4.3% in the TAVR group and 6.3% in the surgery group (P = 0.084). These rates were comparable to the interim Bayesian rates of 5.3% with TAVR and 6.7% with surgery (difference: -1.4%; 95% Bayesian credible interval: -4.9% to 2.1%). All-cause mortality rates were 3.5% vs 4.4% (P = 0.366), and disabling stroke rates were 1.5% vs 2.7% (P = 0.119), respectively. Between years 1 and 2, there was no convergence of the primary outcome curves. CONCLUSIONS: The complete 2-year follow-up from the Evolut Low Risk Trial found that TAVR is noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke, with event rates that were slightly better than those predicted by using the Bayesian analysis. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients [Evolut Low Risk Trial]; NCT02701283).

Long-term outcomes of etiology specific annuloplasty ring repair of ischemic mitral regurgitation.

BACKGROUND: Reductive annuloplasty repair of ischemic mitral regurgitation (IMR) is associated with high rates of recurrent MR, which may be improved with etiology-specific annuloplasty rings. METHODS: From October 2005 to May 2015, 128 consecutive patients underwent repair of IMR with the GeoForm ring. Clinical data was extracted from our local Society of Thoracic Surgeons database and electronic medical records. Mortality data was obtained from the Michigan State Social Security Death Index. RESULTS: The average age of patients was 65±11 years with mean pre-op left ventricular ejection fraction (LVEF) of 30%±10% and MR grade of 3.1±0.9 (0-4+). Thirty-day mortality was 4.7%, rate of renal failure 7.9%, rate of atrial fibrillation 27.3%, and no strokes were observed. Of the surviving patients, 89% (109/122) had a follow-up echocardiogram beyond 1 month with a mean echocardiographic follow-up of 59±39 months. LVEF improved from 30%±10% to 38%±14%, P<0.001) while end-diastolic (5.9±0.0 to 5.3±0.9 cm, P<0.001) and end-systolic (5.0±1.0 to 4.4±1.1 cm, P<0.001) left ventricular (LV) diameters decreased, as compared to pre-operative values. Seven patients were found to have recurrent moderate or greater IMR in follow-up to 10 years with three being due to ring dehiscence. One-, 5-, and 10-year freedom from recurrent moderate or severe IMR was 98%, 94%, and 80% respectively. One-, 5-, and 10-year survival was 91%, 77%, and 44%, respectively. CONCLUSIONS: Overall, etiology-specific ring repair of IMR was associated with low rates of recurrent MR on long-term follow-up, coupled with significant LV reverse remodeling and improvement in ejection fraction.

Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients.

BACKGROUND: Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients. METHODS: We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk. When 850 patients had reached 12-month follow-up, we analyzed data regarding the primary end point, a composite of death or disabling stroke at 24 months, using Bayesian methods. RESULTS: Of the 1468 patients who underwent randomization, an attempted TAVR or surgical procedure was performed in 1403. The patients' mean age was 74 years. The 24-month estimated incidence of the primary end point was 5.3% in the TAVR group and 6.7% in the surgery group (difference, -1.4 percentage points; 95% Bayesian credible interval for difference, -4.9 to 2.1; posterior probability of noninferiority >0.999). At 30 days, patients who had undergone TAVR, as compared with surgery, had a lower incidence of disabling stroke (0.5% vs. 1.7%), bleeding complications (2.4% vs. 7.5%), acute kidney injury (0.9% vs. 2.8%), and atrial fibrillation (7.7% vs. 35.4%) and a higher incidence of moderate or severe aortic regurgitation (3.5% vs. 0.5%) and pacemaker implantation (17.4% vs. 6.1%). At 12 months, patients in the TAVR group had lower aortic-valve gradients than those in the surgery group (8.6 mm Hg vs. 11.2 mm Hg) and larger effective orifice areas (2.3 cm2 vs. 2.0 cm2). CONCLUSIONS: In patients with severe aortic stenosis who were at low surgical risk, TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery with respect to the composite end point of death or disabling stroke at 24 months. (Funded by Medtronic; ClinicalTrials.gov number, NCT02701283.).

The Midterm Impact of Transcatheter Aortic Valve Replacement on Surgical Aortic Valve Replacement in Michigan.

