Suri, Rakesh M.

Introduction Moderate mitral regurgitation (MR) of ischemic etiology has been associated with worse outcomes after coronary artery bypass grafting (CABG). Studies comparing concomitant mitral valve replacement/repair (MVR/Re) with CABG and standalone CABG have reported conflicting results. We performed a systematic review and meta-analysis of the published literature. Patients and Methods We searched using PubMed, Cochrane, EMBASE, CINAHL, and Google scholar databases from January 1960 to June 2016 for clinical trials comparing CABG to CABG + MVR/Re for moderate MR. Pooled risk ratio or mean difference (MD) with 95% confidence intervals (CI) for individual outcomes were calculated using random effects model and heterogeneity was assessed using Cochrane's Q-statistic. Results A total of 11 studies were included. Mean follow-up was 35.3 months. All-cause mortality (Mantel–Haenszel [MH] risk ratio [RR]: 0.96, 95% CI: 0.75–1.24, p = 0.775), early mortality (MH RR: 0.65, 95% CI: 0.39–1.07, p = 0.092), and stroke rates (MH RR 0.65, 95% CI: 0.21–2.03, p = 0.464) were similar between CABG and CABG + MVR/Re groups. Adverse event at follow-up was lower with CABG (MH RR: 0.90, 95% CI: 0.61–1.32, p = 0.584). MD of change from baseline in left ventricular (LV) end-systolic dimension (MD: − 2.50, 95% CI: − 5.21 to − 0.21, p = 0.071) and LV ejection fraction (MD: 0.48, 95% CI: − 2.48 to 3.44, p = 0.750) were not significantly different between the groups. Incidence of moderate MR (MH RR: 3.24, 95% CI: 1.79–5.89, p < 0.001) was higher in the CABG only group. Conclusion Addition of MVR/Re to CABG in patients with moderate ischemic MR did not result in improvement in early or overall mortality, stroke risk, or intermediate markers of LV function when compared with CABG alone.

Background: Mitral valve (MV) repair is preferred over replacement in clinical guidelines and is an important determinant of the indication for surgery in degenerative mitral regurgitation. However, the level of evidence supporting current recommendations is low, and recent data cast doubts on its validity in the current era. Accordingly, the aim of the present study was to analyze very long-term outcome after MV repair and replacement for degenerative mitral regurgitation with a flail leaflet. Methods: MIDA (Mitral Regurgitation International Database) is a multicenter registry enrolling patients with degenerative mitral regurgitation with a flail leaflet in 6 tertiary European and US centers. We analyzed the outcome after MV repair (n=1709) and replacement (n=213) overall, by propensity score matching, and by inverse probability-of-treatment weighting. Results: At baseline, patients undergoing MV repair were younger, had more comorbidities, and were more likely to present with a posterior leaflet prolapse than those undergoing MV replacement. After propensity score matching and inverse probability-of-treatment weighting, the 2 treatments groups were balanced, and absolute standardized differences were usually <10%, indicating adequate match. Operative mortality (defined as a death occurring within 30 days from surgery or during the same hospitalization) was lower after MV repair than after replacement in both the entire population (1.3% versus 4.7%; P <0.001) and the propensity-matched population (0.2% versus 4.4%; P <0.001). During a mean follow-up of 9.2 years, 552 deaths were observed, of which 207 were of cardiovascular origin. Twenty-year survival was better after MV repair than after MV replacement in both the entire population (46% versus 23%; P <0.001) and the matched population (41% versus 24%; P <0.001). Similar superiority of MV repair was obtained in patient subsets on the basis of age, sex, or any stratification criteria (all P <0.001). MV repair was also associated with reduced incidence of reoperations and valve-related complications. Conclusions: Among patients with degenerative mitral regurgitation with a flail leaflet referred to mitral surgery, MV repair was associated with lower operative mortality, better long-term survival, and fewer valve-related complications compared with MV replacement.

