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Editorial Commentary: Balloons for Rotator Cuff Tears: A Viable Treatment or Just a Bunch of Hot Air?

      Abstract

      Rotator cuff tears are very common. They can be either traumatic or degenerative in nature. Many tears can be successfully treated nonoperatively with physical therapy or home exercises. For patients in whom conservative measures fail, there are a variety of ways to repair the rotator cuff. Despite our advances in knowledge about rotator cuff tears, improved technology, and advanced repair techniques, failure rates after surgery are still high. Large tears that are deemed irreparable can be treated with partial repair, debridement, tendon transfers such as a latissimus dorsi transfer or lower trapezius transfer, biceps tenotomy or tenodesis, superior capsular reconstruction, bridge grafting, or even arthroplasty options such as a hemiarthroplasty or reverse total shoulder arthroplasty. No technique has proved vastly superior to another, and there are many advantages and disadvantages of each surgical procedure. Add balloon spacer implantation to that list. A surgeon can now place a subacromial balloon spacer to help improve functional outcomes and reduce pain in patients with irreparable rotator cuff tears. Studies have shown promising results, with improvements in strength and range of motion, as well as reductions in pain. Outcomes have only been studied in the short term, so much is still unknown about the full effects of this treatment. More studies are needed to find out whether the results persist into the long term and to confirm that complications do not arise that may complicate future procedures such as a reverse total shoulder arthroplasty.
      Orthopaedists have learned a great deal about rotator cuff tears in the past decade or so. We have learned about patient-specific factors that influence healing rates, such as bone density,
      • Chung S.W.
      • Oh J.H.
      • Gong H.S.
      • Kim J.Y.
      • Kim S.H.
      Factors affecting rotator cuff healing after arthroscopic repair: Osteoporosis as one of the independent risk factors.
      hyperlipidemia,
      • Yamamoto N.
      • Mineta M.
      • Kawakami J.
      • Sano H.
      • Itoi E.
      Risk factors for tear progression in symptomatic rotator cuff tears: A prospective study of 174 shoulders.
      tear size, muscle atrophy, and chronicity. Some studies have shown that male sex, obesity, smoking, patient age, and vitamin D levels lead to a greater incidence of retears.
      • O'Donnell E.A.
      • Fu M.C.
      • White A.E.
      • et al.
      The effect of patient characteristics and comorbidities on the rate of revision rotator cuff repair.
      We have newer repair techniques including releases, patches, grafts, advanced suture anchors, and an ever-growing list of biologics to try to make repairs more successful. Despite all the knowledge and skills, there ends up being a subset of patients whose tears are just not repairable.
      There are several ways to address the irreparable rotator cuff tear, from nonoperative care to debridement, partial repair, biceps procedures, grafts, patches, tendon transfers, superior capsular reconstruction, and reverse total shoulder arthroplasty, to name only a few. A more recent technique to address these complicated tears is insertion of a subacromial balloon spacer arthroscopically or by a mini-open technique. Balloon spacers placed in the subacromial space have been allowed by the European Union for about a decade now. The first study on these spacers, performed by Savarese and Romeo,
      • Savarese E.
      • Romeo R.
      New solution for massive, irreparable rotator cuff tears: The subacromial “biodegradable spacer.”.
      was published in 2012 and showed very promising short-term results with few surgical complications. The InSpace Balloon (OrthoSpace, Caesarea, Israel) is a preshaped spacer made of poly-L-lactide-co-Ɛ-caprolactone. It is designed to absorb over a period of about 12 months and usually deflates by 3 months.
      • Holschen M.
      • Brand F.
      • Agneskirchner J.D.
      Subacromial spacer implantation for massive rotator cuff tears: Clinical outcome of arthroscopically treated patients.
      It is designed to help restore more normal shoulder biomechanics by depressing the humeral head.
      • Piekaar R.S.M.
      • Bouman I.C.E.
      • van kampen P.M.
      • van Eijk F.
      • Huijsmans P.E.
      The subacromial balloon spacer for massive irreparable rotator cuff tears: Approximately 3 years of prospective follow-up.
      Most of the studies in the literature have included only small numbers of patients and 1 or 2 years of follow-up.
      The article “Subacromial Balloon Spacer for Massive, Irreparable Rotator Cuff Tears Is Associated With Improved Shoulder Function and High Patient Satisfaction” by Familiari, Nayar, Russo, De Gori, Ranuccio, Mastroianni, Giuzio, Gasparini, McFarland, and Srikumarran
      • Familiari F.
      • Nayar S.K.
      • Russo R.
      • et al.
      Subacromial balloon spacer for massive, irreparable rotator cuff tears is associated with improved shoulder function and high patient satisfaction.
      adds further evidence about this newer and promising technique to address these difficult tears. It is one of the largest series of patients on the topic to date, with 51 patients followed up to completion. It also has one of the longer follow-up periods, with a mean follow-up period of 3 years. The results are comparable to those of prior studies that showed statistical improvement in functional outcome measures and range of motion. Constant-Murley scores showed statistically and clinically relevant improvement in range of motion (from 11 ± 5.4 to 34 ± 6.8) and strength (from 13 ± 5.4 to 28 ± 12). Moreover, 90% of patients reported satisfaction or excellent satisfaction at final follow-up.
      One interesting finding in the article is that Familiari et al.
      • Familiari F.
      • Nayar S.K.
      • Russo R.
      • et al.
      Subacromial balloon spacer for massive, irreparable rotator cuff tears is associated with improved shoulder function and high patient satisfaction.
      observed that a higher postoperative acromiohumeral interval was predictive of a lower Constant-Murley score at final follow-up. This seems counterintuitive because the balloon spacer is designed to restore a more normal acromiohumeral interval to allow for more normal shoulder kinematics. This finding goes against the design rationale. It makes me think that the balloon works more as a biological spacer or cushion between the humerus and the acromion rather than by truly restoring more normal shoulder biomechanics. It likely prevents bony friction between the surfaces, which helps with pain and function. I think my theory is backed up by the fact that the balloon is not meant to be functioning by 3 months postoperatively and is dissolved by 12 months, yet the results can persist for a few years. Many people have speculated that a superior capsular reconstruction functions in a similar manner. That is why some patients can still have improvements despite failure of healing of the graft at the glenoid and/or tuberosity.
      Although the results are promising for balloon spacers, there is much that is still not known about these devices. The study by Familiari et al.
      • Familiari F.
      • Nayar S.K.
      • Russo R.
      • et al.
      Subacromial balloon spacer for massive, irreparable rotator cuff tears is associated with improved shoulder function and high patient satisfaction.
      includes only patients who had undergone no prior surgical procedures and in whom 6 months of conservative care had failed. Most of the patients with irreparable cuff tears that I treat have undergone at least 1 prior operation for an attempted repair, if not multiple prior operations. Moreover, 6 months of conservative care is longer than most of my patients are willing to wait with a painful and nonfunctional shoulder. In addition, in the current study, there might have been some patients who could have undergone surgical repair if earlier intervention had been performed. Of the 51 patients, 6 ended up needing another surgical procedure: 5 received a reverse total shoulder arthroplasty and 1 underwent a latissimus dorsi transfer. No patient demographic data or information was presented that can help the reader determine what happened in these patients to result in surgical failure. What factors separated these patients from those who were satisfied? In addition, there has been no study to look at such patients months or years after their arthroplasties to let us know that they are not at an increased risk of prosthetic infection from the device that we have implanted and the resulting biological reaction.
      I await with eagerness more studies on balloon spacers as the surgical procedure is much faster and less technical than a superior capsular reconstruction or tendon transfer. Comparison studies between these different techniques are needed in the future and hopefully are being currently performed. We need to know whether these results hold up in patients in the long term or whether this treatment just buys the patient a couple of years before another operation. Do these results apply to patients in whom a rotator cuff repair has already failed, or does this treatment just work on untouched shoulders? I applaud Familiari et al.
      • Familiari F.
      • Nayar S.K.
      • Russo R.
      • et al.
      Subacromial balloon spacer for massive, irreparable rotator cuff tears is associated with improved shoulder function and high patient satisfaction.
      for helping to answer some questions about balloon spacers, but there are many more questions to answer before we can proceed without caution. The studies about balloons show promise, but we must make sure that we are not burning future bridges and risking outcomes in patients when this treatment does not work.