BACKGROUND: We characterized the midterm impact of transcatheter aortic valve replacement (TAVR) on surgical aortic valve replacement (SAVR) volume, patient profiles, and outcomes in Michigan. METHODS: We analyzed data obtained after SAVR (n = 15,288) and TAVR (n = 1,783) using the Michigan Society of Thoracic and Cardiovascular Surgery Quality Collaborative from 2006 to 2015. During this period, 17 of 33 hospitals developed TAVR programs. RESULTS: Annual SAVR volume increased by 38.1% at TAVR hospitals and by 20.4% at non-TAVR hospitals, (p trend < 0.001). In TAVR hospitals, the Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) decreased before (4.7% ± 5.1%) and after (3.5% ± 3.6%) initiation of TAVR (p < 0.001). Rates of 30-day mortality (pre-TAVR, 3.9% vs post-TAVR, 2.7%; p < 0.001) and renal failure (pre-TAVR, 5.2% vs post-TAVR, 3.3%; p < 0.001) but not stroke (pre-TAVR, 1.9% vs post-TAVR, 1.7%; p = 0.47) were lower after TAVR implementation. Length of stay decreased from 9.0 to 8.5 days (p < 0.001). When analyzing high-risk patients undergoing SAVR (ie, PROM >8%), neither mortality, stroke, nor renal failure was different (all p > 0.15). Despite a reduction in the STS-PROM, non-TAVR hospitals did not display changes in mortality, stroke, or renal failure for either the entire or the high-risk SAVR cohorts after initiation of TAVR in Michigan. CONCLUSIONS: TAVR implementation in Michigan has dramatically increased overall SAVR volume. This phenomenon has occurred with a concomitant decrease in preoperative risk profile and has improved early SAVR outcomes, particularly at TAVR hospitals, but surprisingly not in patients considered at high preoperative risk. As TAVR use increases, these issues may be further clarified and elucidated.

Aortic valve replacement in octogenarians with prior cardiac surgery.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been advocated for very elderly patients with aortic stenosis, and prior cardiac surgery as a less invasive treatment option. Although surgical aortic valve replacement (AVR) is safe and effective in selected elderly patients, the perioperative and mid-term outcomes of AVR in very elderly with prior cardiac surgery are unknown. METHODS: The Society of Thoracic Surgeons (STS) Database at our center enrolled 3,735 patients after AVR since 1997. In this time interval, we identified 61 patients 80 years and older who underwent AVR for severe AS or failed aortic bioprosthesis after having prior cardiac surgery. All clinical parameters were derived from the STS database. Follow-up mortality was assessed using the Social Security Death Index. RESULTS: The average age of the patients was 83 ± 2 years, 77% were male, and 75% underwent an isolated coronary artery bypass graft (CABG) as their first cardiac procedure. The mean ejection fraction was 0.53 ± 0.13. The CABG was performed concurrently in 49% of patients at the time of redo sternotomy and AVR. Stented bioprosthesis was implanted in 61% of patients and stentless in 39%. Perioperative mortality was 1.6% (1 of 61). One, 3, 5, and 7 year survival rates were 85%, 69%, 63%, and 43%, respectively. Patients with AVR only had similar survival to patients who underwent concomitant AVR and CABG. Type of aortic prosthesis did not influence postoperative survival. CONCLUSIONS: In selected patients over the age of 80 with history of prior cardiac surgery, AVR can be performed safely with very good mid-term outcomes. Age alone should not be exclusion criteria for surgical AVR in octogenarians with prior cardiac surgery.

Five-year real world outcomes of GeoForm ring implantation in patients with ischemic mitral regurgitation.

BACKGROUND: Reductive ring annuloplasty represents the current standard surgical therapy for ischemic mitral regurgitation (IMR); however, the clinical results have been suboptimal. Etiology-specific prostheses such as the GeoForm annuloplasty ring have been designed to better address the annular and subvalvular perturbations associated with IMR. However, clinical experience is limited, and mid-term results are lacking. METHODS: We reviewed the clinical outcomes of 86 patients who had undergone implantation of a GeoForm ring at our center from 2005 to 2011. Perioperative mortality and clinical parameters were derived from The Society of Thoracic Surgeons database. Follow-up survival was assessed using the Social Security Death Index. Surviving patients were interviewed by telephone for valve-specific follow-up data and to complete the Medical Outcomes Study, short-form, 36-item, quality-of-life questionnaire. RESULTS: The mean grade of IMR preoperatively was 3.1±0.8 (range, 1-4+), 0.2±0.4 in the immediate postoperative period, and 0.7±0.7 at the last mean follow-up point of 41 months; only 2 patients developed ≥2+IMR during the follow-up period, for a 5-year freedom from recurrent 2+ IMR of 86%. The mean left ventricular end-diastolic and end-systolic diameters decreased from before to after surgery from 6.0±0.0 cm to 5.3±09 cm and 5.0±0.9 cm to 4.3±1.1 cm, respectively (P<.001). Perioperative mortality was 5.8% (5 of 86), and 1-, 3-, and 5-year survival was 87%, 81%, and 75%, respectively. At the last follow-up point, 80% of patients were in New York Heart Association class I and II, and their quality of life was equal to, or better than, age-matched controls from the general population. CONCLUSIONS: Implantation of the GeoForm ring offers very good control of IMR, with low rate of recurrent IMR at mid-term follow-up. The use of this prosthesis was associated with good perioperative mortality, mid-term survival, and quality of life.

Stentless root bioprosthesis for repair of acute type A aortic dissection.