Background Sex‐related differences in morbidity and survival in bicuspid aortic valve (BAV) adults are fundamentally unknown. Contemporary studies portend excellent survival for BAV patients identified at early echocardiographic‐clinical stages. Whether BAV adults incur a survival disadvantage throughout subsequent echocardiographic‐clinical stages remains undetermined. Methods and Results Analysis was done of 3 different cohorts of consecutive patients with echocardiographic diagnosis of BAV identified retrospectively: (1) a community cohort of 416 patients with first BAV diagnosis (age 35±21 years, follow‐up 16±7 years), (2) a tertiary clinical referral cohort of 2824 BAV adults (age 51±16 years, follow‐up 9±6 years), and (3) a surgical referral cohort of 2242 BAV adults referred for aortic valve replacement (AVR) (age 62±14 years, follow‐up 6±5 years). For the community cohort, 20‐year risks of aortic regurgitation (AR), AVR, and infective endocarditis were higher in men (all P ≤0.04); for a total BAV‐related morbidity risk of 52±4% vs 35±6% in women ( P =0.01). The cohort's 25‐year survival was identical to that in the general population ( P =0.98). AR independently predicted mortality in women ( P =0.001). Baseline AR was more common in men ( P ≤0.02) in the tertiary cohort, with 20‐year survival lower than that in the general population ( P <0.0001); age‐adjusted relative death risk was 1.16 (95% confidence interval [CI] 1.05‐1.29) for men versus 1.67 (95% CI 1.38‐2.03) for women ( P =0.001). AR independently predicted mortality in women ( P =0.01). Baseline AR and infective endocarditis were higher in men (both ≤0.001) for the surgical referral cohort, with 15‐year survival lower than that in the general population ( P <0.0001); age‐adjusted relative death risk was 1.34 (95% CI 1.22‐1.47) for men versus 1.63 (95% CI 1.40‐1.89) for women ( P =0.026). AR and NYHA class independently predicted mortality in women (both P ≤0.04). Conclusions Within evolving echocardiographic‐clinical stages, the long‐term survival of adults with BAV is not benign, as both men and women incur excess mortality. Although BAV‐related morbidity is higher in men in the community, and AR and infective endocarditis are more prevalent in men, women exhibit a significantly higher relative risk of death in tertiary and surgical referral cohorts, which is independently associated with AR.

Background— Lead-related or valve-related endocarditis can complicate cardiovascular implantable electronic device (CIED) infection in patients with both CIED and prosthetic valves. The objective of this study was to determine the outcomes of transvenous lead extraction for CIED infection in patients with prosthetic valves. Methods and Results— We retrospectively screened 794 transvenous lead extraction procedures, between September 1, 2001 and August 31, 2012, at Mayo Clinic to identify patients with prosthetic valves who underwent lead extraction for infection. Demographic, clinical, and follow-up characteristics were analyzed. In total, 51 patients (6%) met the study inclusion criteria, of whom 20 had pocket infection and 31 had lead-related or valve-related, or both, endocarditis or bloodstream infection (mean age, 67 [18] years). Staphylococcal species were the most common pathogens, including Staphylococcus aureus in 20 cases (39%) and coagulase-negative staphylococci in 19 cases (37%). Overall, 127 transvenous leads (median lead age, 52 months) were extracted. Of these leads, 123 (97%) were removed completely. The in-hospital mortality rate was 9.8%; no deaths were attributable to the extraction procedure. Ninety-five percent of patients who survived had no evidence of recurrent device-related or valve-related infection. Conclusions— Transvenous lead extraction seems safe and curative in patients with CIED infection and prosthetic valves. Cure of infection can be achieved in the majority of patients with complete CIED removal and antimicrobial therapy and without valve surgery.

Objective To define the benefit of sutureless and rapid deployment valves in current minimally invasive approaches in isolated aortic valve replacement. Methods A panel of 28 international experts with expertise in both minimally invasive aortic valve replacement and rapid deployment valves was constituted. After thorough literature review, the experts rated evidence-based recommendations in a modified Delphi approach. Results No guideline could be retrieved. Thirty-three clinical trials and 9 systematic reviews could be identified for detailed text analysis to obtain a total of 24 recommendations. After rating by the experts 12, final recommendations were identified: preoperative computed to-mographic scan as well as intraoperative transesophageal echocardiography are highly recommended. Suitable annular sizes are 19 to 27 mm. There is a contraindication for bicuspid valves only for type 0 and for annular abscess or destruction due to infective endocarditis. The use of sutureless and rapid deployment valves reduces extracorporeal circulation and aortic cross-clamp time and leads to less early complications as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions, paravalvular leakages and aortic regurgitation, and renal replacement therapy, respectively. These clinical outcomes result in reduced intensive care unit and hospital stay and reduced costs. The use of sutureless and rapid deployment valves will lead to a higher adoption rate of minimally invasive approaches in aortic valve replacement. Respect should be taken to a necessary short learning curve for both sutureless and minimally invasive programs. Conclusions Sutureless and rapid deployment aortic valve replacement together with minimally invasive approaches offers an attractive option in aortic valve placement for patients requiring biological valve replacement.