      Supplementary Data

      References

        • Chung S.W.
        • Oh J.H.
        • Gong H.S.
        • Kim J.Y.
        • Kim S.H.
        Factors affecting rotator cuff healing after arthroscopic repair: Osteoporosis as one of the independent risk factors.
        Am J Sports Med. 2011; 39: 2099-2107
        • Yamamoto N.
        • Mineta M.
        • Kawakami J.
        • Sano H.
        • Itoi E.
        Risk factors for tear progression in symptomatic rotator cuff tears: A prospective study of 174 shoulders.
        Am J Sports Med. 2017; 45: 2524-2531
        • O'Donnell E.A.
        • Fu M.C.
        • White A.E.
        • et al.
        The effect of patient characteristics and comorbidities on the rate of revision rotator cuff repair.
        Arthroscopy. 2020; 36: 2380-2388
        • Savarese E.
        • Romeo R.
        New solution for massive, irreparable rotator cuff tears: The subacromial “biodegradable spacer.”.
        Arthrosc Tech. 2012; 1: e69-e74
        • Holschen M.
        • Brand F.
        • Agneskirchner J.D.
        Subacromial spacer implantation for massive rotator cuff tears: Clinical outcome of arthroscopically treated patients.
        Ober Extrem. 2017; 12: 38-45
        • Piekaar R.S.M.
        • Bouman I.C.E.
        • van kampen P.M.
        • van Eijk F.
        • Huijsmans P.E.
        The subacromial balloon spacer for massive irreparable rotator cuff tears: Approximately 3 years of prospective follow-up.
        Musculoskelet Surg. 2020; 104: 207-214
        • Familiari F.
        • Nayar S.K.
        • Russo R.
        • et al.
        Subacromial balloon spacer for massive, irreparable rotator cuff tears is associated with improved shoulder function and high patient satisfaction.
        Arthroscopy. 2021; 37: 480-486