OBJECTIVE: The superior hemodynamics and excellent long-term clinical performance of stentless xenografts are well described. However, the early and midterm clinical outcomes of stentless valves in patients with acute type A dissection are widely unknown. The current study evaluated the early and midterm clinical outcomes of stentless bioprosthesis for repair of acute type A aortic dissection. METHODS: Between May 2005 and December 2009, 24 of 80 patients underwent root replacement using the Medtronic Freestyle xenograft (Medtronic Inc, Minneapolis, Minn) at the Meijer Heart Center. Prospective data collection was used for retrospective review. Univariate comparisons of preoperative, intraoperative, and postoperative variables were performed between patients who underwent stentless root bioprosthesis for the correction of acute type A aortic dissection (n = 24). RESULTS: The mean age of patients was 57 years, with 15 patients aged less than 65 years. Axillary and femoral artery cannulation were used in 16 patients (67%) and 7 patients (29%), respectively. Median crossclamp and cardiopulmonary bypass times were 198 minutes (92-480 minutes) and 288 minutes (109-588 minutes), respectively. Median circulatory arrest time was 28 minutes (24-50 minutes). Operative mortality rate was 25%. Actuarial 5-year survival was 62.5%. No patients required redo aortic root replacement. CONCLUSIONS: Stentless valve implantation can be accomplished with satisfactory early and midterm clinical outcomes and is a valuable option in patients with acute aortic dissection who require root replacement.

Endovascular repair of traumatic thoracic aortic tears.

BACKGROUND: Patients with thoracic aorta injuries (TAI) present a unique challenge. The purpose of this study was to review the outcomes of thoracic endovascular aortic repair (TEVAR) in patients with TAI. METHODS: A retrospective chart review of all patients admitted for TEVAR for trauma was performed. RESULTS: In a 5-year period, 19 patients (6 women and 13 men; average age, 42 y) were admitted to our trauma center with TAI. Mechanism of injury was a motor vehicle crash in 12 patients, motorcycle crash in 2 patients, automobile-pedestrian accident in 2 patients, 1 fall, 1 crush injury, and 1 stab wound to the back. A thoracic endograft was used in 6 patients and proximal aortic cuffs were used in 13 patients (68%). One patient (5%) died. There were no strokes, myocardial infarctions, paraplegia, or renal failure. CONCLUSIONS: TEVAR for TAI appears to be a safe option for patients with multiple injuries. TEVAR in young patients is still controversial because long-term endograft behavior is unknown.

Impact of dexmedetomidine on analgesic requirements in patients after cardiac surgery in a fast-track recovery room setting.

STUDY OBJECTIVE: To compare postoperative opioid requirements in patients who received dexmedetomidine versus propofol after cardiac surgery. DESIGN: Retrospective cohort study. SETTING: Large, community teaching hospital that uses a fast-track cardiovascular recovery unit (CVRU) model. PATIENTS: One hundred adults who underwent coronary artery bypass graft surgery and/or valvular surgery, and who received either dexmedetomidine (50 patients) or propofol (50 patients) for perioperative sedation. MEASUREMENTS AND MAIN RESULTS: Patients were matched according to surgery type and left ventricular ejection fraction. Opioid requirements were assessed over two time intervals: from arrival in the CVRU to discontinuation of the sedative infusion, and from CVRU arrival to CVRU discharge, up to a maximum of 72 hours if admission to the intensive care unit was necessary. All postoperative opioid doses were converted to morphine equivalents. Length of mechanical ventilation, quality of sedation, adverse drug events, and sedation-related costs were determined. Opioid requirements were significantly lower during the sedative infusion period for dexmedetomidine-treated patients than for propofol-treated patients (median [range] 0 [0-10 mg] vs 4 mg [0-33 mg], p<0.001), but not through the entire CVRU admission (median [range] 26 mg [0-119 mg] vs 30 mg (0-100 mg], p=0.284). The proportion of patients who did not require opioids during the infusion was significantly higher in the dexmedetomidine group compared with the propofol group (32 [64%] vs 13 [26%], p<0.001). No significant differences were noted between the groups for length of mechanical ventilation, quality of sedation, or adverse events. Sedation-related costs were significantly higher (approximately $50/patient higher) with dexmedetomidine (p<0.001). CONCLUSION: Dexmedetomidine resulted in lower opioid requirements in patients after cardiac surgery versus those receiving propofol, but this did not result in shorter durations of mechanical ventilation, using a fast-track CVRU model.

Cardiac surgeons and the quality movement: the Michigan experience.

The Michigan Society of Thoracic and Cardiovascular Surgeons created a voluntary quality collaborative with all the cardiac surgeons in the state and all hospitals doing adult cardiac surgery. Utilizing this collaborative over the last 3 years and creating a unique relationship with a payor, an approach to processes and outcomes has produced improvements in the quality of care for cardiac patients in the state of Michigan.