Background— Severe primary (degenerative) mitral regurgitation (MR) is repaired with durable results when simple single-scallop disease is addressed. The midterm quality outcomes of minimally invasive repair for complex disease are unknown, however. Methods and Results— From January 2008 to January 2015, 487 patients (56±11 years, 360 men, ejection fraction 65±6%, 98.8% complete follow-up) underwent robotic mitral valve repair for severe nonischemic degenerative MR. Simple pathology was addressed in 289 of 487 (59%) patients, and complex repair (all others) was performed in 198 of 487 (41%). Four patients died during follow-up with a 5-year survival rate 99.5% (99.4% simple; 99.5% complex; hazard ratio, 0.48; 95% confidence interval, 0.05–4.59); and New York Heart Association functional class I/II was documented in 97.9% (477/487). Eight patients had recurrence of moderate-to-severe MR (4 simple, 4 complex), with a 5-year freedom from MR of 94.6% (96.2% simple; 92.7%, complex; P =0.67; hazard ratio, 1.36; 95% confidence interval, 0.34–5.43). Seven patients (2 simple, 5 complex), underwent mitral reoperation, with a 5-year freedom from reoperation of 97.7% (99.1% simple; 95.7% complex; P =0.13; hazard ratio, 3.35; 95% confidence interval, 0.65–17.32). Conclusions— At a large tertiary care referral center, midterm quality outcomes after robotic correction of degenerative MR are excellent, with very high survival, infrequent complications, and a low likelihood of MR recurrence, regardless of mitral valve repair complexity. Awareness of these improvements in outcome is important to inform contemporary decisions regarding high-quality alternatives to conventional and percutaneous mitral repair.

ObjectivesTo identify number of cases needed to maximize device success and minimize adverse events after transfemoral transcatheter aortic valve replacement (TF‐TAVR), and determine if adverse events were linked to the technical performance learning curve.BackgroundTF‐TAVR is a complex procedure with an incompletely characterized learning curve for clinical outcomes.MethodsFrom 4/2007–2/2012, 1521 patients underwent TF‐TAVR in the PARTNER‐I trial. Outcomes learning curves were defined as number of cases needed to reach a plateau for device success, adverse events, and post‐procedure length of stay. Institutional variation was accounted for by mixed‐model non‐linear techniques, which were also used to identify contribution of the procedure time learning curve to 30‐day major adverse events and length of stay.ResultsEighty percent device success was achieved after 22 cases; major vascular complications fell below 5% after 70 cases and major bleeding below 10% after 25 cases. It took an average of 28 cases to achieve a consistent low risk of 30‐day major adverse events, but institutions entering in the middle of the trial achieved it after about 26. The most significant correlate of 30‐day major adverse events and post‐procedure length of stay was procedure time (P < 0.0001). However, this association was related to patient and unmeasured variables, not the procedure time learning curve (P = 0.6).ConclusionsBy end of trial, a consistent low risk of adverse events was achieved after ∼26 cases. However, these improved results were due to change in patient risk profile; outcomes were not linked to the technical performance learning curve. © 2015 Wiley Periodicals, Inc.

Coexistence of end‐stage liver disease (ESLD) and severe valvular heart disease conveyed substantial risk for patients, oftentimes leading to exclusion from liver transplantation candidacy due to inability to safely offer cardiac surgery prior to transplantation. Several approaches have been described, including performing transplantation and valve surgery concurrently, or in sequence. Both options, however, have associated complications: catastrophic repercussion of peri‐operative coagulopathy and organ dysfunction post‐transplantation, respectively. The introduction of transcatheter procedures offered a safer alternative for high‐risk patients; however, its recognized indications remained limited. A novel approach to this surgical dilemma by performing transcatheter aortic valve replacement (TAVR) for severe native aortic valve regurgitation in a patient on the liver transplant list has been presented. The procedure proved to be an effective management for the aortic valve insufficiency, improving our patient's hemodynamics in preparation for the subsequent orthotopic liver transplantation (OLT). © 2015 Wiley Periodicals, Inc.

Objective Pulmonary hypertension (PH) is associated with increased mortality after surgical or transcatheter aortic valve replacement (TAVR) for aortic stenosis (AS), and when the pulmonary artery pressure is particularly elevated, there may be questions about the clinical benefit of TAVR. We aimed to identify clinical and haemodynamic factors associated with increased mortality after TAVR among those with moderate/severe PH. Methods Among patients with symptomatic AS at high or prohibitive surgical risk receiving TAVR in the Placement of Aortic Transcatheter Valves (PARTNER) I randomised trial or registry, 2180 patients with an invasive measurement of mean pulmonary artery pressure (mPAP) recorded were included, and moderate/severe PH was defined as an mPAP ≥35 mm Hg. Results Increasing severity of PH was associated with progressively worse 1-year all-cause mortality: none (n=785, 18.6%), mild (n=838, 22.7%) and moderate/severe (n=557, 25.0%) (p=0.01). The increased hazard of mortality associated with moderate/severe PH was observed in females, but not males (interaction p=0.03). In adjusted analyses, females with moderate/severe PH had an increased hazard of death at 1 year compared with females without PH (adjusted HR 2.14, 95% CI 1.44 to 3.18), whereas those with mild PH did not. Among males, there was no increased hazard of death associated with any severity of PH. In a multivariable Cox model of patients with moderate/severe PH, oxygen-dependent lung disease, inability to perform a 6 min walk, impaired renal function and lower aortic valve mean gradient were independently associated with increased 1-year mortality (p<0.05 for all), whereas several haemodynamic indices were not. A risk score, including these factors, was able to identify patients with a 15% vs 59% 1-year mortality. Conclusions The relationship between moderate/severe PH and increased mortality after TAVR is altered by sex, and clinical factors appear to be more influential in stratifying risk than haemodynamic indices. These findings may have implications for the evaluation of and treatment decisions for patients referred for TAVR with significant PH. Trial registration NCT00530894.

ObjectivesTo assess technical performance learning curves of teams performing transfemoral transcatheter aortic valve replacement (TF‐TAVR).BackgroundTF‐TAVR is a new procedure for treating severe aortic stenosis. The number of cases required for procedural efficiency is unknown.MethodsIn the PARTNER‐I trial, 1,521 patients underwent TF‐TAVR from 4/2007–2/2012. Learning curve analysis of technical performance metrics was performed using institution‐specific patient sequence number, interval between procedures, and institutional trial entry date. Learning curve characteristics were assessed using semi‐parametric and parametric mixed‐effects models.ResultsAs patient sequence number increased, average procedure time decreased from 154 to 85 minutes (P < 0.0001), and fluoroscopy time from 28 to 20 minutes (P < 0.0001). Procedure time plateaued at an average of 83 minutes (range 52–140). Procedure time plateau was dynamic during the course of the trial, averaging 25 cases (range 21–52) by its end. The later institutions enrolled in the trial, the shorter the initial procedure time. During the trial, percutaneous rather than surgical access increased from 7.9% to 69%.ConclusionsTechnical performance learning curves exist for TF‐TAVR; procedural efficiency increased with experience, with concomitant decreases in radiation and contrast media exposure. The number of cases needed to achieve efficiency decreased progressively, with optimal procedural performance reached after approximately 25 cases for late‐entering institutions. Knowledge and experience accumulated by early TF‐TAVR institutions were disseminated, shortening the learning curve of late‐entering institutions. Technological advances resulting from learning during the trial moved the field from initial conservative surgical cut‐down to percutaneous access for most patients. © 2015 Wiley Periodicals, Inc.